CRN: Thames Valley and South Midlands Annual Report 2014-15 Val Woods

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 CRN: Thames Valley and South Midlands
Annual Report 2014-15
Val Woods
Chief Operating Officer
NIHR CRN: Thames Valley and South Midlands Annual Report
2014/15
Host Organisation
Oxford University Hospitals NHS Trust
Partner
Organisations –
1.
2.
3.
4.
5.
6.
Members of the
Partnership Group
Other affiliated
partners
(eg CCGs/Social
enterprises)
Berkshire Healthcare NHS Foundation Trust
Buckinghamshire Healthcare NHS Trust
Milton Keynes Hospital NHS Foundation Trust
Oxford Health NHS Foundation Trust
Oxford University Hospitals NHS Trust
Royal Berkshire NHS Foundation Trust
1. NHS Aylesbury Vale CCG
2. NHS Bracknell and Ascot CCG
3. NHS Chiltern CCG
4. NHS Milton Keynes CCG
5. NHS Newbury and District CCG
6. NHS North and West Reading CCG
7. NHS Oxfordshire CCG
8. NHS Slough CCG
9. NHS South Reading CCG
10. NHS Windsor, Ascot and Maidenhead CCG
11. NHS Wokingham CCG
Host organisation Accountable Officer for CRN: Thames Valley and South Midlands
Name:
Sir Jonathan Michael
Contact details
Oxford University Hospitals NHS Trust
Chief Executive’s Office,
Level 3 John Radcliffe Hospital
Oxford
OX3 9DU
Email: [email protected]
Tel:
01865 221000
Host nominated Executive Director for CRN: Thames Valley and South Midlands
Name:
Dr Tony Berendt
Job title:
Medical Director
Contact details
Oxford University Hospitals NHS Trust
Chief Executive’s Office,
Level 3 John Radcliffe Hospital
Oxford
OX3 9DU
Email: [email protected]
Tel:
01865 572876
CRN: Thames Valley and South Midlands Clinical Director(s)
Name:
Dr Belinda Lennox
Contact details:
Department of Psychiatry
University of Oxford
Warneford Hospital
Headington
Oxford
OX3 7JX
Email: belinda.[email protected]
Tel:
01865 226491
Dr Andrew Protheroe
Co-Director
Contact details:
University of Oxford Department of
Oncology
Oxford Cancer & Haematology Centre
The Churchill Hospital
Headington
Oxford
OX3 7LJ
Email: [email protected]
Tel:
01865 572300
CRN: Thames Valley and South Midlands Chief Operating Officer
Name:
Valerie Woods
Contact details:
NIHR CRN: Thames Valley & South
Midlands
Oxford University Hospitals NHS Trust
Block 8
Nuffield Orthopaedic Centre
Oxford
OX3 7LD
Email: [email protected]
Tel:
01865 223292
Mob: 07774 751572
NIHR CRN: Thames Valley and South Midlands Annual Report 2014-15
Table of Contents
Overview .............................................................................................................................................. 1
Table 1: LCRN’s contribution to the 2014-15 High Level Objectives ................................................... 4
Table 2: LCRN’s contribution to the 2014-15 Specialty Objectives ..................................................... 9
Table 3: LCRN’s achievement against the 2014-15 Operating Framework Compliance Indicators .. 18
Table 4: Host organisation’s achievement against the 2015-14 Host Performance Indicators ......... 22
Appendix 1: LCRN Risk Register ...................................................................................................... 25
Key Highlights
The region recruited over 41,600 participants to Portfolio studies in 2014/15, compared with
39,500 in the prior year and the underlying number of studies also increased by 4% to 593.






Oxford University Hospitals NHS Trust (OUHT) was the third highest recruiting trust
with 17,827 participants and over 400 active studies (7% increase over prior year).
Oxford Health NHS Foundation Trust (Oxford Health) was the second highest
recruiting mental health trust, with over 2,000 recruits.
Milton Keynes University Hospital NHS Foundation Trust (MKUHFT) grew
recruitment by 24% to 3,188, with recruitment to commercial studies starting in early
2015/16, as a result of numerous ‘Expressions of Interest’ submitted in 2014/15.
Buckinghamshire Healthcare NHS Trust (BucksHT) has increased its number of
active studies by a further 5% to 70, expanding into several new Specialty areas
including opening studies in the Neurological Disorders Portfolio. It also remains one
of the leading trusts for recruitment to Cardiovascular commercial studies.
Royal Berkshire NHS Foundation Trust (RBFT) recruited over 5,400 patients into
trials and is now acting as the sole Research Sponsor for their first multi-centre,
Investigator Initiated study (POEM CCRN 16935). They also exceeded their target for
commercially funded studies opening an additional 8 studies during the year.
Berkshire Healthcare NHS Foundation Trust (BHFT) increased recruitment by over
90% to 421. In addition, both BHFT and RBFT are collaborating with Reading
University to develop a new Clinical Trials Unit which will enhance their ability to
deliver research across several areas including children’s anxiety and ageing.
In other areas, we have-
 Developed a comprehensive Workforce Development Strategy, built around the


Performance and Operating Framework, which is supported by an active Steering
Group drawing membership from all 6 divisions and partner trusts in the region. Our PPIE and Communications work has continued to develop with regular
newsletters, the development of promotional radio advertisements and a pilot
programme to enable patient groups to become more embedded within study teams
Our continuous improvement work is now well established. We have participated in
several green belt six sigma projects sending 3 participants to undertake projects in
primary care, RM&G and industry operations for site intelligence/site identification.
Challenges
We completed the transition from the previous Topic and Comprehensive network
structures. We appointed 3 new Research Delivery Managers and our core team members
were appointed to new job roles with effect from October 2014. Forthcoming changes to
governance processes under the Health Research Authority (HRA) have added a degree of
uncertainty but this has not led to a drop in performance. Delays in the new national Central
Portfolio Management System (CPMS) have also impacted on our ability to report accurately
on objectives and our LPMS solution will now be rolled out in 2015/16.
1
Key Successes
Several Specialties have shown impressive growth including Respiratory, Dermatology and
Gastroenterology and we have improved working across areas. For example, our Diabetes
research nurse team is linking in with Community diabetes education teams to access newly
diagnosed type 2 diabetes patients, normally only be seen in primary care settings.
DeNDRoN
The LCRN is one of the highest recruiters to DeNDRoN studies per head of population. Over
5% of people diagnosed with dementia were consented to dementia studies. The trust 70
day and the CRN 30 day ‘first patient first visit’ targets were actively monitored which
successfully extended the time available to recruit to studies. Locally, there are now
opportunities for involvement in clinical trials for people with mild memory problems, preclinical, mild, and moderate Alzheimer’s and vascular dementia, involving either novel drugs
or repurposed medications. Clinical trials of non-drug treatments are also available and for
those who are not able to commit to a clinical trial, observational opportunities (longitudinal
and cross-sectional) exist. 100% of trusts providing dementia services use the new Join
Dementia Research (JDR) database and we are working with GPs to promote the service.
Reproductive Health
Participant Recruitment to Reproductive Health and Childbirth Studies
8000
6000
OUHT
4000
BHT
RBFT
2000
MKUHFT
0
2012/13 2013/14 2014/15
All our maternity units are recruiting to the
Newborn Cross-Sectional Study (CCRN
8963), providing an opportunity for the
majority of women passing through the units
to participate in research. This has also
provided an excellent opportunity to promote
the CRN with promotional materials. Within
the lead site, OUHT, the newborn standards
developed as a result of the study have now
been introduced into clinical practice,
enabling patients to benefit rapidly from this
research.
Ebola Vaccine Studies
The LCRN played a key role in the set-up of the first commercial Ebola study in the UK and
two non-commercial sponsored studies as part of the global effort to combat the disease.
For each study we engaged early with the study teams to ensure swift study start-up,
enabling recruitment to start at the relevant NHS trusts within a median of 2 days of
receiving the valid research application.
Dr Matthew Snape, Chief Investigator of one of the trials (CCRN 18039), commented that
the LCRN’s “contribution has been an essential component of the Oxford Vaccine Group’s
ability to launch into a large phase 1 study at short notice”. The results of this study were
crucial to informing the design of further studies and provided an excellent opportunity for
our local population to contribute to this important research.
2
Priority areas
Commercial Activity
We have seen a significant increase in the number of open studies in this financial year to a
total of 117, although commercial activity remains low compared with other LCRNs. We
intend to further improve our capacity and capability and develop a more proactive approach
to engagement with commercial partners in 2015/16.
Primary Care
In 2014/15, a total of 5,821 patients were recruited to studies from primary care settings. We
believe there is still significant scope to grow and participate in more commercial studies. We
have appointed new GP Champions, introduced a new RSI scheme and improved
engagement with GPs. We have developed a new primary care strategy and we will focus
on implementing the actions arising from that during 2015/16 (including a restructure of our
delivery team).
Cancer
We remain one of the smallest networks for recruitment to Cancer studies but performance
is improving. We have appointed a new Research Delivery Manager and introduced new
management information and monitoring processes including a new Steering Group
structure. Recruitment to Surgery studies has been particularly low and we have identified a
number of issues including an inability to retain key staff. We are therefore developing an inhouse delivery team that will be managed by the LCRN and used flexibly.
Other Local Initiatives and Collaborations
We have been involved in a number of initiatives and collaborations in the year Quarterly ‘Infrastructure’ meetings with AHSN, BRC, BRU and CLAHRC and others
 Region-wide PPIE forum led by the AHSN to promote joint approaches
 Participation in the AHSN R&D Programme
 Several Clinical Research Leads also have theme roles within the AHSN
 One of our Research Delivery Managers is also a Network Manager for the AHSN
Involvement in National Groups
Members of the LCRN have been involved in many national roles including LCRN Clinical Director chairs the CRN Research Delivery Steering Group
 Mr Sion Glyn-Jones has been appointed as National Musculoskeletal Specialty Lead
 The Cross Divisional and Support Services Manager is also the study support
services link and sits on the National Strategy Board for the Study Support Service.
 Chief Operating Officer sits on Funding and Financial Management Steering Group
 Representation on National AcoRD Implementation Project Board and the Primary
Care Working Group
Conclusion
This has been a busy and productive first year of operation for the LCRN. We look forward to
continuing to work with all our stakeholders to deliver the CRN’s objectives throughout
2015/16.
3
CRN: Thames Valley and South Midlands Annual Report 2014-15
Table 1: LCRN’s contribution to the 2014-15 High Level Objectives
Objective
Measure
CRN
Target
LCRN GoalTarget
1
Number of participants recruited in a reporting year into NIHR
CRN Portfolio studies
650,000
Locally
determined HLO
goal for 2014-15
agreed with
National
Coordinating
Centre: 42,739
Increase the number of
participants recruited into
NIHR CRN Portfolio studies
Aspirational goal
for 2014-15:
42,739
LCRN actions-activities for 2014-15
Performance against plan
TV&SM LCRN covers a population across the 3
counties of c2.6m, representing 5% of the overall
population. On a national pro-rata basis, this would
translate to a local recruitment goal of 32,500.
However, the LCRN is proposing a higher target of
36,000 in recognition of
higher than average propensity of high recruiting
observational studies (especially UKCRN 8963)

strength of recruitment plans across several
Specialties as detailed in Appendix 4 of Annual
Plan
Overall recruitment has been strong. The LCRN was the 2nd highest recruiter
per head of population with nearly 2% of the local population recruited into
studies during the year.
Top 5 actions to support overall delivery against
target are listed below1. Ensure that performance against recruitment
target is a standing item on agenda for Executive
Group, Operational Management and the Clinical
Research Leadership Groups.
2. Translate overall LCRN target into 6 Divisional
targets (and related Specialty targets) and ensure
that these are reflected in the annual objectives
for RDMs, Clinical Leads and others as
appropriate
3. Develop effective suite of new reports from Open
Data Platform (ODP) to monitor performance
against recruitment targets on a monthly basis to
highlight variances against plan at an early stage
4. Develop Standard Operating Procedure (SOP),
to be used within each Division to ensure that
each Division
considers whether each new study identified
could run in more than 1 local trust

formally ‘horizon scans’ on at least a monthly
basis to identify new potential studies

benchmarks its performance against other
LCRNs on at least a quarterly basis to
identify good practice
5. Drive a more balanced Portfolio by
developing supplementary action plans for
the 7 Specialties which currently participate
in fewer than 10% of studies currently
recruiting nationally

regularly benchmarking recruitment by
Division, by county and by CCG where
appropriate, to identify priority areas for
increasing participation rates
2
Increase the proportion of
studies in the NIHR CRN
Portfolio delivering to
recruitment target and time
A:
Proportion of commercial contract studies achieving or
surpassing their recruitment target during their planned
recruitment period, at confirmed Network sites
80%
80%
1.
2.
3.
Ensure that performance against commercial
time and target metrics is a standing item on
agenda for Executive Group, Operational
Management and the Clinical Research
Leadership Groups
Embed robust feasibility process incorporating
feedback from Specialty Leads and trust RM& G
Managers to ensure that realistic targets are
agreed at an early stage and ensure that there is
LCRN Industry attendance at all pre-site
feasibility and site initiation visits
Develop a culture within the LCRN whereby
achievement of HLOs is recognised as a
The initial recruitment target for 2014/15 was increased by 18% to 42,739 to
support the CRN’s request to LCRNs for increased stretch in the targets. With
final recruitment of 41,691, the LCRN achieved 98% of this higher aspirational
target.
It should also be noted that the LCRN’s recruitment targets assumed
recruitment from Heatherwood and Wexham Park hospitals for the whole of
2014/5 would map to the region, whereas actual recruitment was mapped to
Frimley Health NHS FT (Kent, Surrey and Sussex LCRN) with effect from 1st
October 2014 onwards as a result of the restructure.
All our trusts (with the exception of except BHFT) recruited over 2,000
participants and the region continues to benefit hugely from the strength of the
collaboration between the University of Oxford and the local NHS
organisations.
The planned actions listed at the start of the year have underpinned the strong
recruitment performance. In particular
targets were developed for each Specialty and Division and included as
part of the objectives for the RDMs

recruitment performance was monitored in Executive Group, Operational
Management and the Clinical Research Leadership Group meetings

performance by Specialty and Division against other LCRNs was
benchmarked in monthly reporting packs

RDMs regularly horizon scanned for new studies and sought
opportunities to extend current studies to additional sites
Whilst steps have been taken to develop a more balanced portfolio across all
30 Specialties (with particular increases in Division 6 recruitment) further work
is planned to develop those Specialties which are still underrepresented (e.g.
Age and Ageing, Oral and Dental).
Performance against time to target is reported monthly at the LCRN Industry
Operations Meetings which include the industry team and senior management.
A standard set of reports has now been agreed at this meeting. Performance is
also presented at the Clinical Research Leadership Meetings quarterly.
The feasibility process has been remapped and revised. This is now
operational with a bespoke industry feasibility tracker. Specialty leads and
Trust R&D departments are seen as essential in this process and included in
communications to advise and ensure that realistic targets are set. All site
intelligence and site identifications are included in the industry tracker. Further
work continues to enhance the tracker and feasibility process as part of our six
lean sigma continuous improvement projects.
4
CRN: Thames Valley and South Midlands Annual Report 2014-15
Objective
Measure
CRN
Target
LCRN GoalTarget
LCRN actions-activities for 2014-15
4.
5.
business critical activity and develop a new
performance management process for use
across all the Divisions using consistent data
from local and national systems as appropriate
Develop flexible resource capacity within each
Division which can respond to urgent requests for
support
Introduce and embed new escalation policy
across the LCRN for all commercial studies to
address issues as soon as they are raised
Performance against plan
A senior industry team representative or Research Divisional Manager attends
all site initiation visits. Work is underway to ensure communications with trusts
and companies continues to improve in order that all Site Initiation Visits (SIVs)
are identified. Attendance is considered essential to maximise time to target
and identify potential first global recruits.
Flexible resource has been identified and recruited in specific divisions to add
capacity and resilience to further recruitment for commercial studies. Division 6
was considered a priority for this added resilience.
A documented escalation process is now in place.
B:
Proportion of non-commercial studies achieving or
surpassing their recruitment target during their planned
recruitment period
80%
80%
1.
2.
3.
4.
5.
3
Increase the number of
commercial contract studies
delivered through the NIHR
CRN
A:
Number of new commercial contract studies entering
the NIHR CRN Portfolio
600
n/a
1.
2.
3.
4.
5.
6.
Ensure that performance against time and target
metrics is a standing item on agenda for
Executive Group, Operational Management and
the Clinical Research Leadership Groups.
Ensure that achieving recruitment targets during
the planned period is included within the annual
objectives for RDMs and Clinical Leads and
others as appropriate
Implement Local Portfolio Management System
(LPMS) solution for the LCRN to enable real time
monitoring of time and target metrics
Validate planned targets for each site at an early
stage to ensure that they are feasible and agreed
by local PIs and resolve issues promptly
Develop effective suite of reports to monitor
performance against recruitment targets on a
monthly basis to highlight variances against plan
at an early stage consistently across each
Division
Performance against time and target metrics has improved during the year and
a number of steps have been introduced including additional review and
validation of study targets at an earlier stage as part of feasibility processes.
Develop new strategy for attracting commercial
studies in collaboration with key local and
national stakeholders to drive a step change in
volume of commercial studies. Consider use of
research capability funding to address any key
areas of opportunity or barriers identified
Improve range of approaches for recruiting to
commercial studies including
use of PIC, shared care sites, hub and
spoke

better techniques to identify potential
participants in primary care settings
Development of research interested databases or
opt-out systems
Develop series of promotional activities focussing
on the LCRN’s strengths with regard to
supporting commercial studies and hold industry
events in each of the 3 counties
Harmonisation strategy for governance approvals
for commercial studies to be agreed by Executive
Group and discussed by Partnership Board
Regular review meetings with trusts to identify
potential studies at an early stage so that can be
supported towards Portfolio adoption
The LCRN has seen a significant increase of the number of open studies in
this financial year to a total of 117 in the region, although it is recognised that
commercial activity is still low compared with other LCRNs.
However, a single metric for overall performance across the region cannot be
provided at this stage until CPMS and / or LPMS systems are fully
implemented. As an interim measure, activity reports are produced nationally
each month which detail time to target achievement for studies overall (i.e. for
all sites) listed by lead network and the LCRN’s performance is still below
target but comparable with other networks.
Current local recruitment performance is still therefore being monitored by the
LCRN and trust R&D departments via a number of local systems and
processes until the roll out of LPMS across partner organisations. This will now
be implemented in 2015/16 and will enable the LCRN to capture and monitor
performance on a consistent basis across the region.
The LCRN’s procedures and processes will be further developed in 2015/16 as
the new ‘study support service’ is rolled out.
The network continues to meet its HLO target for the number of trusts
recruiting to time and target. All but one trust (MKUHFT) has recruited to
commercial studies in 2014/15. We analysed possibilities for the remaining
trust and met with senior management to discuss commercial opportunities.
The site submitted several site identifications during the year and has now
been selected for several studies moving forward. Their first commercial study
opened in May 2015. This diabetes study (DIAB3992) is the first secondary
care site to open in the UK.
Monthly review meetings have been established with trusts to review site
intelligence, site identification and performance of all studies against targets.
Changes in targets and closure dates are regularly identified. The bespoke
industry tracker is used as a base to support these meetings.
To ensure that all studies were being captured appropriately, an analysis was
been undertaken at the Host trust demonstrating that 87% (for Q1 and Q2 of
2014/15) of the commercial studies given NHS Permission within the Host trust
were on the NIHR Portfolio. Several of those not on the portfolio were due to
eligibility reasons and not therefore considered as missed opportunities.
Harmonisation of governance is now considered the objective of the Health
Research Authority. However, harmonisation of costing and contracts has
been discussed in a series of meetings with finance and research and
development representatives from member trusts and is being taken forward in
2015/16.
The need to grow our commercial activity further is recognised as a key priority
for the LCRN. A draft strategy has been written which is currently out for
5
CRN: Thames Valley and South Midlands Annual Report 2014-15
Objective
Measure
CRN
Target
LCRN GoalTarget
LCRN actions-activities for 2014-15
Performance against plan
comment and addresses the following key objectives:

Capacity and Capability

Global Firsts

Performance

Primary Care

Secondary Care

Proactive engagement
B:
4
Reduce the time taken for
eligible studies to achieve
NHS Permission through
CSP
Number of new commercial contract studies entering
the NIHR CRN Portfolio as a percentage of the total
commercial MHRA CTA approvals for Phase II–IV
studies
Proportion of eligible studies obtaining all NHS Permissions
within 40 calendar days (from receipt of a valid complete
application by NIHR CRN)
75%
n/a
As above
This is based on overall NIHR CRN Portfolio and will therefore be monitored at
national level
80%
n/a
1.
The data below summarises our performance from CSP and ODP data for full
year performance for study wide checks and NHS Permission.
2.
3.
4.
5.
Ensure that performance against NHS
Permission metrics is a standing item on agenda
for Executive Group and Operational
Management Group.
Ensure that achievement of NHS Permission
metrics is included within the annual objectives
for the Cross Divisional and Support Services
Manager and others as appropriate
Perform review of overall structure to include
ensuring that there is an operational manager for
RM&G with a specific remit for delivery against
RM&G HLOs and KPIs
Maintain current weekly study wide meetings with
participation of key sponsors and open meetings
up to researchers.
Implement engagement programme with main
stakeholders to cover whole of research pathway,
signpost key activities and other service
providers and increase communications to all
stakeholders
**HLO4 (2014/15 Q1-3) – ODP data n=52 number of studies in 14/15 Q1-3 n=45, 85.54% of studies meeting 40 days, n=7 studies over 40 days HLO4 (2014/15 Q1-4) – data extracted from CSP n=66 number of studies in 14/15 Q1-4 n=16, 25.26% of studies meeting 40 days, n=50 studies over 40 days Study Wide (2014/15 Q1-4) (including eligibility process) n=107 number of studies completing study wide in 14/15 Q1-4 n= 83, 77.57% of studies meeting SW 15 days 10 days = Median of studies completing study wide in 14/15 Q1-4 *Study Wide (2014/15 Q1-4) (excluding eligibility process) n=97 number of studies completing study wide in 14/15 Q1-4 n= 84, 86.6% of studies meeting SW 15 days 9 days = Median of studies completing study wide in 14/15 Q1-4 NHS Permission (2014/15 Q1-4) n=392, number of NHS Permissions issued in 14/15 Q1-4 n=337, 85.97% of sites meeting local 15 days 7 days = Median of sites issuing NHS Permission in 14/15 Q1-4 Brief reflective commentary on local year to date performance for
2014/15: The CSP process timelines for CRN: Thames Valley and South Midlands are
exceeding the target of 15 days for study wide and local reviews, at 9 median
days* and 7 median days, respectively. The local year to date performance for
2014/15 is commendable in consideration of the transitional period for the local
networks. The study wide governance review have been completed within 15
calendar days for 86.6%* of studies and in the LCRN the local governance
reviews have been completed within 15 calendar days for 85.97% of research
sites, hence a high proportion of studies are processed in a timely manner via
CSP within the LCRN geography. It should be noted that, in common with
other networks, the LCRN has not been as successful in reducing the time
taken to achieve NHS permission through CSP for NIHR studies (HLO4), with
only 25.26%** of the proportion of studies obtaining NHS permission* within 40
calendar days (from receipt of a valid complete application) for 2014/15.
Actions have been identified to improve performance and LCRN core RM&G
delivery staff going forward will review performance for studies where CRN:
Thames Valley and South Midlands are the Lead CRN. In addition, further
development of the study support service will ensure a regular weekly review
of the performance of participating sites issuing NHS Permission within this
high level objective. 6
CRN: Thames Valley and South Midlands Annual Report 2014-15
Objective
Measure
CRN
Target
LCRN GoalTarget
LCRN actions-activities for 2014-15
Performance against plan
The performance metrics for RM&G were included in the annual objectives
both for the Cross Divisional Manager and all of the RM&G team within the
network. A review was completed for the research management and
governance team and a new lead was also recruited with a specific remit to
manage KPIs and HLOs for NHS Permissions and Study wide checks.
Metrics were discussed monthly at the RM&G manager meetings consisting of
the core team and representatives from the R&D departments in all member
trusts. The meetings also provided opportunities to engage with other
stakeholders to improve communication and frequent meetings were held with
research groups to discuss portfolio adoption and cost attribution guidelines.
Study wide meetings were held weekly to review every study coming through
governance and researchers were invited as appropriate. All studies
approaching limits were flagged and resolved where possible.
Despite Q4 of 2014/15 being the busiest on record for the LCRN, we still
maintained a median of 12 days for study wide reviews.
** There appears to be a discrepancy between how the HLO4 is calculated
when comparing the dashboard data within ODP (85.54% studies met HLO4)
and the raw data from the CSP Reporting Functionality within CSP Module
(25.26% studies met HLO4). This has been reported to the CRN Performance
Team for further investigation.
5
Reduce the time taken to
recruit first participant into
NIHR CRN Portfolio studies
A:
Proportion of commercial contract studies achieving
first participant recruited within 30 calendar days of
NHS Permission being issued or First Network Site
Initiation Visit, at confirmed Network sites
80%
80%
1.
2.
3.
4.
5.
B:
Proportion of non-commercial studies achieving first
participant recruited within 30 calendar days of NHS
Permission being issued
80%
80%
Ensure that performance against 30 day target is
a standing item on agenda for Executive Group,
Operational Management and the Clinical
Research Leadership Groups.
Ensure that achievement of 30 day metric is
included within the annual objectives for the
Cross Divisional and Support Services Manager,
RDMs and Industry team
Develop effective suite of reports to monitor
performance against 30 day targets on a monthly
basis to highlight potential issues at an early
stage
Introduce new escalation policy across the LCRN
for all commercial studies to address issues as
soon as they are raised
Regular meetings with trusts to include review of
performance against 30 day target and agree
improvement plans where required
Actions as above including ensuring that achievement
of 30 day metric is included within the annual
objectives for RDMs and relevant Divisional team
members
A Global First was achieved for a Cancer commercial contract study and the
30 day target was met.
In addition, RBFT recruited a second global recruit into their first ever
Children’s commercial study.
Performance has been closely monitored and was included in the objectives of
relevant team members and was discussed in Executive Group meetings. It
should be noted, however, that a single metric for overall performance across
the region cannot be provided due to the delays in implementing CPMS, and
hence LPMS, systems. Recruitment performance is therefore currently
managed by the LCRN and trust R&D departments via a number of local
systems and processes.
Monthly industry teleconference calls trusts are now in place. The team meets
regularly with OUHT and a documented escalation process is now in place.
It should be noted that a single metric for overall performance across the
region cannot be provided until CPMS and / or LPMS systems are fully
implemented.
Recruitment performance is therefore currently managed by the LCRN and
trust R&D departments via a number of local systems and processes. These
include the RPM system in OUHT (which is being developed as the new LPMS
system for the region). A total of 95% of eligible studies on the RPM system
are currently recruiting their first patent recruited within 70 days of receipt of
valid application (based on DH 70 day metric).
6
Increase NHS participation in
NIHR CRN Portfolio Studies
A:
Proportion of NHS Trusts recruiting each year into
NIHR CRN Portfolio studies
99%
99%
Maintain levels at 100% within region
All trusts within the region are actively engaged with the network and have
recruited to studies on the NIHR CRN Portfolio during the year.
7
CRN: Thames Valley and South Midlands Annual Report 2014-15
Objective
Measure
B:
Proportion of NHS Trusts recruiting each year into
NIHR CRN Portfolio commercial contract studies
CRN
Target
70%
LCRN GoalTarget
70%
LCRN actions-activities for 2014-15
Performance against plan
Regular review meetings with trusts to ensure that all
trusts within the region participate in commercial
studies developing specific action plans to address
any exceptions as appropriate
All trusts except one have recruited to commercial contract studies in 2014/15
and MKUHFT started to recruit in May 2015.
We therefore expect to achieve100% coverage for 2015/16.
Monthly meetings/teleconferences were held during the year to discuss site
identifications with member trusts.
C:
Proportion of General Medical Practices recruiting each
year into NIHR CRN Portfolio studies
25%
25%
Achieved 33% in current year (excluding 1 study
which skewed data) when including PIC based activity
within the metric
This will be monitored on quarterly basis by RDM and
Primary Care Lead Manager and included in annual
objectives
7
Increase the number of
participants recruited into
Dementias and
Neurodegeneration
(DeNDRoN) studies on the
NIHR CRN Portfolio
Number of participants recruited into Dementias and
Neurodegeneration (DeNDRoN) studies on the NIHR CRN
Portfolio
13,500
1,550 (final
target agreed
with national
CRN
Coordinating
Centre)
1.
2.
3.
4.
5.
Division 4 RDM to monitor recruitment activity
and time to target delivery to ensure that the
current portfolio delivers as expected with lead
nurse and senior nurses, operationalize monthly
recruitment meetings across locality teams:
monitor KPIs (TtT; FPFV); showcase successes
and closely monitor monthly recruitment targets
and recruitment strategies
Ensure that studies are set up in a timely manner
and reduce blockages to swift study set up with
100% obtaining NHS Permission at all sites
within 40 calendar days (from receipt of a valid
complete application by NIHR CRN)
Ensure that service level agreement is in place
across Oxford Health NSH FT and acute services
for the delivery of imaging/pathology services.
This will aid more rapid study set up and allow for
more use of single SSI forms and contracts
Division 4 RDM and clinical and theme leaders to
proactively build DeNDRoN pipeline and develop
new medical and non-medical PIs in the region.
Aim to work with 4 new PIs in dementia studies
(across Berkshire and Oxon/Bucks)
Ensure sufficient qualified global and
psychometric raters are available to support the
MH and DeNDroN portfolios by support of
national and local workforce development
activities within Division 4.
This is monitored on an ongoing basis and included in objectives of relevant
team members. A total of 23% of practices across the region recruited to site
based studies, with this figure rising to 55% if the Million Women study is
included.
Extending recruitment in primary care is a key priority for the LCRN and we are
undertaking a number of initiatives to develop our activities – and increase
participation outside Oxfordshire in particular.
DeNDRoN recruitment was strong (1 study has not been reported which would
increase this number by an additional 30). Monthly recruitment and delivery
meetings were held to monitor recruitment to target and problem solve
challenges.
All trusts achieved this metric which increases the duration of recruitment.
Trust 70 day targets and 30 day ‘first patient first visit’ targets were closely
monitored by both trusts and senior network staff.
This Service Level Agreement (SLA) came into effect in December 2014 and
has resulted in more streamlined and quicker set up processes for studies.
In the region, we delivered on a range of studies across all areas of the
DeNDRoN portfolio. In Berkshire in particular, we have started to engage with
a number of new PIs and in Oxfordshire / Buckinghamshire new medical PIs
are now acting as PIs. We now also have 8 active non-medical PIs in the
region.
We now have 2 PANSS and 2 DeNDRoN rater leads in the region, with a
growing number of staff who are competent to deliver these ratings for both the
non- commercial and commercial sectors.
In total, 3 staff attended DeNDRoN practice lead rater training during the year,
and 2 have attended PANSS rater lead training. 8 staff attended the rater
induction events, of whom 50% are rating on commercial studies
7 staff to have attended national rater training
programme and 3 staff to have attended national
practice lead training. 50% of newly trained staff in
2014/15 to be validated to rate on commercial
studies.
100% staff trained in 2013/14 to be validated to rate
on commercial studies
8
CRN: Thames Valley and South Midlands Annual Report 2014-15
Table 2: LCRN’s contribution to the 2014-15 Specialty Objectives
Unless stated otherwise, the following are national targets for 2014-15.
Specialty
Ageing
Ref.
Measure
Increase the opportunities for
patients to participate in NIHR
CRN Portfolio studies
Establish mechanisms by
which the age profile of NIHR
CRN Portfolio study
participants can be recorded
See
*
note
Increase the number of
Anaesthesia, Perioperative
Medicine and Pain
Management commercial
contract studies on the NIHR
CRN Portfolio
Number of new Anaesthesia,
Perioperative Medicine and
Pain Management commercial
contract studies entered onto
the NIHR CRN Portfolio
4
Establish links with the Royal
College of Anaesthetists’
Specialist Registrar networks
to support recruitment into
NIHR CRN Portfolio studies
Number of LCRNs where
Specialist Registrar networks
are recruiting into NIHR CRN
Portfolio studies
4
1
Maintain a minimum level of
participation in interventional
Cancer studies on the NIHR
CRN Portfolio
Recruitment to interventional
Cancer studies as a proportion
of LCRN cancer incidence
7.5%
2
Increase recruitment into
Cancer studies on the NIHR
CRN Portfolio overall
Recruitment to Cancer studies
as a proportion of LCRN
cancer incidence
20%
3
NIHR CRN Portfolio of Cancer
studies serves the full range
of cancer types in adults and
children
Proportion of adult and child
cancer types on the NIHR
CRN Portfolio
100%
Cancer patients across
England can participate in
Cancer studies on the NIHR
CRN Portfolio
Shared care arrangements
between NHS providers within
LCRN geographies
See
note*
5
Increase the proportion of
NHS cancer care providers
recruiting into NIHR CRN
Portfolio Cancer studies
Percentage of NHS cancer
care providers recruiting into
Cancer studies on the NIHR
CRN Portfolio
100%
6
Increase the proportion of
cancer patients offered
participation in research
Percentage of patients
reporting being offered
participation in research
through National Cancer
Patient Experience Survey
> 32%
1
Increase the number of
Cardiovascular Disease
commercial contract studies
on the NIHR CRN Portfolio
Number of new Cardiovascular
Disease commercial contract
studies entered onto the NIHR
CRN Portfolio
42
2
Increase access for patients
to Cardiovascular Disease
studies
Number of LCRNs contributing
to multi-centre studies in the 6
Cardiovascular Disease subspecialties
15
1
Anaesthesia,
Perioperative
Medicine and Pain
Management
1
2
Cancer
4
Cardiovascular
Disease
National
Target
Objective
LCRN actions to achieve objective(s)
Performance against plan
The LCRN does not currently capture the age profile of study
participants on a regular basis. Therefore we will consult with
our partners in Q1 to determine the best mechanisms to achieve
this. Options might include building on existing processes within
the DeNDRoN Specialty, use of LPMS or other local system
solutions.
The age of participants in studies is still not captured as a matter of course (although
the data is more readily available for some categories of study (such as DeNDRoN).
We are about to open a commercial pain study in Reading and
will seek to identify further opportunities with several potential
researchers and PIs across the region
Two commercial Anaesthesia studies (CCRN1019 and CCRN2020) were opened and
recruited in the year.
Both Reading and Oxford are participating in SNAP-1 Study (A
Sprint National Anaesthesia Project to survey patient reported
outcome after anaesthesia in UK Hospitals
We plan to explore the potential to capture this data more generally within LPMS once
that system has been rolled out across the region
A Sprint National Anaesthesia Project (SNAP-1) to survey patient reported outcome
after anaesthesia in UK Hospitals was set up and recruited well in all trusts resulting in
the following recruitment numbers OUHT (140), RBFT (108), BHT (106) and MKUHFT
(39).
Links with the Royal College of Anaesthetists’ Specialist
Registrar networks will be established during 2014/15 with the
support of the national Specialty group
Specialty leads have successfully engaged with the local Registrar network – OxDAT
(Oxford Deanery of Anaesthetist Trainees). Specialty lead and/or RDM will now
present at an OxDAT meeting in 2015 with a view to engaging the registrar network to
recruit to NIHR CRN Portfolio studies.
The region is currently achieving 6.3% of cancer patients
recruited to interventional studies (as % of NCRN cancer
incidence) for local trusts. Thus, achieving these targets in
2014/15 will be challenging.
The latest national data calculating recruitment to interventional studies as a
proportion of Cancer incidence in each of the LCRN regions ranges from 15.4% to
3.6%. The network’s performance – at 5.1% - is therefore below average.
We intend to work closely with all trust cancer teams to
encourage active recruitment to an appropriate portfolio of
studies, ensure there is effective PI support and work to
overcome barriers to recruitment within individual trusts.
We will perform an audit of all NHS cancer care providers to
ensure that we are offering opportunities to participate in cancer
studies right across the region
We will ensure that trust teams are aware of the National Cancer
Patient Experience Survey and develop specific strategies to
increase patient awareness of research.
The region has several key opinion leaders within
Cardiovascular who already participate in, or are investigators
for, commercial research studies. The LCRN will ensure that any
commercial studies that local leads are approached about are
signposted towards the NIHR adoption pathway and information
packs will be provided to clinical leads in order facilitate this.
We will identify investigators locally with specific expertise in
each of the six sub-Specialities, who are research active and
During the LCRN’s first year in operation, we undertook a number of initiatives which
are listed below and improving our Cancer recruitment remains a key priority for
2015/16

Monthly teleconferences/face to face meetings with the teams to increase
regular contact, share best practice

Recruitment to Cancer studies as a proportion of LCRN Cancer incidence
overall was approximately 15%

RDM attended the (Provider Based operational Delivery Groups (PBOG)
meetings for the sub Specialties in order to raise the profile of research and
encourage portfolio development

We discussed the ‘Big 5’ recruiting trials for each sub Specialty at the monthly
teleconferences/face to face meetings, benchmarking with other LCRN’s

All trusts took an active part in the OK To Ask Campaign 2014 which involved
many Cancer departments/team members

Shared Care Agreement across the network are in the process of being
reviewed and updated

31% of patients reported being offered participation in research from the
National Cancer Patient Experience Survey
The LCRN has developed a strong commercial portfolio in cardiovascular studies in
2014/15. One study led from the region opened within the financial year, two others
are in set up as a result of this support. Further studies are in discussion and being
actively promoted for portfolio inclusion, some by virtue of interactions via the Oxford
AHSN.
The LCRN has worked throughout the year with Cardiovascular clinical leads in the
region to promote and support the development and recruitment to the 6
Cardiovascular sub Specialities. In the last financial year, the LCRN supported
* No target as this is a qualitative objective assessed by a descriptive text from each LCRN
9
CRN: Thames Valley and South Midlands Annual Report 2014-15
Specialty
Children
Ref.
1
Objective
Measure
National
Target
Increase the number of
Children’s commercial
contract studies within the
NIHR CRN Portfolio in each
LCRN
Number of Children’s
commercial contract studies
on the NIHR CRN Portfolio
10%
2
All relevant sites that provide
services to children are
involved in research
Proportion of relevant sites
recruiting to Children’s studies
on the NIHR CRN portfolio
95%
3
Recruitment of children to
NIHR CRN Portfolio studies is
undertaken by individuals with
appropriate paediatric training
and experience, or who are
appropriately
Proportion of staff consenting
children to NIHR CRN Portfolio
studies who are paediatric
trained and/or experienced, or
who are appropriately
supervised
100%
LCRN actions to achieve objective(s)
Performance against plan
ensure they are familiar with the sub-Specialty portfolios within
Cardiovascular, as well as discuss/ identify with them NIHR
multicentre portfolio studies in the sub-Specialty areas that they
can participate in. Once identified, the network will work with
investigators to establish the feasibility of sites within the region.
recruitment into studies in all 6 of the sub Specialties.
The overall focus is on maintaining activity in Children’s Hospital
in Oxford and increasing recruitment in the DGHs by identifying
Consultants to act as PIs, supporting the research nurses
currently in post (including appointing at Stoke Mandeville) and
identifying appropriate studies to participate in.
34 studies recruited in 2014/15, 3 of which were commercial. A further 2 studies are
open but are yet to recruit. RBFT recruited their 1st participant into a Children’s
commercial study. OUHT recruited 13 participants into 2 commercial studies
We are in the process of building links with primary care for a
pneumococcal swabbing study (1200 recruits) and are at the
early stages of planning for a large meningococcal swabbing
study (up to 3000 recruits).
Objective 1

increase the number of commercial contract studies in the
locality

implement a process for feasibility assessment to ensure
appropriate studies are initiated by September 2014
Objective 2

open at least 2 paediatric research studies at each Trust in
the locality by March 2015

develop a process for accurate progress reporting to ensure
studies across the locality are conducted to time and target
by September 2014
Children’s Research Nurses have been appointed at all DGHs in the region, with the
individual at BucksHT starting in May 15. Portfolio studies open in all trusts except
BucksHT, due to the absence of a research nurse whilst they reappoint. EOIs in the
pipeline at all trusts to broaden the portfolio of studies
Children’s research nurses are available across the region and it is understood that all
studies have been delivered with appropriately trained staff.
Recruitment to Children’s research nurse posts in the DGHs was more challenging
than anticipated at the beginning of the year and the the region wide Senior Children’s
Research Nurse (job-share) posts have been integral to our success. A robust
induction and ongoing training plan is in place for all Children’s research nurses which
has resulted in staff being well supported and confident in developing the role within
each trust.
Plans for an annual Children’s focussed training meeting developed into a meeting for
all Division 3 research midwives/nurses and frontline staff. A successful event with
over 50 delegates was held in March 2015 in Oxford. This will become a bi-annual
event with the 2nd meeting planned for September in Reading.
Objective 3

conduct a scoping exercise of all individuals across the
locality involved in the recruitment of children to the portfolio
to identify paediatric training needs by September 2014

deliver an annual paediatric focussed training meeting to
link researchers locally by October 2014

implement programme to support paediatric research
nurses and support staff across the locality by June 2014
Critical Care
1
Increase the number of
intensive care units
participating in research
Proportion of intensive care
units recruiting into studies on
the NIHR CRN Portfolio
80%
Of the 5 intensive care units in the region, 4 are already active in
research. Oxford and Reading are well established and there
has been expansion into Stoke Mandeville and Wexham Park
ICUs more recently. We also aim to support Milton Keynes to
become research active during the year
Recruitment on 9 Critical Care studies during 2014/15 took place in four intensive care
units in Oxford, Reading, Slough and Milton Keynes. A period of reorganisation and
transition of intensive care services at Stoke Mandeville Hospital resulted in them not
participating in Critical Care studies during 2014/15 but this will be addressed in
2015/16.
Dementias and
Neurodegeneration
(DeNDRoN)
1
Implement arrangements for
local use of the “Join
Dementia Research system to
support study recruitment
A: Proportion of NHS Trusts
which provide dementia
services, which have put in
place generic arrangements
for access to medical
records, with consent, for
the “Join Dementia
Research” system users
50%
Objective 1A

appoint Project Manager with new LCRN funding received

develop local project plan to implement RAFT to recruit to
studies

work with Research Design Service and individuals
submitting funding proposals to promote use of database

facilitate governance arrangements in trusts to agree their
sign up to Join Dementia Research

agree systems for using Join Dementia Research which
complement pre-existing research interested databases

ensure that local studies eligible for Join Dementia
Research are routinely identified at set up stage and linked
to website

gain researcher agreement to recruit from Join Dementia
Research and support them with information
1A: Project manager came into post in December 2014. We have a JDR promotional
plan that is being executed and are working with GP surgeries to promote the service.
We have 2 JDR champions in our region who are active at promoting this service
100% of trusts that provide dementia services are using JDR to recruit to studies. 16
staff have been trained to use JDR; >3 in each trust. We have 3 super-users in JDR
10
CRN: Thames Valley and South Midlands Annual Report 2014-15
Specialty
Ref.
2
Objective
Increase the global and
psychometric rating skills and
capacity of LCRN staff
supporting Dementias and
Neurodegeneration
(DeNDRoN) studies on the
NIHR CRN Portfolio
Measure
National
Target
LCRN actions to achieve objective(s)
Performance against plan
B: Proportion of LCRN staff
working on Dementias and
Neurodegeneration
(DeNDRoN) studies trained
to use the “Join Dementia
Research” system
60%
Objective 1B

local project manager to nominate a minimum of 2 staff per
trust for Join Dementia Research training

Join Dementia Research accounts to be created for relevant
staff supporting DeNDRoN studies

training delivered to staff supporting DeNDRoN studies

local project manager to be the training champion

ensure staff are trained and equipped to use Join Dementia
Research
1B: We streamlined our existing dementia database with JDR registration. 16 studies
are recruiting using JDR, with 9 consented study participants identified via JDR to date
(18 May 2015)
A: Percentage of research
sites covered by at least 2
trained raters who are
registered on the national
rater database
80%
Objective 2A

ensure a minimum 10 DeNDRoN delivery staff on are on
the national rater register, with validated commercial
experience

develop 2-3 regional practice leads for both global and
psychometric rating

support Berkshire Healthcare NHS Foundation Trust to
develop its own qualified global raters from clinical
psychological services
2A and B: Each of our Dementia research sites have competent global and
psychometric raters. We now have active practice leads for DeNDRoN who are
executing a competency development plan for newer raters. During the year, 7 raters
were accepted to rate on commercial studies
Objective 2B

conduct skills audit and training needs analysis of staff
supporting DeNDRoN portfolio
 identify staff to attend CRN rater training programme; work
objective to attend training and develop/improve skills
ongoing into 6-monthly PDR cycles

identify psychometric/global practice lead to support local
raters

provide financial support for a minimum of 8 DeNDRoN
delivery staff to attend national psychometric and global
rater training in 2014/15
B: Proportion of LCRN staff
who support Dementias and
Neurodegeneration
(DeNDRoN) studies who
have successfully
completed rater training and
joined the national rater
database
35%
3
Improve access to research
for people living in care
homes
Proportion of registered care
homes participating in NIHR
CRN Portfolio studies
20%
4
Increase clinical leadership
capacity and engagement in
each of the main disease
areas in the Dementias and
Neurodegeneration
(DeNDRoN) specialty
Number of LCRNs with local
clinical leads in each of the
main disease areas
(dementias, Parkinson’s
disease, Huntington’s disease
and motor neurone disease)
15
Objective 3

identify ENRICH project lead who will work with county
leads to ensure local ENRICH development & to participate
in national monthly ENRICH Delivery Team meetings

provide project management support to contribute to
national programme and implement local delivery of
ENRICH

develop database of care homes across LCRN region

develop and implement an engagement strategy to raise
awareness

work with local researchers to prioritise support for care
home research (study development and delivery activity)

attempt to recruit participants from care home settings
where protocol allows

establish baseline care home participation rate from
2013/14 recruitment data
3: We have not been able to achieve this objective. As the Numerator became
ENRICH registered care homes undertaking CRN portfolio studies and the
Denominator became care homes registered with the ENRICH programme, our
achievement was 0/18. However 38 care homes in our region have been involved with
portfolio studies (WHELD and DCM epic)
Objective 4

identify senior leader in LCRN to take overall responsibility
for delivering the dementia plan and clinical research leads
for the 4 disease areas (Dementia, HD, MND, PD)

RDM and clinical director to support lead research nurse
and senior research nurses to provide professional
leadership to delivery staff and contribute to divisional
workforce development plans
4: In 14/15, we funded leads for PD and Dementia, and non-funded leads for MND and
HD.
11
CRN: Thames Valley and South Midlands Annual Report 2014-15
Specialty
Dermatology
Ref.
1
Objective
Measure
Increase the opportunities for
patients to participate in
Dermatology studies on the
NIHR CRN Portfolio
A: Proportion of health care
providers of dermatology
services recruiting into
Dermatology studies
B: Number of 'wounds'
treatment centres recruiting
into wounds trials
National
Target
50%
30
LCRN actions to achieve objective(s)
Performance against plan
Whilst Oxford recruits the vast majority (approx. 90-95%) of
Dermatology patients within the region, there have been recruits
from Stoke Mandeville, Amersham, Milton Keynes and Royal
Berkshire. We will continue to encourage more recruitment from
other centres through the use of our regional Dermatology
meetings and one-to-one discussions.
Dermatology had a successful year, sitting in 2nd place nationally for recruitment.
There was been activity at 3 of the 4 DGHs – but it is acknowledged that further work
can be done to increase access to more studies across the region.
The number of commercial studies has increased from 0 in 13/14 to 2 in 2014/15 with
further studies in the pipeline.
It is likely that wound studies are included in various Specialties
at present (e.g. surgery) so we will analyse our local portfolio
and seek to promote such studies across the region.
We will also improve links with primary care, minor injuries units
and the ambulance service to explore this in more detail
Diabetes
1
Achieve a minimum level of
participation in diabetes
studies
Proportion of people with
diabetes (prevalence rates)
recruited into Diabetes studies
on the NIHR CRN Portfolio
0.5%
2
Increase the number of newly
diagnosed people with type 1
diabetes in research
Proportion of patients
identified via ADDRESS 2
recruited into Diabetes studies
on the NIHR CRN Portfolio
5%
3
4
Increase the proportion of
NHS providers recruiting into
Diabetes studies on the NIHR
CRN Portfolio
Improve the referral systems
in place for newly diagnosed
people with type 1 diabetes
A: Proportion of primary care
providers recruiting
participants into Diabetes
studies on the NIHR CRN
Portfolio
4%
B: Proportion of secondary
care providers recruiting
participants into Diabetes
studies on the NIHR CRN
Portfolio
83%
Proportion of secondary care
trusts with referral systems in
place for newly diagnosed
people with type 1 diabetes
80%
Objective 1 translates into a target for the region of 562
participants. Recruitment into Diabetes studies on the portfolio in
2013/14 exceeded the target of 0.5% of the diabetes population.
To continue to meet this level of recruitment, the portfolio of
diabetes studies in secondary care will need to be maintained
and activity into primary care sites, expanded. Increasing activity
in primary care sites is portfolio dependent but we believe that
recruitment into the DARE study will make a significant
contribution to this objective in the financial year 2014/15.
All secondary care centres in the region have a balanced
portfolio of diabetes studies and are actively recruiting
participants into ADDRESS2. The ADDRESS2 database is used
on a routine basis in order to identify patients for suitable studies
at the LCRN level. It is also used at the national level, with
patients identified in our region routinely contacted. All potential
participants at active sites are provided with information and
approached about participating in ADDRESS2.
Objective 3a translates into an increase from 44 to 46 primary
care providers. In the geographic region covered by the LCRN, 3
CCGs have research active practices that recruit into Diabetes
studies, and both academic and commercial studies are
recruiting in primary care. Recruitment is expanding in primary
care settings where available portfolio permits. The network is in
discussion with the Diabetes lead for each CCG and has
identified potential expansion in areas with limited activity on the
basis of recent implementation of strategic infrastructure for
several CCGs. We also anticipate activity will increase in
2014/15 as the DARE study is widely promoted in primary care
sites.
1: The Diabetes Specialty recruited 1,968 patients into portfolio studies in 2014/15,
exceeding the local target for the year.
2: Due to change in the way that the ADDRESS2 database is now managed it is not
possible for the LCRN to have complete oversight of all of the patients that are
approached and asked to participate in studies by the national coordinating team.
However, to our knowledge there were 24 requests to participate in studies to patients
in the ADDRESS2 database in 2014/15 including those from the local team and
national coordinators. This from a 154 patients recruited and on the database, 51 of
these patients were recruited in 2014/15.
3A: Recruitment by primary care sites remains below average low in the region with a
total of 8 GP sites across 5 CCGs supporting recruitment into Diabetes studies in
2014/15. Although some progress has been made, particularly around engagement in
commercial studies, and supporting PIC studies, this is not fully reflected in the
number of sites recruiting into Diabetes studies. This remains a priority for 2015/16
and the development of a Primary care Research Strategy is expected to further
enhance delivery of Diabetes studies in GP sites during the coming year.
3B: All secondary care providers recruited into Diabetes studies in 2014/15
4: All secondary care providers now in place for newly diagnosed type 1 diabetes
patients.
All secondary care providers are currently recruiting to Diabetes
studies. We anticipate this will remain the case in 2014/15.
Ear, Nose and
Throat (ENT)
1
Increase the number of ENT
commercial contract studies
on the NIHR CRN Portfolio
Number of new ENT
commercial contract studies
entered onto the NIHR CRN
Portfolio
2
We recognise that the number of commercial studies nationally
is limited and we will seek to develop a strategy that strengthens
links with potential commercial partners in the region
Recruitment took place on 5 ENT studies during 2014/15. These were all noncommercial studies. A new ENT Specialty Lead has now been recruited and will work
with the RDM to develop a strategy to strengthen links with commercial partners.
Gastroenterology
1
Increase the proportion of
patients recruited into
Gastroenterology studies on
the NIHR CRN Portfolio
Number of participants (per
100,000 population), recruited
into Gastroenterology studies
on the NIHR CRN Portfolio
10
For our population, this would translate into a target of 560
participants which is reasonable if studies co-adopted by
Gastroenterology are included alongside those which are led by
the Specialty and all local trusts currently recruit to studies.
2
Increase the number of NHS
Trusts actively participating in
Gastroenterology studies on
the NIHR CRN Portfolio
A: Proportion of NHS Trusts
participating in
Gastroenterology studies on
the NIHR CRN Portfolio
90%
Recruitment to studies where Gastroenterology was listed as the main Specialty
increased to 252 with 13 studies actively recruiting during 2014/15. Gastroenterology
research staff also contributed to other studies listed as co-adopted to
Gastroenterology. There was a relatively high proportion of recruitment to
interventional versus observational studies (75%) and the inclusion of a relatively large
observational study within the portfolio for 2015/16 will help to provide balance and
increase numbers.
We have a very active commercial Portfolio in Oxford, and we
will seek to expand participation to other sites across the region
during the year
12
CRN: Thames Valley and South Midlands Annual Report 2014-15
Specialty
Ref.
Objective
Measure
National
Target
B: Proportion of NHS Trusts
participating in
Gastroenterology
commercial contract studies
on the NIHR CRN Portfolio
35%
LCRN actions to achieve objective(s)
Performance against plan
There was participation in Gastroenterology studies across the network with
recruitment taking place at OUHT, RBFT, BHT and MKUHFT.
The Specialty is also a strong recruiter to commercial studies, with an increased
proportion of recruitment to commercial versus non-commercial studies (55%).
Genetics
1
Increase access for patients
with rare diseases to
participate in Genetics studies
in the NIHR CRN Portfolio
Number of LCRNs participating
in multi-centre genetics studies
through the NIHR UK Rare
Genetic Disease Research
Consortium
14
We will work with the national Specialty Group to identify the
studies which form part of this Consortium and aim to recruit to
such studies in 2014/15
The Genetics research team which is based in Oxford have had a difficult year with
regards to staffing. However, recruitment targets were succeeded, 2 new research
genetic counsellors have now been appointed and a clear plan is in place to start
actively recruiting to open studies, particularly those under the Consortium.
Haematology
1
Increase the participation of
NHS organisations in
Haematology studies on the
NIHR CRN Portfolio
A: Number of open
Haematology studies in
each LCRN
4
B: Number of open
Haematology commercial
contract studies in each
LCRN
1
Recruitment to studies in the Haematology portfolio has remained low as the studies
open in the region sit predominantly in other Specialties. 2 large studies are in the
pipeline to be opened and resource has been allocated to the Specialty to support the
development of capacity.
2
Increase the involvement of
haemophilia centres in
supporting Haematology
studies on the NIHR CRN
Portfolio
A: Proportion of haemophilia
centres recruiting patients
into Haematology studies on
the NIHR CRN Portfolio
(comprehensive care)
90%
Since many studies (neo-natal/ platelets/ transfusion/
thrombosis) are co-adopted to other Specialty Groups, an
increase in the Haematology-led portfolio could be challenging.
Also, often haematology studies are only accessible in larger
hospitals so it is not always appropriate to expand to DGH’s.
However, the region is currently in the top 5 of recruiters
nationally and there is an intention to improve on this
performance and also increase the number of commercial
studies running locally
B: Proportion of haemophilia
centres recruiting patients
into Haematology studies on
the NIHR CRN Portfolio
(large centres)
50%
There is only one dedicated Haemophilia centre in the region –
Oxford. The centre already recruits to commercial studies and
we will endeavour to expand this. We will also consider
appointing a specific lead for Haemophilia studies.
A joint appointment was made to the Specialty Lead role and there is a lot of
enthusiasm to develop the specialty.
Hepatology
1
Increase access for patients
to Hepatology studies on the
NIHR CRN Portfolio
Number of LCRNs contributing
to a multi-centre study in all of
the six major study areas (viral
hepatitis, NAFLD, autoimmune
liver disease, metabolic liver
disease).
15
The region has recruited to 9 Hepatology studies in 2013/14. We
will seek to increase this number in 2014/15 and aim to have
active research in each of the study areas listed
The number of recruiting studies where Hepatology was listed as the main Specialty
increased to 13 during 2014/15. Hepatology research staff also contributed to other
co-adopted studies. Out of the 13 Hepatology studies, 11 are multi-centre studies
covering all of the major study areas listed.
Infectious
Diseases and
Microbiology
1
Increase awareness of the
Infectious Diseases and
Microbiology specialty through
the identification of a local
champion
Number of LCRNs with an
identified clinical local
champion for infectious
disease public health
emergencies
15
We will identify a clinical local champion for infectious disease
public health emergencies
Dr Dushyant Mital was identified as a clinical local champion for infectious disease
public health emergencies and has contributed to national meetings and policies.
We will identify and open suitable antimicrobial resistance
research studies in the region
2
Increase access for patients to
Infectious Diseases and
Microbiology studies on the
NIHR CRN Portfolio
Number of LCRNs recruiting
into antimicrobial resistance
research studies on the NIHR
CRN Portfolio
15
At least four of the Infectious Diseases and Microbiology studies recruiting in the
region during 2014/15 relate to antimicrobial resistance research including; The
ARREST Trial; Oral vs Intravenous Antibiotics (OVIVA) for Bone and Joint Infection;
Respiratory Virus Hospitalization Study; and Respiratory Virus Outpatient Study.
1
All NHS major trauma centres
to support recruitment into
NIHR CRN Portfolio studies
Proportion of NHS major
trauma centres recruiting
participants into NIHR CRN
Portfolio studies
100%
The John Radcliffe Hospital in Oxford is the only major trauma
centre in the region and both the emergency department and the
orthopaedic department at the hospital regularly recruit to
portfolio studies.
Recruitment took place in the major trauma unit in Oxford and across other emergency
departments in the region.
2
Increase the number of NHS
emergency departments
supporting recruitment into
NIHR CRN Portfolio studies
Proportion of NHS emergency
departments recruiting into
NIHR CRN Portfolio studies
30%
Injuries and
Emergencies
We currently recruit in 66% of emergency departments in the
region. Emergency departments at Reading, Milton Keynes, and
Wexham Park all recruit to portfolio studies but research has not
expanded to Stoke Mandeville or the Horton Hospital and we will
endeavour to extend studies to these sites.
Recruitment to Injuries and Emergencies studies in area increased by 13% to 398
during 2014-15 and the Specialty is well supported by active I&E Specialty meetings
which are held three times a year.
Research staff in Injuries and Emergencies also contributed significantly to recruiting
participants to studies co-adopted with other Specialities (e.g. Musculoskeletal,
Neurological, Stroke, Haematology, Cardiovascular and Respiratory) and several
portfolio studies where recruitment did count for accrual.
Recruitment to Injuries and Emergencies studies took place in three emergency
departments (Oxford, Reading and Wexham Park) during 2014-15 whilst research
staff in the emergency department (ED) at Stoke Mandeville successfully recruited to
other studies co-adopted with other Specialities. Two research nurses in ED at Milton
Keynes have now been recruited and several studies set up, including Crash 3 which
13
CRN: Thames Valley and South Midlands Annual Report 2014-15
Specialty
Ref.
Objective
Measure
National
Target
LCRN actions to achieve objective(s)
Performance against plan
started recruiting in April 2015.
Mental Health
1
2
Metabolic and
Endocrine
Disorders
Musculoskeletal
Increase the number of
principal investigators
supporting Mental Health
commercial contract studies
Number of principal
investigators working on open
Mental Health commercial
contract studies on the NIHR
CRN Portfolio
95
Maintain the skills and
capacity of staff supporting
Mental Health Portfolio
studies in frequently used
Mental Health study eligibility
assessments (e.g. PANSS)
Number of staff trained in
frequently used Mental Health
study eligibility assessments
139
1
Support patient access to
Metabolic and Endocrine
Disorders studies on the NIHR
CRN Portfolio
Number of LCRNs supporting
established studies of rare
diseases in metabolic and
endocrine disorders
15
2
Increase the number of
Metabolic and Endocrine
Disorders studies on the NIHR
CRN Portfolio
Number of new Metabolic and
Endocrine Disorders studies
on rare diseases entering the
NIHR CRN Portfolio
4
1
Increase the opportunities for
patients to participate in
Musculoskeletal studies on the
NIHR CRN Portfolio
Proportion of Musculoskeletal
service providers recruiting
into NIHR CRN Portfolio
studies
75%
2
Increase the number of
Musculoskeletal commercial
contract studies on the NIHR
CRN Portfolio
Number of new
Musculoskeletal commercial
contract studies entered on to
the NIHR CRN Portfolio
30
Objective 1

increase to 20 PIs over the next year, using non-medically
training PIs as appropriate

promote LCRN support to clinicians and AHPs across MH
trusts

understand barriers and drivers to increasing PIs in MH
commercial studies

develop PI/ clinician training with workforce development
lead

survey clinicians for special interests and try to match new
studies to interest

map potential growth areas and offer mentoring, training
and support
8 new PIs have taken part in Mental Health studies who had no previous experience of
being PIs on studies. There are now >30 active PIs in the region. We have had 1
commercial study open in Mental Health. However, this is growing rapidly and for
2015/16, we have been notified of site acceptance for 6 commercial trials thus far, with
new PIs becoming involved.
We anticipate that our 2 mental health trusts will also become involved in further
commercial studies for which site interest has been submitted
We have 20 certified PANSS raters in our region and 2 practice leads who were
trained in March 2015. The RDM is meeting the rater leads in May 2015 to develop a
plan for developing and building competencies. A programme plan is in draft stage
Objective 2

with lead nurse and workforce development lead, identify
staff training needs and identify practice leads to increase
the numbers of staff trained and qualified to conduct
assessments

arrange local training events to support the above
The network will work with local clinical leads to identify studies
in rare diseases in metabolic and endocrine disorders. We will
liaise with the coordinating centre responsible for metabolic and
endocrine studies in order to clarify which studies on the current
portfolio are classified as rare diseases and how these are
defined
We will work with researchers to ensure that any local studies
being developed are signposted towards the NIHR adoption
pathway.
The LCRN supported recruitment into three Metabolic and Endocrine rare disease
studies and promoted the studies available to new sites across the region as
appropriate for these studies
All acute trusts recruited to studies in 2013/14 although
recruitment was heavily skewed towards the Nuffield
Orthopaedic Centre in Oxford. We will endeavour to expand
participation outside Oxford in 2014/15 and investigate other
potential sites.
All trusts recruited to the Musculoskeletal (MSK) portfolio in 2014/15 but there is still
further work to be done to extend the reach of the portfolio beyond the Nuffield
Orthopaedic Centre in Oxford and across the region.
There has been a lot of ongoing work to engage with primary care to enhance the
delivery of studies, the benefits of which should be seen in 2015/16.
We have increased our adoption of commercial studies, with
particular focus on implantable devices. The service has also
engaged industry at a high level, both directly and through
international and local meetings which has heightened
awareness in the device industry, in particular, and has
improved the quality of the commercial surgical trials submitted.
There are several current proposals in the pipeline and it is likely
that the number of commercial studies will increase significantly
during the next 3 years, following recent NICE guidance on the
introduction and adoption of new orthopaedic devices in the
NHS. Our region is spearheading an initiative focused on the
early-phase assessment of new orthopaedic devices.
Neurological
Disorders
1
Increase the number of NHS
Trusts recruiting into
Neurological Disorders
studies on the NIHR CRN
Portfolio
Number of previously inactive
NHS Trusts which now are
recruiting into Neurological
Disorders studies on the NIHR
CRN Portfolio
15
2
Increase the number of
principal investigators
supporting Neurological
Number of principal
investigators working on open
Neurological Disorders
58
Objective 1

promote LCRN support to neurologists and AHPs across
acute trusts

map potential growth areas and offer mentoring, training
and support

develop PI/ clinician training with workforce development
lead

survey clinicians for special interests and try to match new
1: BucksHT now has a Neurological Disorders portfolio, which it has not had
previously. There has been significant growth in the range of Neurological Disorders
studies taking place in Oxford outside of MS studies, e.g. a commercial epilepsy study,
commercial headache study, antibody-mediated CNS conditions. Commercial
migraine and CIPD studies are in set up. As the division 4 nursing team are becoming
more competent at supporting a wider range of studies, the MS portfolio is also
starting to expand
14
CRN: Thames Valley and South Midlands Annual Report 2014-15
Specialty
Ref.
Objective
Measure
Disorders commercial contract
studies
commercial contract studies
on the NIHR CRN Portfolio
National
Target
LCRN actions to achieve objective(s)
studies to interest
Objective 2

increase by 5 new PIs

understand barriers and drivers to research involvement

support PI/clinician training

survey clinicians for special interests and match new
studies to interest

map for potential growth areas and offer mentoring, training
and support
Ophthalmology
1
Increase the number of
Ophthalmology commercial
contract studies on the NIHR
CRN Portfolio
Number of new
Ophthalmology commercial
contract studies entered onto
the NIHR CRN Portfolio
4
2
Increase the number of NHS
Trusts participating in
Ophthalmology research
Number of NHS Trusts
recruiting patients into
Ophthalmology studies on the
NIHR CRN Portfolio
100
Oxford is very active in ophthalmology research with a number
of experienced CIs and PIs. It has an impressive track record in
cutting edge commercial studies and we will seek to develop the
commercial portfolio further
However, the LCRN has fewer studies overall than most other
regions and we aim to increase this. There was active
recruitment at 3 trusts during 2013/14 and we will work to extend
research to Wexham Park and Milton Keynes in 2014/15
Performance against plan
2: 5 new PIs are active in neurological conditions studies; 2 of these are commercial
studies
3: The network overachieved its recruitment target for the Specialty: 313 (actual)/250
(target)
The Eye Research Group Oxford at the Oxford Eye Hospital has facilitated recruitment
of 473 participants to 6 studies during 2014/15 with studies recruiting in OUHT, RBFT
and BucksHT. Three of these studies were commercial studies.
A meeting in planned in June 2015 will bring together the Specialty Lead (Prof
Downes) and existing and potential PIs from BucksT, MKUHFT and RBFT to explore
barriers and encourage participation from across the region in recruiting to
Ophthalmology studies and in particular commercial studies.
It is hoped that these will become regular quarterly Specialty meetings.
Oral and Dental
1
2
3
Primary Care
1
2
Increase the opportunities for
patients to participate in NIHR
CRN Portfolio studies
Number of Oral and Dental
studies on the NIHR CRN
portfolio recruiting in each
LCRN
1
Increase the number of Oral
and Dental commercial
contract studies on the NIHR
CRN Portfolio
Number of open Oral and
Dental commercial contract
studies on the NIHR CRN
Portfolio
Offer a balanced portfolio of
studies to practitioners and
participants
A: Proportion of Oral and
Dental studies on the NIHR
CRN Portfolio recruiting
from a primary care setting
20%
B: Proportion of participants
recruited from a primary
care setting into Oral and
Dental studies on the NIHR
CRN Portfolio
50%
A: Proportion of GP sites
registered as research
capable1
35%
B: Proportion of GP sites within
any individual CCG
registered as research
capable
5%
Number of LCRNs with a
community pharmacy
Research Champion
15
Increase the opportunities for
patients to participate in NIHR
CRN Portfolio studies
Improve research
engagement with community
pharmacy
2
There are no dental schools in the region so the potential to
recruit to studies is limited (although we have recruited to a cleft
palate study in 2013/14)
We will identify suitable studies and work with primary care to
develop a strategy so that we can start to offer research to
participants in a primary care setting.
Cleft palate research has continued successfully but as anticipated, there has been no
other recruitment to studies on the Oral and Dental portfolio.
We have started discussions have started with CRN: Wessex to work jointly with the
Oxford Dental Deanery and Bristol Deanery, through the Dental Dean for Health
Education Thames Valley
The development of an Oral and Dental health portfolio has been included in the
Primary Care Strategy.
Proportion of GP sites registered as research capable
This is currently assessed and monitored informally. As part of
the RSI scheme, a system to formally record the degree that
sites are research capable will be introduced
The RSI scheme was launched in Q4. 5 practices are now formally registered as
Research Ready and this number is expected to increase in 2015/16. 23% of practices
across the region recruited to site based studies, with this figure rising to 55% if the
Million Women study is included.
This year, 33% of practices have contributed to site based
studies, many recruiting patients into studies
All 11 CCGs reported recruitment activity in 2014/15. Activity is still skewed towards
Oxfordshire CCG but the impact of the launch of the RSI scheme should be seen in
2015/16.
Proportion GP sites registered as research capable within each
CCG
Analysis of this year’s data shows that of the 11 CCGs in the
region, all have surgeries contributing to site based NIHR
studies (ranging between 3% and 57% of surgeries).
A commercial pharmacy study was opened in Q4 at 2 sites and pharmacies in Milton
Keynes are engaged in the set-up of a non-commercial study. A pharmacy champion
has not yet been appointed but through the links identified it is hoped that a suitable
and interested candidate will be identified.
If current capability levels of are maintained, Milton Keynes CCG
will require further support in order achieve the objective
These will be added as performance objectives to the RDM and
Primary Care Lead Manager roles
1
Registered Research Capable Sites are those sites working with the LCRN which have the capacity and capability to support NIHR CRN activities
15
CRN: Thames Valley and South Midlands Annual Report 2014-15
Specialty
Ref.
Objective
Measure
National
Target
LCRN actions to achieve objective(s)
Performance against plan
Number of LCRN’s with a community pharmacy research
champion.
We aim to appoint a community pharmacy Research Champion
during 2014/15.
Renal Disorders
Reproductive
Health and
Childbirth
Respiratory
Disorders
1
Increase the proportion of
Renal Disorders commercial
contract studies on the NIHR
CRN Portfolio
Proportion of commercial
contract studies in relation to
the total number of Renal
Disorders studies on the NIHR
CRN Portfolio
20%
2
Improve the promotion of
research to patients with
Renal Disorders
Proportion of renal units
actively promoting research to
patients
50%
1
Increase the number of
Reproductive Health and
Childbirth commercial contract
studies on the NIHR CRN
Portfolio
Number of Reproductive
Health and Childbirth
commercial contract studies
on the NIHR CRN Portfolio
2
Increase engagement and
awareness of the
Reproductive Health and
Childbirth Specialty
Number of LCRNs with an
identified midwifery champion
to increase engagement and
awareness
15
1
Increase access for patients
to participate in Respiratory
Disorders studies on the NIHR
CRN Portfolio
Number of LCRNs recruiting
participants into studies in the
Respiratory Disorders main
disease areas of asthma,
COPD and pneumonia
15
Increase the number of
participants recruited into
COPD and Asthma studies on
the NIHR CRN Portfolio
Percentage of COPD and
Asthma participants recruited
into Respiratory Disorders
studies on the NIHR CRN
Portfolio
10%
Increase the proportion of
patients recruited into Stroke
randomised controlled trials
on the NIHR CRN Portfolio
Number of patients (per
100,000 population) recruited
into Stroke randomised
controlled trials on the NIHR
CRN Portfolio
8
Increase the number of
commercial Stroke studies on
the NIHR CRN Portfolio
A: Number of new commercial
contract Stroke studies on
the NIHR CRN Portfolio
5
B: Number of new medical
technical studies in Stroke
on the NIHR CRN Portfolio
2
2
Stroke
1
2
4
The network will work with local clinical leads to ensure that any
commercial studies that they are approached about are
signposted towards the NIHR adoption pathway. Information
packs will be provided to clinical leads in order facilitate this.
The local clinical leads actively signposted approaches form commercial organisations
to the NIHR portfolio to ensure adoption pathway was highlighted. In 2014/15 this
resulted in a commercial study that was in discussion being forwarded to the national
coordinating centre.
In 2013/14, the region recruited to Renal studies in all acute
trusts apart from Heatherwood and Wexham Park NHS FT. For
2014/15, the LCRN will work with the clinical teams in all Renal
units across the region to support any studies that may be
suitable for these trusts as part of the development objectives for
Division 2 in the region. Promoting research opportunities across
the region will form part of the PCPIE work stream for Division 2
in the region.
We recognise that the number of Reproductive Health and
Childbirth commercial studies nationally is very limited and we
will seek to develop a strategy that strengthens links with
potential commercial partners
All Renal units in the region actively promoted Renal research studies that are suitable
for their patients. This includes a publication produced by a local Kidney Patient
Association produces includes research which covers 3 counties, posters in all of the
Renal units in the regions and research newsletters produced at some sites.
In 2014/15, we will identify a midwifery champion for the LCRN
We will identify and open suitable research studies in the
disease areas of asthma, CODP and pneumonia in the region
The Specialty has identified 2 leads with a research interest in
asthma and COPD (Prof Ian Pavord and Mona Bafadhel) who
will help us to increase our recruitment to these disorders and
we are aiming to identify and recruit more participants via
primary care
The number of commercial studies delivered in the region has risen from 0 in 13/14 to
2 in 14/15 and there are further studies in the pipeline. In addition, the LCRN is the 3rd
highest recruiting network to reproductive health commercial studies.
A midwifery champion is in post and has been able to attend the meetings held to date
and is focussing initially on ensuring there is networking and support of research
midwives based in DGHs who can often feel isolated. The midwifery champion played
a key role in the delivery of the recent Division 3 research network event.
Recruitment to Respiratory Studies in the region increased by 72% to 195 in 2014/15.
The above recruitment includes 55 recruits to Asthma and COPD studies.
Engagement has taken place with Prof Ian Pavord and Dr Mona Bafadhel who are
acting as PI and/or CI to three new studies within the Respiratory Disorders Specialty
with a focus on Asthma and COPD.
We are also supporting Dr Bafadhel’s primary care based studies by recruiting nurses
to work specifically on her studies in GP surgeries.
For our local population, this would translate to a recruitment
target of 440 patients.
1: The LCRN supported recruitment of 247 patients into RCT studies in the region in
2014/15; this exceeded the target recruitment into RCT studies of 218 patients.
Whilst, in total, 1000 patients have been recruited to stroke
studies YTD in 2013/14, this activity is skewed towards
observational studies with over 50% being to recruitment to one
particular study - OXVASC (UKCRN 4646).
2: Whilst the network has not led a Stroke commercial study in the region, clinical
leads across the region are supporting nationally adopted Stroke commercial studies.
Most recently, two sites in the region have been selected for the Navigate Esus study
(Milton Keynes & Wycombe), SOS Penumbra also successfully recruited at Wycombe.
The network will prioritise establishing RCT trials in research
active centres in the region, where and when portfolio availability
allows. Significant proportions of the existing RCT trials running
in the region have recently closed or are approaching their
closure date so the available portfolio of RCT studies actively
seeking new sites appears quite limited. The feasibility of
making a significant impact on this measure within a short time
frame may be limited.
3: With the exception of Heatherwood and Wexham Park Hospital (now part of Frimley
Health) all other hospitals in the region recruited patients into NIHR Stroke portfolio
studies, achieving the benchmark of 80% of local trust with acute stroke services.
Although the region does not have a HSRC, the region has supported hyper acute
stroke studies, SOS Penumbra and TICH2 were both supported within the network.
The network will work with local clinical leads to ensure that any
commercial studies that local leads are approached about are
signposted towards the NIHR adoption pathway. Any information
packs that the stroke network have provided to clinical leads to
facilitate this in the past will be used within the network.
16
CRN: Thames Valley and South Midlands Annual Report 2014-15
Specialty
Ref.
Objective
Measure
National
Target
LCRN actions to achieve objective(s)
Performance against plan
We also recognise that the number of commercial stroke studies
nationally is very limited and that the Specialty does not attract
significant levels of investment from the pharmaceutical industry
compared with other Specialties. Therefore, we will seek to
develop a strategy that strengthens links with potential
commercial partners.
Surgery
3
Increase the proportion of
NHS Trusts, providing acute
Stroke care, recruiting to
Stroke studies on the NIHR
CRN Portfolio
Proportion of NHS Trusts,
providing acute Stroke care,
recruiting participants into
Stroke studies on the NIHR
CRN Portfolio
80%
There are currently two NHS trusts that provide stroke services
in the region that do not participate in stroke studies at present.
We will work with local clinical leads and identify any studies that
may be suitable for these sites and provide resource to support
these studies where this is feasible.
4
Increase activity in NIHR CRN
Hyperacute Stroke Research
Centres
A: Number of patients recruited
to hyperacute Stroke
studies on the NIHR CRN
Portfolio in each NIHR CRN
Hyperacute Stroke
Research Centre (HSRC)
50
There are no hyperacute stroke research centres in the LCRN
region at present. We believe that TICH2 and ENCHANTED
may be in the process of looking for new sites – although we
understand that priority is normally given to regions with
designated hyperacute research centres. Nonetheless, as the
position on hyperacute studies become clearer we will work with
local clinical stroke teams in trusts with acute stroke services to
identify any studies that may be suitable for them as part of the
development objectives for the stroke work stream in the region.
B: Number of patients recruited
to complex hyperacute
Stroke studies on the NIHR
CRN Portfolio in each NIHR
CRN HSRC
15
There are no hyperacute stroke research centres in the LCRN
region at present. Nonetheless, we will consider complex
hyperacute studies on a case by case basis and work with
clinical stroke teams in trusts with acute stroke services to
identify any studies that may be suitable for these trusts as part
of the development objectives for the stroke work stream in the
region.
C: Number of HSRCs
recruiting to Stroke
commercial contract studies
on the NIHR CRN Portfolio
8
There are no currently no hyperacute stroke research centres in
the LCRN region although we are aware of two commercial
studies that are currently open to recruitment locally, albeit with
limited recruitment activity. The LCRN will work with local PIs to
identify any ways of increasing activity on these commercial
studies.
1
Increase the number of NHS
Trusts supporting Surgery
studies on the NIHR CRN
Portfolio
Proportion of acute NHS
Trusts recruiting patients into
Surgery studies on the NIHR
CRN Portfolio
75%
If co-adopted studies are included in this metric, the region
successfully recruited to studies in all acutes in 2013/14.
However, this metric would not have been met if it relates just to
studies that are led by the Surgery specialty and the region
needs to expand its portfolio in this area.
2
Increase the proportion of
surgery patients recruited into
Surgery studies on the NIHR
CRN Portfolio
Number of participants (per
100,000 surgical admissions)
recruited into Surgery studies
on the NIHR CRN Portfolio
50
This would translate into a recruitment target of 230 participants.
The region will work to increase the number of participants
recruited into Surgery studies to meet this objective.
Recruitment to Surgery Studies has remained very low. A number of factors that have
contributed to this poor performance have been identified including staff retention
issues. These include problems with space and working arrangements in Oxford and
we are in the process of setting up a Research Delivery Team (initially two research
nurses and a clinical trials practitioner) that will be centrally managed by the LCRN
and used as a flexible resource as needed – but with an initial focus on Surgery
studies. A steering group has also been set up to drive this forward and will meeting
monthly to review trials that this team will potentially take on. Thus, we aim to
significantly expand the portfolio of Surgery studies and increase recruitment to these
studies in 2015/6
17
CRN: Thames Valley and South Midlands Annual Report 2014-15
Table 3: LCRN’s achievement against the 2014-15 Operating Framework Compliance Indicators
Domain
Objective
1
A:
LCRN Management
Arrangements
Clinical Research Leads, Clinical Research Specialty Leads, Divisional
Research Delivery Managers, Cross-Cutting Team and Support Team
are in post
Information requested in
Annual Report Commentary
Commentary on LCRN Performance in 2014-15
Provide brief reflective
commentary on local
performance in 2014-15
The LCRN needed to appoint to a number of management vacancies in order to complete its core team
in line with the new national structure. By 31st March 2015, all RDM posts had been successfully filled.
All 6 Clinical Research Leads are in place.
The LCRN still needs to appoint 2 Clinical Research Specialty Lead positions (Age and Ageing and Oral
and Dental). We are currently working with CRN: Wessex to identity leadership for the Oral and Dental
portfolio since there is no Dental school in the region. The Clinical Lead for Division 5 will provide
leadership for Age and Ageing until an appointment can be made.
B:
LCRN leadership and management groups are established (LCRN
Executive Group, Clinical Research Leadership Group and Operational
Management Group)
Provide brief reflective
commentary on local
performance in 2014-15
All leadership and management groups have been established and hold regular meetings which are
minuted.
LCRN Executive Group
Met every c. 8 weeks in 2014/15 and plans to meet more frequently in 2015/16 to provide greater level
of oversight and scrutiny of the LCRN’s progress against objectives in the annual plan.
Clinical Research Leadership Group
Met on a quarterly basis in 2014/15. In addition, an annual meeting scheduled for all Clinical Research
Specialty leads, Clinical Research leads and Clinical/R&D leads in partner trusts for July 2015
Operational Management Group
Met every month throughout 2014/15
2
Research Delivery
A:
LCRN Partner organisations adhere to specified national systems and
Standard Operating Procedures in respect of research delivery
Provide brief commentary
reflecting on local performance
in 2014-15 in relation to:
 Adherence to National SOPs
for commercial service
delivery
 Contribution to the national
Study Support Service
programme
 Implementation of local
elements of the Study Support
Service
The industry team adhere to the national SOPs for the commercial service delivery.
With regards to the wider Study Support Service program, LCRN team members participate in several
working groups contributing to the development of national systems and SOPs. The Cross Divisional
and Support Services Manager is also the study support services link and sits on the national strategy
board for the Study Support Service. There is representation on the national AcoRD Implementation
Project Board and the Primary Care Working Group.
The local elements of the Study Support Service have been reviewed and have been discussed with
representatives of the R&D departments from other trusts within the region. The core RM&G team are
expected to transition into a core ‘Study Support Service’ providing services for the Chief Investigators
and central study teams. A study support and cost attribution manager is already in post - based on the
original lead network resource. Many study support services are already provided by the LCRN and
these are increasingly being used. Thus, the transition is envisaged as an extension of existing service
offerings rather than the launch of a new service with effect from 1st of July 2015.
Processes for the region will be brought into line with national guidance as soon as available.
Local elements for site level activities are being developed and will be split between divisional and trust
resource
B:
Timely processing of study wide and local reviews within the CSP
process (15 days respectively)
Provide brief reflective
commentary on local year to
date performance for 2014-152
The data below summarises our performance from CSP (ODP data not accurate) for full year
performance for study wide checks and NHS Permission.
The data below summarises our performance from CSP and ODP data for full year performance for
study wide checks and NHS Permission.
**HLO4 (2014/15 Q1-3) – ODP data n=52 number of studies in 14/15 Q1-3 n=45, 85.54% of studies meeting 40 days, n=7 studies over 40 days HLO4 (2014/15 Q1-4) - data extracted from CSP 2
For performance data please refer to the March 2015 LCRN Management Group report (on the Information Managers' portal or the vBIU) 18
CRN: Thames Valley and South Midlands Annual Report 2014-15
Domain
Objective
Information requested in
Annual Report Commentary
Commentary on LCRN Performance in 2014-15
n=66 number of studies in 14/15 Q1-4 n=16, 25.26% of studies meeting 40 days, n=50 studies over 40 days Study Wide (2014/15 Q1-4) (including eligibility process) n=107 number of studies completing study wide in 14/15 Q1-4 n= 83, 77.57% of studies meeting SW 15 days 10 days = Median of studies completing study wide in 14/15 Q1-4 *Study Wide (2014/15 Q1-4) (excluding eligibility process) n=97 number of studies completing study wide in 14/15 Q1-4 n= 84, 86.6% of studies meeting SW 15 days 9 days = Median of studies completing study wide in 14/15 Q1-4 NHS Permission (2014/15 Q1-4) n=392, number of NHS Permissions issued in 14/15 Q1-4 n=337, 85.97% of sites meeting local 15 days 7 days = Median of sites issuing NHS Permission in 14/15 Q1-4 The CSP process timelines for CRN: Thames Valley and South Midlands are exceeding the target of 15
days for study wide and local reviews, at 9 median days* and 7 median days, respectively. The local
year to date performance for 2014/15 is commendable in consideration of the transitional period for the
local networks. The study wide governance review have been completed within 15 calendar days for
86.6%* of studies and in the LCRN the local governance reviews have been completed within 15
calendar days for 85.97% of research sites, hence a high proportion of studies are processed in a timely
manner via CSP within the LCRN geography. It should be noted that, in common with other networks,
the LCRN has not been as successful in reducing the time taken to achieve NHS permission through
CSP for NIHR studies (HLO4), with only 25.26%** of the proportion of studies obtaining NHS
permission* within 40 calendar days (from receipt of a valid complete application) for 2014/15.
Actions have been identified to improve performance and LCRN core RM&G delivery staff will review
performance for all studies where the LCRN is the Lead. In addition, further development of the Study
Support Service will ensure a regular weekly review of the performance of participating sites issuing
NHS Permission within this high level objective.
Despite Q4 of 2014/15 being the busiest on record for the LCRN, we still maintained a median of 12
days for study wide reviews.
** There appears to be a discrepancy between how the HLO4 is calculated when comparing the
dashboard data within ODP (85.54% studies met HLO4) and the raw data from the CSP Reporting
Functionality within CSP Module (25.26% studies met HLO4). This has been reported to the CRN
Performance Team for further investigation.
C:
Support the delivery of the Government Research Priority of Dementia
Addressed through completion of Tables 1 & 2
3
Patient, Carer and Public
Involvement and
Engagement (PCPIE)
Promote research opportunities in line with the NHS Constitution for England,
including informing patients about research conducted within the LCRN and
actively involving and engaging patients, carers and the public in research
Provide brief reflective
commentary on local
performance in 2014-15 to
include examples of
methodologies employed to
understand patient experience
During the year, we 
Worked with local partner organisations to produce a map of local patient interest groups

Reviewed regional NHS trust websites for presence of research related information in
partnership with local patient groups for purpose of reporting to the LCRN Partnership Board

Produced a number of newsletters and some radio work highlighting research opportunities

Promoted the development of pilot programme to enable partnership of patient interested
groups to be embedded within study project teams to support research studies and provide
feedback through all stages of the research study cycle.

Discussed LCRN work at local patient group meetings

Promoted use of a single generic exit questionnaire for 2015/16
4
Continuous Improvement
Promote and sustain a culture of innovation and continuous improvement
across all areas of LCRN activity to optimise performance
Provide brief reflective
commentary on local
performance in 2014-15
A strong culture of innovation and continuous improvement exists. All divisions are operating projects
which are captured under the continuous improvement work stream. The region has participated
actively in green belt six sigma projects sending 3 participants to undertake projects in primary care,
RM&G and industry operations for site intelligence/site identification.
All projects undertaken locally are registered within the national database. A project manager was been
19
CRN: Thames Valley and South Midlands Annual Report 2014-15
Domain
Objective
Information requested in
Annual Report Commentary
Commentary on LCRN Performance in 2014-15
recruited with specific responsibility to support the continuous improvement agenda and promote
continuous improvement throughout the network.
5
Workforce Development
Develop and implement an LCRN Workforce development plan in
partnership with relevant stakeholders and other local learning providers
Provide brief reflective
commentary on local activities,
priorities and engagement in
2014-15
The CRN has a workforce development (WFD) lead, a deputy lead and 0.5 FTE admin resource and
dedicated budget line.
There is an active steering group, with membership from the Host trust, all partner trusts, each clinical
division, the cross-cutting network team and Oxford BRC/AHSN which met several times during
2014/15.
Our strategy is based on the Performance Operating Framework and drives our WFD activities. We aim
to be inclusive and offer opportunities for CRN and non-CRN funded staff working on portfolio studies.
During the year, we used the LCRN website and local newsletters to publicise WFD activities.
We also have an active group of GCP facilitators and wide pool of competent/trained facilitators to
deliver training across the region.
Local innovations that have been developed/delivered during 2014/15 include the following
Induction webinar which is hosted live by the CRN executive team and delivered each
month together with CRN wide induction pack

Good practice initiatives to overcoming barriers to recruitment, signposting document that
signposts staff to research resources and key contacts in the region

Team building for core network team and use of ‘Working in the CRN’, a values based
approach to deliver exercises

The development of research ask videos for research and clinical staff training (with PPIE
involvement in the development and production)
We have also piloted the Fundamentals of Clinical Research Nursing, and now have a 2015/16
programme of 2 day events.
We are planning to develop Fundamentals of Clinical Research for Non-nursing’ research posts, and roll
this out shortly.
Our CRN director is leading on PI education and engagement (including PI masterclass)
6
Financial Management
A:
LCRN Host and Partner organisations must meet minimum control
standards, as specified by the national CRN Coordinating Centre
Provide brief commentary
reflecting on local performance
in 2014-15
The LCRN ensures that partner organisations are fully aware of the CRN’s minimum control standards
with regard to financial management over CRN funds and there were no significant control issues in
2014/15. The LCRN adheres to all Host financial policies for expenses and procurement and financial
accounting cut off procedures.
The Chief Operating Officer (COO) and Resource Planning and Analysis Manager in the LCRN both
work closely with partner organisations and the Host R&D Finance department to ensure effective
management and control over the budget. Monthly meetings are held with R&D Finance and all invoices
are currently signed off by the COO.
We worked closely with partner organisations during the year, sharing proposed methodologies for
funding allocations widely with partners and agreeing the final submissions for each trust as part of our
quarterly financial processes.
B:
LCRN Host organisation must meet minimum requirements for the
scope of internal audit work, as specified by the national Coordinating
Centre
Provide brief commentary
reflecting on local performance
in 2014-15
If the LCRN has been able to
factor in an internal audit in
2014-153, provide a brief
commentary
An internal audit of the function was carried out by the Host trust internal auditors (KPMG) in February
and March 2015.
No significant issues were raised with the LCRN or the Host R&D finance department at the time of the
audit and the final audit report is currently awaited.
3
In light of the timing of the issuing of the associated guidance, this requirement has been extended through to 2015/16.
20
CRN: Thames Valley and South Midlands Annual Report 2014-15
Domain
Objective
7
LCRN Host and Partner organisations have access to the required
information systems and services
Information Systems
Information requested in
Annual Report Commentary
Provide confirmation that key
named systems are in place,
including:

LPMS systems are in place
as required

Provision of an LCRN
Service Desk function and
provide contact details

Access to NIHR Hub
systems and services,
Or describe steps being taken to
implement them and provide a
target delivery date.
Provide brief commentary
reflecting on local performance
in 2014-15 against the
remaining areas in section 13
(Information Systems) of the
NIHR CRN Operating
Framework
8
Communications
LCRN communications function and delivery plans in place, and budget line
identified
Provide a brief commentary
reflecting on local performance
in 2014-15 and on the LCRN’s
contribution to national NIHR /
CRN campaigns
Commentary on LCRN Performance in 2014-15
The LPMS system is under development. A bespoke system is being developed from an initial existing
system within the Host R&D department (RPM). All trusts have signed up to the new system and roll out
is expected early in 2015/16.
Meetings have been undertaken with the information Management Team supplying IT infrastructure for
the Host and a number of options identified for the operation of a Service Desk. A final decision will be
taken shortly with a revised target date for initial operation of 1st of August 2015.
All aspects of the Hub are being actively utilised within the network for example
Existing shared e-mail accounts have now been transferred to NIHR.

Industry and RM&G trackers now transferred to the Hub

Hub site now active

Drives available to all divisions and cross divisional team
We are aware of the need to undertake further steps to embed and fully utilise these new services and a
project plan with actions required and future initiatives is being finalised. Where possible systems and
operations of the Hub will be standardised across teams and divisions such as operation of e-mail, file
storage etc. whilst allowing appropriate variation to specific team requirements.
The CRN utilises national systems such as ODP and Commercial and industry reports to inform
business intelligence and provide information for both trusts and divisions.
We have led the development of a regional communications group inclusive of local partner
organisations, trusts and patient groups to coordinate regional research communications (among them
a radio campaign, research participant survey, website content).
We contributed to the National Patient Stories Campaign alongside our own awareness raising work,
focussing on health awareness days.
In addition we have
Produced training videos for clinicians (asking about research - various conditions)

Produced a Bi-annual network newsletter and monthly internal staff bulletins

3 patient representatives have been recruited to attend the Network’s Partnership Group meetings
During the year, we decided to increase the resource available to the communications, engagement and
PPIE work streams to support and lead the 2 x part time managers currently in post and we are
therefore currently in the process of appointing new lead manager. The role should be filled by August
2015 and will significantly enhance our ability to develop and deliver more ambitious PPIE and
communications work programmes.
9
Information Governance
LCRN Host and Partner organisations comply with CRN Information
Governance (IG) requirements
Report IG Toolkit 2014-15
version 12 scores for the LCRN
Host organisation and LCRN
Partner organisations and
confirm attainment of Level 2 or
above on all requirements, or
any exceptions which arise from
or impact on LCRN-funded
activities
The following IG Toolkit version 12 scores have been reported to us
OUHT 91%, level 2 on all requirements

BucksHT 80%, level 2 on all requirements

MKUHFT 84%, level 2 on all requirements

RBFT achieved Level 2 on 47 requirements. Only received a level 1 (95%) for training
requirements and as a result did not pass on this aspect

Berkshire Healthcare 66%, level 2 on all requirements

Oxford Health 82%, level 2 on all requirements
21
CRN: Thames Valley and South Midlands Annual Report 2014-15
Table 4: Host organisation’s achievement against the 2014-15 Host Performance Indicators
Domain
Objective
National CRNCC Approach
Reflective commentary on LCRN Host organisation Performance in 2014-15
1
Deliver effective leadership and management of the LCRN
Annual survey by the national CRN Coordinating Centre of all LCRN
Partners to be conducted post 2014-15 year-end (survey April-May
2015, first formal annual meetings to be arranged in September
2015);
The LCRN attended an informal meeting with CRN in February 2015 to discuss
progress and received very positive feedback. In particular, the LCRN was
commended on its growth in recruitment and the strength of the Workforce
Development Strategy.
Reviewing overall LCRN performance, through Performance Review
meetings with the national CRN Coordinating Centre.
The need to focus on growing commercial activity was also discussed together with
issues in recruiting and retaining research staff given the high cost of living locally.
LCRN Leadership and
Management
Within the LCRN, the COO and Clinical Directors meet weekly to discuss progress
and address issues and priority areas. The Operational Management Group met
every month and the Executive Group met every c. 8 weeks. The Clinical Research
Leadership Group met every 3 months. The frequency of the Executive Group
meetings will be increased in 2015/16 to provide additional scrutiny and focus on
delivery against the objectives as set down in the 2015/16 annual plan.
Key priorities for the LCRN remain
improving recruitment to Cancer studies

developing Primary Care

increasing commercial activity
During 2014/15, the LCRN has driven several initiatives to improve performance in
these areas and further actions are being implemented in 2015/16.
2
LCRN Research Delivery
Infrastructure
Deliver a responsive and flexible NHS support service that
meets the needs of researchers, funders and industry.
Annual survey by the national CRN Coordinating Centre of LCRN
service users to be conducted post 2014-15 year-end
The Study Support Service will operate within the cross divisional team with resources
both for commercial and non-commercial studies. Workshops have been held with
representatives from member trusts to look at structures for aspects of the local
delivery of the service from RM&G staff embedded within the member trusts.
Provision of the Study Support Service has also been discussed with finance
representatives from the host trust and Oxford Health.
3
Financial Management
Deliver robust financial management using appropriate tools
and guidance
Measured by percentage variance (allocation vs expenditure)
quarterly and year-end (target is 0%)4;
Measured by percentage of financial returns completed on time
5
(target is 100%) .
The LCRN has delivered against all the financial performance metrics and internal
controls as set down by the CRN and there is a high degree of oversight of the
LCRN’s activities by the COO and the Host R&D Finance function. Financial
management adheres to all Host policies and procedures and balances are fully
reconciled with member organisations on a regular basis including at the year-end
close.
The local performance data provided by national CRN Coordinating Centre indicates
Budget variance for Q1-Q3 2014-15 = 0%

Performance for LCRN Annual Plan 2014-15 and Q1-Q3 2014-15 returns = 100%
The Host R&D Finance team produces status reports each month. They meet with the
LCRN each month to review progress and discuss any issues and they are in regular
contact with partner organisations. A commentary on the LCRNs’ financial
performance is included in each of the quarterly financial returns submitted on the
online Finance tool.
4
Allocation of LCRN funding
Distribute LCRN funding equitably on the basis of NHS
support requirements
Comparison by the national CRN Coordinating Centre of 2014-15
main allocations vs. recruitment to be conducted following year-end
and once cleansed recruitment data is available
The LCRN does not operate a ‘pass through’ financial model but seeks to allocate
funds equitably based on actual need and pipeline requirements. For 2014/15,
requests for funding were sought from each of our trusts and Specialties, in a
standard format comprising details on posts currently funded, support for new posts,
details of current trust /Specialty structures and information on recruitment objectives
by study.
The LCRN then considered these submissions alongside a more analytical review of
performance in trusts/Specialties which took into account a number of metrics
4
5
Variances for Q1-Q3 2014-15 pre-populated by national CRN Coordinating Centre in commentary column of row 3
Performance for LCRN Annual Plan 2014-15 and Q1-Q3 2014-15 returns pre-populated by national CRN Coordinating Centre in commentary column of row 3 22
CRN: Thames Valley and South Midlands Annual Report 2014-15
Domain
Objective
National CRNCC Approach
Reflective commentary on LCRN Host organisation Performance in 2014-15
including, study numbers, weighted and un-weighted recruitment (including known
PIC activity and studies where recruitment numbers are not logged) both for 2013/14
and previous years, any known complexity facts, anticipated pipelines and
plans/potential for growth.
We also took into account the following key objectives
a need to deliver the CRN High Level Objectives

ensuring that we are only funding bona fide ‘service support cost’ activities and
that, where appropriate, research is also being supported with monies from other
funding streams – such as grant monies and commercial income

a focus on funding nursing and support staff who are directly involved in the
recruitment of patients to studies
5
LCRN Governance
(Host Board)
Ensure that the Host Board has visibility of LCRN business
and fulfils its agreed assurance role
Review of Host Board meeting minutes submitted in response to
request from the national CRN Coordinating Centre (April 2015)
The CEO made the OUHT Board aware of the CRN contract when the contract was
initially awarded. The corporate governance arrangements for the LCRN were
formally approved by the OUHT Board (May 2015). The paper submitted to the Board
included
Summary of the key elements of the Performance Operating framework

Responsibilities under the contract

key accountable staff

scheme of delegation and Host Board controls and assurance requirements

escalation process

details on Partnership Group
The requirements to approve the annual plan and the annual report are therefore now
incorporated into the Host’s assurance framework and approval of this annual report
will be tabled at the Board meeting on July 8th 2015. The 2015/16 annual plan was
approved by the Board at its meeting on May 13th 2015.
The OUHT Audit Committee agreed to include a review of the LCRN’s financial
controls in its 2014/15 audit plan. This was conducted during February and March
2015. No significant matters were raised with either the LCRN or the Host R&D
Finance Manager and the final report is currently awaited.
6
LCRN Governance
(Partner Engagement)
Ensure all LCRN Partners are engaged in the work of the
Partnership Group
Annual survey by the national CRN Coordinating Centre of all LCRN
Partners, to confirm Partner involvement, to be conducted April-May
2015;
Review of Partnership Group minutes, submitted in response to
request from the national CRN Coordinating Centre to confirm
Partner participation (April 2015).
During the year, the Clinical Directors and Chief Operating Officer met with the CEOs/
Medical Directors of each partner trust to discuss how to operate the new Partnership
Group to operate. The Partners requested that whilst some of the meetings should be
face to face, they would also welcome the use of teleconferencing for some meetings
in order to save travelling time. Therefore, the schedule for meetings in 2015/16 will
include both face to face and teleconference meetings.
It is acknowledged that this process of engagement did result in a delay to the
meetings being established and only 1 formal meeting was held in 2014/15
(November 24th 2014).
The Partnership Group is currently chaired by the CEO of the Host organisation who
is retiring shortly and a process is underway to identify a new Chair for the Group.
7
Management of Risk
Establish and maintain an assurance framework and risk
management system for the LCRN, including an escalation
process
Monitoring through the LCRN Annual Plan and Performance Review
meetings with the national CRN Coordinating Centre (first formal
annual meetings to be arranged in September 2015)
The corporate governance arrangements for the LCRN have been formally
documented and were approved by the OUHT Board (May 13th 2015). These contain
details of the Host’s responsibilities under the contract, key accountable staff, the
scheme of delegation and Host Board controls and assurance requirements and the
formal escalation process.
The LCRN adheres to the Host’s risk management policy and procedures and
assesses risks in accordance with the Host’s criteria. These were reviewed when the
annual plan for 2015/16 was submitted and will be updated quarterly throughout
2015/16.
A copy of the latest risk register for the LCRN has been included as Appendix 1 to the
report.
23
CRN: Thames Valley and South Midlands Annual Report 2014-15
Domain
Objective
National CRNCC Approach
Reflective commentary on LCRN Host organisation Performance in 2014-15
8
Ensure delivery of LCRN performance against the LCRN
Annual plan
Monitoring through Performance Review meetings with the national
CRN Coordinating Centre (first formal annual meetings to be
arranged in September 2015)
The LCRN attended an informal meeting with CRN in February 2015 to discuss
progress and received very positive feedback. A more formal review meeting with
CRN will be held later in the year.
Management of LCRN
Performance
During 2015/16, the COO and Clinical Directors met weekly to discuss progress.
Executive Group meetings were held every c.8 weeks in 2014/15 and focussed on
key issues and priorities. The frequency will be increased in 2015/16 to provide
additional scrutiny and focus on delivery against the objectives as set down in the
2015/16 annual plan.
9
Host Corporate Support
Services
Deliver high quality Corporate Support Services as specified
in the NIHR CRN Performance and Operating Framework
Feedback from the LCRN Leadership Team at Performance Review
meetings with the national CRN Coordinating Centre (first formal
annual meetings to be arranged in September 2015)
The Host organisation has provided the following Corporate Support Services during
the year in line with the Performance and Operating FrameworkOffice space
Initially the LCRN core team operated from 4 buildings owned by OUHT and Oxford
Health. They are now based within a single office on the Nuffield Orthopaedic
Centre site in Oxford with a small satellite office at the John Radcliffe Hospital. The
Host arranged for the new office space to be refurbished to a high standard.
Finance support
This is provided by the Host R&D Finance team which liaises on a regular basis
with the LCRN core team and manages the interface with the CRN online Finance
system and the CRN central finance team.
HR support
HR support is provide as required by the Host’s corporate division HR team
It Support
The Host provides IT Support in line with its standard systems arrangements and its
IT helpdesk facilities cover members of the core team
24
CRN: Thames Valley and South Midlands Annual Plan 2015‐16 Appendix 1: LCRN Risk Register NIHR Clinical Research Network Risk Register March 2015 Owner of LCRN Risk Register: V Woods, Chief Operating Officer, LCRN Updated: 24 February 2015 Next Review: May 2015 Scoring legend 1 2 3 4 5 Likelihood Over 12 months: Rare Over 12 months:
Unlikely Within 3 – 12 months: Possible Within 3 months:
Likely Within 3 months:
Almost certain Consequence Insignificant Minor Moderate Major Catastrophic Risk Score (on averaged
basis for all risks listed)
Risk Level >15 8 ‐ 14 4 ‐ 7 1 ‐ 3 Extreme Risk
High Risk Moderate Risk Low Risk Inherent (gross) # CRN1 Risk Description Uncertainty around requirements for new study support service as HRA introduced Likeli‐
Impact hood (1‐5) (1‐5) 4 3 Residual (net) Consequence of Failure to Manage Risk Activities to Reduce/Eliminate Risk (a) 12 Could be both operational and reputational risk to LCRN If a ‘quick start up’ approach is adopted by HRA before all systems/processes have been developed, there is a real risk of confusion for researchers 



Likeli‐
hood Impact (1‐5) (1‐5) Risk Control Score (b) (a‐b) Responsibility monitor new requirements closely and plan workloads well ahead, reviewing level of resource as necessary keep Executive Group updated on any issues work with CRN CC on new arrangements work closely with HRA local Champion (Janet Boothroyd) 4 2 8 4 Cross Divisional Manager re‐advertise roles if necessary advertise more widely than NHS jobs if required to improve quality of candidates applying for roles Work with Host trust on retention policies/enhancements 4 2 8 7 Cross Divisional Manager Could destabilise and demotivate work teams CRN2 Cannot recruit or retain good staff due to high cost of living and low unemployment in the region 5 3 15 Impact on resilience of LCRN Ineffective career planning Demotivating for existing staff due to work pressures 


25
CRN: Thames Valley and South Midlands Annual Plan 2015‐16 CRN3 Continuing complexity in metrics and on‐going differences between metrics for DH and CRN 5 3 15 Lack of LCRN buy in with trusts if focus on DH metrics and not CRN ones 


work with CRN CC on concerns continue to highlight at national meetings develop effective systems for collecting data locally (eg LPMS) to meet all requirements 4 2 8 7 Cross Divisional Manager 

work with CRN CC further work with local stakeholders (LAT, CCGs) 4 2 8 7 Cross Divisional Manager deliver primary care strategy Strengthen links with GP groups – especially outside Oxfordshire closer working with LAT 3 2 6 4 Clinical Lead/RDM for Division 5 better use of data to understand and performance manage improve processes for supporting follow up consider direct taskforce 3 2 6 4 Clinical Lead/RDM for Division 1 deliver industry strategy work collaboratively across the region with other NIHR funded bodies close working with Partnership Group better use of data to understand and performance manage hold regional industry conference 3 2 6 4 Cross Divisional Manager May reduce effectiveness of monitoring of performance against time to target and first patient visit Too much time diverted to debates on how performance is measured rather than focusing on problem solving CRN4 Cannot agree policy for ETC 5 3 15 Cannot run studies Reputational risk CRN5 Primary Care recruitment below national average 5 2 10 Not achieving potential in the Thames Valley & South Midlands region 

Not meeting national objectives 
Losing momentum on Primary Care research CRN6 Cancer recruitment below national average 5 2 10 Not achieving potential in the Thames Valley & South Midlands region Not meeting national objectives 


Losing momentum on Cancer research CRN7 Industry performance is below national average 5 2 10 Not achieving HLOs Not achieving potential in the Thames Valley & South Midlands region Not meeting other national objectives Reputational damage and missed opportunities 




Impact in terms of RCF funding which further limits ability to grow commercial portfolio 26
CRN: Thames Valley and South Midlands Annual Plan 2015‐16 CRN8 Ineffective implementation of Google platforms and hub 4 2 8 Lack of awareness of CRN activities 
Not using Hub to full potential or in line with national expectations 
implement action plan to develop hub working locally work with CRN CC on technical issues 3 2 6 2 Cross Divisional Manager hold meetings of LPMS Steering Group and Project Group as soon as CPMS implemented, agree scope of additional functionality required and build necessary interfaces asap 5 1 5 5 Chief Operating Officer make guidelines clear signal early what can and can’t be done more work to consider costings at study development stage so that realistic expectations and common understanding can be set very close operational management of budget
retain contingency fund if possible to address urgent requests closer work with OUH R&D Finance to develop stronger systems that incorporate all funding sources (BRC, RCF, commercial, Grant etc) in decision making 2 2 4 5 COO/RDMs/Cross Divisional Manager discuss plans for new chair at next meeting once in place, schedule meetings well in advance vary format to make meetings attractive and opportunities to showcase achievements 2 2 4 2 Chief Operating Officer work with OUH chief nurse on updating and co‐coordinating policies and approaches for attracting, retaining and developing research and clinical roles provide support through CRN workforce development initiatives 2 2 4 2 Chief Operating Officer 2 2 4 2 Chief Operating Officer Unable to access up to date information CRN9 LPMS implementation will over run into 2015/16 5 2 10 Will not meet CRN objectives Reputational risk 

CRN10 Requests for SSC funding on new studies will outstrip ability of CRN to commit financial support, particularly moving into 2015/16 3 3 9 Operational and Reputational risk Missed recruitment opportunities 





CRN11 Partnership Group meetings may not meet all CRN objectives 3 2 6 Difficulties in making meetings all quorate 
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Difficulties in scheduling 4 x meetings 
per year Chair is stepping down CRN12 Cannot fill posts or retain research staff in OUH due to fixed contract length whilst at same time there are trust concerns that availability of research posts in OUH may be impacting adversely on their ability to retain staff in clinical posts 3 2 6 CRN cannot attract or keep experienced staff 
Leads to disruptive staff turnover OUH cannot retain sufficient cover in clinical posts 
Policies for research staff and clinical staff are not in alignment CRN13 Insufficient space available at 3 2 6 Cannot run studies if no space so ‐raise at Executive Group meetings 27
CRN: Thames Valley and South Midlands Annual Plan 2015‐16 Churchill sites for research staff impacts on delivery of recruitment objectives ‐arrange meetings of all relevant stakeholders on Churchill site to find better solution Adverse impact on team morale ‐offer ‘hot desk’ space in network office at NOC Staff leave due to poor working conditions CRN14 Implications of LCRN policy not to fund Clinical Delivery PAs in 2015‐16 4 2 8 Clinician’s unable to source funding from other sources or embed in job plans Could impact upon morale Couple impact on study delivery ‐raise at Executive Group meetings 2 2 4 4 Chief Operating Officer ‐improve internal communications with Divisional RDMs and Clinical Research Leads to flag up and address potential issues at an early stage ‐explore solutions and best practice from other LCRNs 28
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