[PUBLIC ]
PAPER
[This will be input by
secretariat]
Report to the Meeting of the
Oxford Health NHS Foundation Trust
Board of Directors
July 2014
Research and Development Report
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Clinical Quality and Care
It is increasingly recognised that participation in research produces widespread benefits for
patients and, more generally, improvements in quality of care. Research active clinical
services are more likely both to generate and speed access to innovations in health care.
The high levels of quality assurance required in research governance and ethical approval
procedures can drive up the rigour and quality of routine clinical care. Research often
requires cutting edge scientific infrastructure – for example brain imaging facilities - which can
also be used for routine clinical care. There is also evidence that more academic clinical
organisations are more successful in effectively recruiting and retaining high quality staff.
Engagement in R&D activity can increase staff morale, help attract and protect resources and
improve the status and profile of a healthcare provider.
Networks and Collaborations
The Trust continues to significantly engage in research activity, particularly within the area of
mental health, where it is acknowledged we are in the top three nationally. The Trust is
remodelling its clinical services, including physical and integrated healthcare services. In
order to do this successfully, effective involvement in networks and collaborations is key.
There have been a number of major academically based NHS initiatives aimed at increasing
research productivity and accelerating the adoption and diffusion of innovation into clinical
practice including:

The creation of Academic Health Sciences Networks (AHSN), which followed the
publication of Innovation Health and Wealth. The Trust is closely involved in the
evolving Oxford AHSN which has brought a range of new opportunities. We have been
particularly active in driving forward a number of the new Clinical Networks (see
below).

The creation of Collaboration for Leadership in Applied Health Research and Care
(CLAHRC) centres. The Trust is the lead Trust for an Oxford CLAHRC (see below).

The creation of four Diagnostic Evidence Co-operatives (DEC) to improve the way
diseases are diagnosed. The Trust has been awarded one of the four.

The Oxford Academic Health Sciences Centre (AHSC). The Trust is a key partner (with
Oxford University Hospitals Trust; Oxford University & Oxford Brookes University).
National Institute for Health Research (NIHR) Networks
The NIHR infrastructure in England changed on the 1st April 2014. There were nine
coordinating centres and 102 local networks across England, which encompassed 25
Comprehensive Local Research Networks in addition to various topic specific networks for
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cancer; medicines for children; stroke; diabetes; primary care; dementias; and
neurodegenerative diseases and mental health. There was inconsistent coverage across the
country, with complex geographies.
There is now one coordinating centre and 15 local networks, with a simplified national
coverage across all therapy areas. The networks are responsible for the distribution of £280
million of NIHR funding per year and have boundary alignment with the AHSN areas. They
are considered the “research arm of the NHS” and are there to provide infrastructure needed
to undertake clinical research; recognize and reward research as part of the “core business”
of Trusts and its workforce; facilitate networks of research active clinicians; decrease or
alleviate bureaucracy burden; and deal with systemic blocks to research delivery. The high
level objectives include: doubling the number of participants recruited to portfolio studies;
increased commercial trial activity, recruitment of patients to time and target; making the NHS
the best place in the world to undertake clinical research; and to provide every patient the
opportunity to take part in research.
The Clinical Research Network (CRN) Thames Valley and South Midlands is within the
Oxford AHSN area and is hosted by Oxford University Hospitals NHS Trust, with anticipated
annual funding of £13 million. Each of the NIHR CRNs will now cover all therapy areas and
allow flexible deployment of resources. Each CRN supports six divisions:
Division 1:
Cancer
Division 2:
Diabetes, stroke, cardiovascular disease, metabolic and endocrine disorders,
renal disorders
Division 3:
Children, genetics, haematology, reproductive health and childbirth
Division 4:
Dementias and neurodegeneration, mental health, neurological disorders
Division 5:
Primary care, ageing, health services and delivery research, oral health and
dentistry, public health, musculoskeletal disorders, dermatology
Division 6:
Anaesthesia/peri-operative medicine and pain management, critical care,
injuries/emergencies,
surgery,
ears/nose/throat,
infectious
diseases/microbiology, ophthalmology, respiratory disorders, gastroenterology,
hepatology.
Research Governance
Following a meeting in February 2014 of the newly reformed R&D committee it was decided
that there should be two key R&D forums within the Trust. An R&D Governance Committee
has therefore been established to address governance issues. Agenda items will consist of
finance, staffing, current studies and recruitment, communications, CRIS, PPI and the
reporting of sub group meetings (CRF Board, Finance, Study Review Panel, Monitoring and
Auditing, CRF Users). The committee with meet quarterly, with representation including
Director of R&D, Deputy Medical Director, Head of R&D, Clinical Lead for CRF, Research
Governance Manager, Head of Information Governance, Deputy Director of Nursing, Head of
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R&D Finance, Contracts/legal lead, Primary Care Lead and Clinical Leads for Trust Divisions
(being agreed). The minutes of meetings will go to the Clinical Effectiveness Committee
(QuIC). The second new forum, the R&D Strategy Forum, will meet two to three times per
year to discuss strategic R&D issues both within the organization and externally in
collaboration with various other organisations. The R&D Strategy Forum membership is
Director of R&D, Head of R&D, Clinical Lead for CRF and all members of the Trust Executive
Board. Both of the new forums have already started meeting.
Studies and Participant Recruitment
The Trust currently hosts a number of different research studies, from small student projects
to complex commercially sponsored CTIMPs.
The table below shows current research activity ongoing within the Trust. The figures are
transient due to projects starting and completing at different times.
As at:
of
of Total,
of Total
Total
of Total
of Total,
of
Portfolio
of Total
Clinical
of Total of Total of Total
NIHR
26/06/2014 16:46 Number of
OHFT
PCT/OHFT
Portfolio via CSP
Students Psychology Funded
PICs
CTIMPs
UKCRN
studies
sponsored
new
via CSP
OHFT
Trainees
Portfolio
Lead
Open
112
23
27
12
75
15
11
3
68
62
21
Awaiting approval
13
2
3
0
5
1
2
0
7
7
0
Key: PIC – Participant identification centre
CTIMP – Clinical Trial of Investigational Medicinal Product
NIHR – National Institute for Health Research
UKCRN – UK Clinical Research Network
CSP – Coordinated System for gaining NHS Permission
Since the last report there has been an increase in the number of studies ongoing within the
organisation from 91 to 112. The average is transient and around 100 studies. The number
of NIHR portfolio adopted studies has increased during the last six months from 59 to 68; the
Trust is the lead site for 21 or these studies, a small decrease over the past six months.
The number of participants (patients, carers, staff etc) recruited to studies ongoing within the
Trust is shown in the table below:
All OHFT Site Studies - Recruitment
Portfolio
Nonportfolio
2013/2014
2010/2011
2011/2012
2012/2013
1919*
2303
1822
2763
77**
53**
359
780
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Key:
* because of previous years' inaccuracies this may be higher than actual
** incomplete return
Although the recruitment to portfolio studies has increased over the last 12 months and
Oxford Health NHS FT is the top recruiter nationally for mental health studies there needs to
be consideration for succession planning as some of the studies currently on the portfolio
recruit significant numbers and when complete could pose a risk to the figures as, at the
moment, there are no large recruiting studies are in the pipeline. It is hoped that the new
Research Implementation Manager will develop and implement a strategy to increase
participant recruitment to all research studies throughout the Trust. The post will be
supported by five research assistant posts situated within clinical teams throughout the Trust
NIHR Metrics and Targets
NHS organisations are expected to provide the NIHR with quarterly Performance Initiation
and Delivery (PID) reports, detailing the number of studies that recruit the first participant into
a clinical trial within 70 days of the organisation receiving a valid research application 1 and the
number of studies recruiting the expected number of participants (time to target). These
metrics may affect NIHR funding, with terms and conditions being incorporated into new
contractual agreements for infrastructure and grant funding.
Researchers are expected to inform the R&D department of the number of participants
recruited to their study, in line with the NHS permission. This data will inform the PID reports
that are compiled and published nationally every quarter. Consistent failure by Trusts to meet
these targets may result in a reduction of up to 5% of Research Capability Funding to NHS
organisations.
The table below shows the number of studies initiating research (70 day benchmark) over the
last 18 months.
Performance in Initiating CTs
Quarter
NHS Permission granted
within the period
Number of
studies with
valid research
application
Number of studies
that recruited 1st
patient within 70
days
Percentage of studies that
recruited 1st patient within
70 days
3 – 2012/13
1 Jan 2012 to 31 Dec 2012
12
4
33%
4 – 2012/13
1 Apr 2012 to 31 Mar 2013
12
3
25%
1 – 2013/14
1 Jul 2012 to 30 Jun 2013
12
8
67%
1
A valid research application is a complete research application that has been received by the NHS organisation
following its submission via the Integrated Research Application System (IRAS) that enables review by other
agencies (including, but not limited to Research Ethics Committee and MHRA approval) to be conducted in
parallel with the work on NHS permission by the contractor. For studies going through the NIHR Coordinated
System for gaining NHS Permission (CSP) this will include a valid site specific information ford (SSI) and local
associated documents as detailed on the IRAS checklist. Non CSP studies are also required to submit a valid
application for both study wide and local reviews as detailed on the IRAS checklist.
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2 – 2013/14
1 Oct 2012 to 30 Sept 2013
11
8
73%
3 – 2013/14
1 Jan 2013 to 31 Dec 2013
12
9
75%
4 – 2013/14
1 Apr 2013 to 31 Mar 2014
12
9
75%
The table below shows the time to target for research studies over the last 18 months
Performance in Delivering Commercial CTs
Quarter
NHS Permission granted
within the period
Number of
studies
listed
Number of
studies not
met target
Number of
studies met
target
Number of studies
still open to
recruitment
3 – 2012/13
1 Jan 2012 to 31 Dec 2012
7
2
0
5
4 – 2012/13
1 Apr 2012 to 31 Mar 2013
8
2
0
6
1 – 2013/14
1 Jul 2012 to 30 Jun 2013
8
4*
0
4
2 – 2013/14
1 Oct 2012 to 30 Sept 2013
7
4**
1
2
3 – 2013/14
1 Jan 2013 to 31 Dec 2013
7
3
1
3
4 – 2013/14
1 Apr 2013 to 31 Mar 2014
7
3
1
3
* 2 studies withdrawn by sponsor, 2 did not meet target and are closed to recruitment
**1 study withdrawn by sponsor, 3 did not meet the target and are closed to recruitment
Over the past year the R&D department have been endeavoring to improve performance in
these metrics by putting measures in place to ensure that researchers are “research ready” to
start their study when they submit their SSI forms and that they have realistically estimated
the number of participants that can be recruited to studies. The R&D department has worked
hard to liaise and support researchers, from both non-commercial and commercial sectors, to
ensure clear communications and that appropriate processes are followed. More work is
required and this is to be addressed at the R&D Strategy Forum in terms of further
embedding research into routine clinical practice.
Recent Research Project Develoments
Following the successful undertaking of two commercial studies within the CRF on behalf of
an external collaborator in the field of experimental medicine, P1Vital, the CRF has recently
opened a third study. This study, in an area of experimental research, has been adopted onto
the NIHR portfolio and will contribute to our recruitment figures.
ReD-KITE: Resistant Depression - Ketamine Infusion Trial Evaluation: a phase I, dose
escalation, safety study has closed to recruitment and data has been analysed to determine
the safety profile of repeated doses of ketamine infusions and to gain preliminary efficacy
data. The data was published in April 2014
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A number of studies are ongoing within the field of dementia, in support of the government
initiative to tackle the condition.
NIHR Oxford cognitive health Clinical Research Facility (CRF)
The CRF is a joint partnership between Oxford Health NHS FT, Oxford University Hospitals
NHS Trust and the University of Oxford. The annual return required by the NIHR for the CRF
award that flows through OUHT was submitted on 12th June 2014. The reports details study
activity across the four sites of the NIHR CRF (Warneford CRF, Oxford Centre for Anxiety
Disorders and Trauma (OxCADAT), the Oxford Cognitive Neuropsychology Centre (CNC)
and Charles Wolfson Clinical Neuroscience Facility). During 2013/2014 there were 19 studies
that were supported by NIHR Oxford cognitive health CRF across the different sites. There
was a reported occupancy of 56% based on actual half day units (rather than hours), an
increased from last year (40%), with 4567 outpatient visits, 147 day patient visits, 51
outpatient and 2943 telephone visits. There were seven publications as a result of the NIHR
infrastructure funding stream.
Finance
The Trust receives R&D funding from a number of different sources, primarily derived from:



The National Institute for Health Research (NIHR)
Clinical Research Network: Thames Valley and South Midlands (CRN)
Non-NIHR and Commercial Income
The type of income provided by these organisations is shown below. The NIHR and CRN
tables reflect the FY15 budgets with the Non-NIHR \ Commercial income table reflecting
actuals at the end of the first 2 months of FY15.
National Institute for Health Research (NIHR)
Type of income
FY15 Budget (£k)
Comments
Study (lead and subcontracted site)
1,552
To fund successful grant applications (a full list of currently active
studies is shown in Appendix A)
RCF
1,202
(see below)
CRF
717
CLAHRC
1,250
Total
4,721
Infrastructure funding for NIHR studies taking place within CRF
(see below)
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Research Capability Funding (RCF)
Research active NHS organisations receive RCF to enable them to meet some, or all, of the
research-related component of the salary of their researchers and research support staff
working on clinical and applied health research, where that component is not already provided
by another funding source
The annual RCF allocation combines a percentage of the NIHR funding received in the
previous calendar year with an allowance for each Senior Investigator associated with Trust.
In FY15 the Trust will be running two schemes, one for RCF generated from Department of
Psychiatry and Trust based investigators and a new scheme for RCF generated by
Department of Primary Care investigators. The Department of Psychiatry and Trust allocation
has increased by £92k compared to FY13 due to two additional SI awards (£150k, Charles
Vincent and Simon Lovestone). This increase was partially off-set by reduced study related
RCF (£58k).
Senior Investigators (SI)
FY14 Department of
Psychiatry \ Trust
FY15 Department of
Psychiatry \ Trust
FY15 Department of
Primary Care
Keith Hawton, Guy
Goodwin, John Geddes,
David Clarke, Alastair Gray
Keith Hawton, Guy Goodwin,
John Geddes, David Clarke,
Alastair Gray, Charles
Vincent, Simon Lovestone
Sue Ziebland
£0.375m
£0.525m
SI Funding (£75k)
Applicable Study Income
£1,592m
£1,338m
£.072m
Rate
0.405
0.439
0.20 ##
FY15
Total
£0.075m
£0.600m
Study Related RCF
£0.645m
£0.587m
£0.015m
£0.602m
Total RCF
£1,020m
£1,112m
£0.090m
£1,202m
## The DEC study in seen as a Centre and attracts a different RCF weighting
FY14 RCF
The table below shows the categories to which the FY14 RCF was allocated; it also shows
where the funding was generated and allocated between the Trust and University.
FY14 RCF (£k)
FY14 Award (Based on employing organisation)
Trust
University
Total
358
662
1020
(80)
(340)
(420)
Commitments by RCF category
The research-related component of an NIHR Faculty member’s salary, which is
not covered by other funding sources
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Meeting the cost of the time of Faculty members in preparing grant proposals
(124)
(65)
(189)
The research-related time of NHS-employed scientific, administrative and
secretarial staff who support Faculty members in their NIHR-related work
(78)
(247)
(325)
Accommodation costs, finance management costs, and human resource
management cost incurred in hosting NIHR-funded research
(86)
0
(86)
Total
(368)
(652)
(1,020)
The use and allocation of RCF is reviewed on a regular basis by the Director of R&D and the
Head of R&D Finance before approval by the R&D Governance Committee. In recent years
the drive has been to use RCF strategically for the benefit of research across the Trust, this
will continue in FY15 but, in addition, individuals were recently invited to apply for RCF to
support potential research activities. A panel met in May 2014 and agreed to fund the
following 4 applications at a cost of £79k.
Applicant
Position
Support Requested
Jane
Fossey
Associate Director of Psychological Services, Oxford Health
Assistant Psychologist/Research
Assistant
Andrew
Molodynski
Consultant Psychiatrist, Oxford Health & Honorary Clinical
Senior Lecturer, Oxford University Department of Psychiatry
Research assistant
Clare
Mackay
Oxford Dementia & Ageing Research (OxDARE) Co-ordinator
& Senior Research Fellow
Oxford Dementia and Ageing
Research (OxDARE) administrator
Maria Turri
Senior Clinical Research Fellow- University of Oxford &
Honorary Consultant Psychiatrist- Oxford Health
One session per week for 6 months
£
£27k
£9k
£35k
£8k
Clinical Research Facility (CRF)
The CRF reporting is split between NIHR and non-NIHR due to its origins and funding
sources. On the Warneford site the CRF operates as one unit containing 8 clinical rooms,
pharmacy, a meeting room and associated office space. The NIHR CRF encompasses
activities taking place at the Department of Experimental Psychology (OxCADAT and
OxCNC) and the Charles Wolfson Clinical Neuroscience Facility at the John Radcliffe
Hospital as well as those on the Warneford site.
Funding for the unit comes from the NIHR, CLRN and Commercial income. The FY15 budget
is detailed in the table below.
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FY15 Budget
Expenditure
(954)
NIHR Funding #
Funding in place until Mar 2017
717
CLRN Funding #
Funding allocated each year as part of the annual CLRN budget process
204
Budgeted Non-NIHR Income Target
93
Total Budget Income
1,014
Budgeted contribution to overheads
60
Margin % after recover of Direct, Accommodation and Finance Costs
6%
# The NIHR and CLRN require annual returns detailing the use of their funding.
Commercial price negotiations involve the Head of R&D and the Head of R&D Finance with
the final sign-off governed by authorisation limits agreed by the Director of Finance.
Clinical Research Network: Thames Valley and South Midlands (CRN)
Type
FY15
Budget (£k)
Comments
Mental Health \ R&D
340
Trust Governance and support staff and research active individuals within
the Trust
Clinical Research Facility (CRF)
374
Medical and nursing staff employed within the CRF
DeNDRoN (CRN Division 4)
245
CRN:TV SM Division 4 staff employed by the Trust
Network Staff Hosted by OH
262
CRN Network staff employed by the Trust
Community Staff
87
Community Research Nurses employed by the Trust
Thames Valley Primary Care
288
Thames Valley Primary Care Governance and support staff employed by
the Trust
Total
1,596
Non-NIHR (Commercial) Research Study Income
The table below shows research income reported from non-NIHR studies ongoing within the
CRF during the first 2 months of FY15.
Study
FLASHYLYTE RO4917838 in stable patients with persistent,
predominant negative symptoms of schizophrenia treated with
antipsychotics - Protocol No. NN25310
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Sponsor/Clinical
Research
Organisation
£k
Funding
Roche
4
Industry
Contract
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Long-term safety and efficacy of ABT-126 in subjects with
schizophrenia: a double blind extension study for subjects
completing study M10-855
AbbVie
Stem cells for Biological Assays of Novel drugs and predictive
toxicology (STEMBANCC)
University of Oxford
A randomised, double-blind, placebo- controlled, phase 3 study
to evaluate the efficacy and safety of once a day, TAK-375
(Ramelteon) tablet for sublingual administration (TAK-375SL
tablet) 0.1mg and 0.4mg as an adjunctive therapy in the
treatment of acute depressive episodes associated with bipolar 1
disorder in adult subjects (TAK_301)
Takeda
TOTAL
2
Industry
Contract
9
NonCommercial
1
Industry
Contract
16
A full list of currently active studies is shown in Appendix A.
R&D related Pharmacy Income
The CLRN (via R&D) fund posts within the Pharmacy Department who work on Research
studies and generate income (at the end of period 2 no income was reflected in the
accounts).
Financial Challenges
The main financial challenges for R&D are:
1. Contribution to Overheads
The budgeted contribution to overheads has remained static over the past few years.
This will become a cost pressure as the studies which contain generous overhead
allowances start to come to an end and the flexibility within R&D funding in relation to
overheads which existed in previous years reduces due to tighter reporting
requirements. Overheads from new studies are expected to be covered by a more
modest allocation via RCF.
2. Study Report and Publication dates
A number of studies have or will come to an end between Oct 14 and Mar 15 and their
NIHR contracts allow the withholding of final payments until reports are produced and
published. The effect of this is that costs will be incurred in one year but not recovered
until a future year. Last year an agreement was gained from the DoH to fund this from
RCF allowing the final payment to be released in the following year on the condition
that the funding is used for staff. The effect of this will be between £137k and £286k.
3. Maintaining the balance between:
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
Using the funding within the guidelines provided by the various funding
organisations particularly in relation to contributions to overheads

Remaining competitive in terms of commercial pricing

Managing the Trust expectations in terms of contributing to the EBITDA margin
The Head of R&D Finance and the Director of Finance are considering these requirements,
often on a study by study basis.
Pipeline Reports and Study Review Panel
The process for capturing, reviewing and monitoring study application is outlined below:




Initial meeting between the Investigator, Head of R&D Finance and Head of R&D
Documentation in the Pipeline Report (extracts below)
Formal review by the study review panel (Head of R&D, Head of R&D Finance, R&D
Clinical Lead, Lead R&D Nurse, Research Governance Manager)
Recommendations to the monthly R&D Senior Management Team Meeting
Pipeline Report (Commercial Activities)
Investigator
Study Description
Funder
Rupert McShane
ACE inhibitor for Prodromal AD
PARAXEL
John Geddes
Alzheimer’s disease development program of masitinib PHASE 1
AB Science -
John Geddes
Alzheimer’s disease development program of masitinib PHASE 3
AB Science -
Rohan Van Der Putt
Moderate Alzheimer’s
PFIZER \ ICON
Pipeline Report (Non-Commercial Activities)
Investigator
Study Description
Funder
Carol Bannister
ELAD
4 Different funders
Rohan Van Der Putt
AFFECT - Vascular Dementia
British Heart Foundation
John Geddes
Glutathione Study (Oxtext Blood Samples)
NIHR
Susannah Murphy \ Kia Nobra
Eye Tracking
NIHR funded via BRC
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Tony James
Adolescent Psychosis Stem Cell project
Tbc
Belinda Lennox
PPiP study (CRN ID 13692)
MCR
Daniel Freeman
'The evaluation of mechanisms and outcomes of a novel digital
reasoning intervention for persecutory delusions
EME
John Geddes
European Long-acting Antipsychotics in Schizophrenia Trial (EULAST)
EU
Paul Aveyard
Phase 3 trial looking at the use of cytosine in smoking cessation
tbc
Alison Baird
Circadian gene expression in AD study
tbc
Belinda Lennox
Dermatology Related Study
tbc
Submitted Applications (Non-Commercial)
Investigator
Study Description
£
Duration
Funder
Paul Stallard
A randomised controlled trial of Think Feel Do, a
computerised cognitive behaviour therapy programme for
children with mild/moderate emotional problems
£350k
2.5yrs
NIHR - RfPB
Dr Veronika Williams
Delivering support for self-management of dyspnoea-related
anxiety in Chronic Obstructive Pulmonary Disease using a
digital health platform.
£345k
2yrs
NIHR - RfPB
Paul Stallard
HTA outline for a trial of online interventions in the
prevention of depression
£2m
44mths
HTA
Simon Lovestone
Lithium Study
Alzheimer’s UK
Andrew Molodynski
Coercion Study extension
Tony James
DBT project
NIHR
EME
(MRC \ NIHR)
Collaboration in Leadership in Applied Health Research and Care (CLAHRC)
In January 2014 the Trust began receiving funding from the NIHR in relation to the CLAHRC
which is led by Professor Richard Hobbs from the University of Oxford Department of Primary
Care.
Governance Structure
The CLAHRC Governance Structure was agreed at the June 2014 Management Board
(shown below). The voting membership of the Management Board includes Mr Stuart Bell
(Chair) and Dr Clive Meux. The Head of R&D Finance attends as a non-voting member and is
part of the Executive.
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NIHR
Oxford Health NHS FT Board of
Directors
CLAHRC Management
Board
Stuart Bell CBE
BRC; BRU; DEC
AHSN; AHSC
Independent Scientific
Advisory Group
Stakeholder Working
Group
CLAHRC Executive
Professor Richard Hobbs
Early
Intervention &
Service
Redesign
Professor John
Geddes
Health
Behaviours
Professor Sallie
Lamb
Patient
Experience &
PROMS
Professor Ray
Fitzpatrick
SelfManagement &
Chronic Disease
Professor
Richard
McManus
MedicalPsychiatric
Comorbidities
Professor
Michael Sharpe
CLAHRC THEMES
CLAHRC Budgets
Budgets have been approved and released to the Theme Leads for the first 2 ¼ years ending
March 2016. It is planned that there will be a mid-term review by the Executive and
Management Board before budgets are released for the final 2 ¾ years.
Budget By Theme (£k)
Theme
Lead
Better Management of
Psychiatric comorbidities
Health Behaviour and
2013/14
(3 mths)
2014/15
2015/16
2016/17
2017/18
2018/19
(9 mths)
Total
Prof. Mike
Sharpe
14
185
370
373
369
274
1,585
Prof. Sarah
38
180
336
331
342
278
1,505
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Behavioural Interventions
Lamb
Early Intervention and
Service Innovation
Prof. John
Geddes
16
217
318
412
348
278
1,589
Patient Self-Management
(Chronic Disease)
Prof. Richard
McManus
46
295
380
321
331
209
1,582
Patient experience and
PROMS
Prof. Ray
Fitzpatrick
55
216
346
304
301
232
1,454
Central and Support Costs
81
157
250
259
309
229
1,285
Total
250
1,250
2,000
2,000
2,000
1,500
9,000
Matched Funding
A fundamental requirement of the CLAHRC is the need for additional matched funding from
other sources at least to the level of NIHR funding awarded. This funding needs to be
dedicated to supporting the proposed themes of research, implementation or a mix of both.
Identification of Matched Funding is an on-going process involving the CLAHRC Manager and
the Head of R&D Finance. The currently identified amounts of Matched Funding are shown
within the table below.
Matched Funding (£k)
Identified
2013/14
(3 mths)
524
To be Identified
2014/15
2015/16
2016/17
2017/18
2018/19
Total
(9 mths)
2,079
-
2,008
1,938
1,925
1,299
9,773
69
144
150
308
671
Total
524
2,079
2,077
2,082
2,075
1,607
10,444
Application
519
2,075
2,077
2,078
2,075
1,607
10,431
6
4
-
4
-
-
16
Variance
Oxford Academic Health Science Network (AHSN)
Oxford Health is hosting three of the 9 OAHSN Clinical Networks. These are Dementia; Early
Intervention in Mental Health; and Anxiety and Depression (detailed below).
Although the OASHN is seen as a clinical development, rather than primarily research related
activity, it is combined with R&D when reported in the Finance report to the Board, therefore
the following details are included for information
Network
Lead
Projects
15
Total
End Date
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Award
Dementia
Dr Rupert
McShane
Early
Intervention
in MH
Dr Belinda
Lennox
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
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Anxiety &
Depression
Prof David Clark

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Unwarranted clinical variation
Data capture systems
Development of drink as a potential
medical food with a dementia
indication
Reduced variation in care
Increase recruitment to Research
studies
Enhancing care continuity and
extending the model of early
intervention
Agreeing a schedule of clinical
assessments and criteria for EIS
Understanding outcome variability
Supporting local service innovation &
disseminating successes throughout
the region
£270k
June
2015
£210k
June
2015
£220k
Oct 2015
Estates
The Trust R&D Department, including the CRF, is based at the Warneford hospital site. The
CRF is now fully operational and eight research rooms are open for researchers to utilise.
Discussions are ongoing to be able to reunite
the R&D department, currently based within three locations across the Warneford site to two
areas so that there is easy access between the office space and CRF.
The Department of Psychiatry in the University of Oxford, has now secured funding and is
working towards installing an MRI scanner in the Oxford Centre for Human Brain Activity
(OHBA) which, in combination with the existing magnetoencephalography (MEG) scanner
and the technical and scientific expertise in the FMRIB facility, will give leading edge scientific
and clinical imaging capacity on the Warneford site. This is expected to take place within the
next 12 to 18 months
Staffing
The last six months has seen a complete restructuring of the R&D department, including the
introduction of a Senior Management Team (SMT) to define the reporting structures. The
SMT consists of John Geddes as Director of R&D, Emma Stratful as Head of R&D, Belinda
Lennox as Deputy Director of R&D and Networks, Bill Wells as Head of R&D Finance,
Victoria Rush as Research Governance Manager, Cindy Whitbread as Lead R&D Nurse and
CRF Matron and Mary Jane Attenburrow as Medical Lead. This is shown in the
organisational structure below:
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Director of R&D
John Geddes
Head of R&D
Emma Stratful
Deputy Director of
R&D and Networks
Belinda Lennox
CLAHRC Manager
Alex Gardiner
Head of R&D
Finance
Bill Wells
Finance Support
Nick Raven
PC R&D Manager
Julie Barker
Research Governance
Manager
Victoria Rush
Research Support
Facilitator (C&F)
John Hiene
R&D Lead Nurse
and CRF Matron
Cindy Whitbread
Senior Research
Nurse
Vacant
Research Governance
Facilitator
Claire Potter
Research Nurse
Rhonda Cowie
R&D Administrator
Jana Safarikova
Research Nurse
Vacant
Research
Practitioner
Helen Jones
Clinical Lead
Mary Jane
Attenburrow
Research Implementation
Manager
Bobbie Sanghera
CRF Medics
Andreas Cipriani
Katy Smith
Maria Turri
Elisa Favaron
Research Assistants
(Early Intervention
Adult Clinical
Vacant x7
Research
Practitioner
Rowena Johns
Research Nurse
Kevin Meek
Research Health
Care Assistant
Jithen Benjamin
CRF Receptionist
Val Paulley
PC – primary care
C&F – Children and Family Community Services
Following the departure of the Research Governance Manager in December 2013, a member
of the R&D department (Jen Lawson) took on a six month secondment to ensure study
governance within the Trust could continue until a permanent replacement could be found.
This was an exciting opportunity for this individual and provided her with valuable experience
before she accepted a new role at the University working with Professor Simon Lovestone.
Victoria Rush joined the R&D department at the beginning of June as the permanent
Research Governance Manager. The funding for Jen Lawson’s post has now been
strategically redeployed to recruit a senior research nurse to lead the day-to-day activity of the
CRF and is currently out to advert. It is envisaged that this senior post will support the Lead
R&D Nurse and provide an opportunity for greater expansion of the research delivery team.
R&D have undertaken two rounds of advertising and interviewing for the Research
Implementation Manager post, to lead on the recruitment strategy within the Trust. On both
occasions no suitable candidates were identified. In April 2014, Bobbie Sanghera, a research
nurse within the R&D department started a 12 month secondment into the post.
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Additional R&D department members that have joined the team within the last two months or
will do so over the next four weeks include:
Claire Potter – Research Governance Facilitator (replacement post)
Jana Safarikova – R&D Administrator (Maternity leave cover)
John Hiene – Research Support Facilitator (New post funded by Children and Families)
Jithen Benjamin – Research Health Care Assistant (new post funded by R&D)
Kevin Meek – Research Nurse (new post funded by R&D)
2 Research Assistants for Early Intervention Services (NIHR funded, due to start in August)
In addition to the Senior Research Nurse that is currently being advertised other posts that
are currently vacant include:
5 Research Assistants for AHMT services (funded by clinical services)
2 Research Nurses (one is a replacement post, for Rhonda Cowie who is due to leave at the
end of July and the other is a new post)
Funding from OUH RCF generated by the NIHR CRF funding has been secured to fund a
research nurse to support activity at Charles Wolfson Clinical Neuroscience Facility.
Interviews were held in May 2014, but no candidates were appointable
Communications
The CRF hosted successful open day on 20th May 2014 to coincide with International Clinical
Trials Day. Throughout the day there were presentations from researchers and research
participants in addition to more general talks.
The NIHR CRF internet pages are now live. Work is continuing with the Trust R&D website,
but resource and expertise are limited. Suggestions have been made that the R&D
department contributes one day a week to the Trust communications to support this.
Author and Title: Professor John Geddes, Emma Stratful & Dr Clive Meux
Lead Executive Director: Dr Clive Meux
18
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1. A risk assessment has been undertaken around the legal issues that this paper presents and there are
no issues that need to be referred to the Trust Solicitors.
2. This paper (including all appendices) has been assessed against the Freedom of Information Act and
the following applies:

THIS PAPER MAY BE PUBLISHED UNDER FOI
3. This paper provides assurance and evidence against various Care Quality Commission Outcomes
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Appendix A
Non-Commercial funded studies
Study
Funder
End Date
Value
Electroconvulcive therapy: a qualitative study of the experiences of patients
and their carers ( healthtalkonline )
NIHR
31/12/2014
£246,656
Aripiprazole treatment for antipsychotic induced hyperprolactinaemia in young
patients with severe mental illness and learning disabilities
NIHR
28/02/2015
£201,626
Development and evaluation of SMS-based monitoring and management
service for people with bipolar disorder
NIHR
31/12/2014
£1,660,037
Coercion in mental health. Patterns and prevalence of coercion in mental
health care and a trial of the effectiveness & costs of Supervised Community
Treatment orders
NIHR
31/07/2014
£2,072,032
An Optimised Person Centred Intervention to Improve Mental Health and
Reduce antiphychotic amongst people with Dementia in Care Homes
NIHR
31/03/2015
£2,042,199
Friends
NIHR
31/12/2014
£1,306,805
A multi-centre programme of clinical and public health research to guide health
service priorities for preventing suicide in England
NIHR via
AWP
30/04/2017
£562,491
Development of content for an online Cognitive Behavioural Therapy (CBT)
platform
Alzheimer’s
Society
TBA
£108,869
Treating insomnia in patients with delusions and hallucinations: a pilot
randomized
NIHR
28/02/2015
£250,556
NIHR Diagnostic Evidence Co-operative
NIHR
31/08/2017
£989,754
Sponsor/Clinical Research
Organisation
Study
Antidepressant controlled trial for negative symptoms in schizophrenia (ACTIONS)
Glutathione Phase 2 study
NIHR
Glutathione 2
Stem cells for Biological Assays of Novel drugs and predictive toxicology (STEMBANCC)
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University of Oxford
[PUBLIC ]
Commercial funded studies
Sponsor/Clinical Research
Organisation
Study
FLASHYLYTE RO4917838 in stable patients with persistent, predominant negative
symptoms of schizophrenia treated with antipsychotics - Protocol No. NN25310
Roche
A randomised, double-blind, placebo- controlled, phase 3 study to evaluate the efficacy
and safety of once a day, TAK-375 (Ramelteon) tablet for sublingual administration (TAK375SL tablet) 0.1mg and 0.4mg as an adjunctive therapy in the treatment of acute
depressive episodes associated with bipolar 1 disorder in adult subjects (TAK_301)
Takeda
A randomised, placebo-controlled, parallel-group, double-blind, efficacy and safety trial of
MK-8931 in subjects with mild to moderate alzheimer's disease EPOCH
Merck, Sharpe & Domme
Long-term safety and efficacy of ABT-126 in subjects with schizophrenia: a double blind
extension study for subjects completing study M10-855
A randomised, double-blind, placebo-controlled, single-dose, study of the efects of SEP
363856 and Amisulprode on bold-FMRI signal in healthy male and female volunteers with
high or low schizotype characteristics
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AbbVie
P1vital \ Sunovion