PUBLIC
Report to the Meeting of the
Oxford Health NHS Foundation Trust
Board of Directors
24 June 2015
Research and Development Report
Page 1 of 41
PUBLIC
1 Clinical Quality and Care
Participation in research produces widespread benefits for patients and, more generally,
improvements in quality of care. A consumer poll of 3,000 people in England,
commissioned by the NIHR and published in September 2014, reported that 95% of those
responding stated that it is very important that the NHS carries out clinical research; with
85% of people agreeing that they would be very or somewhat willing to take part in
research if they were diagnosed with a medical condition or disease. Oxford health NHS
Foundation Trust has strong links to the University of Oxford, a thriving R&D department
and a Clinical Research Facility which enables high quality research to take place for the
benefit of patients and carers.
2 Networks and Collaborations
2.1 Oxford Academic Health Science Network (OAHSN)
Oxford Health is hosting three OAHSN themes;

Early intervention led by Prof Belinda Lennox and Sarah Amani.

Anxiety and Depression led by Prof David Clark and Ineke Wolsey.

Dementia led by Dr Rupert McShane.
2.1.1 Early Intervention Theme
The Early Intervention in Mental Health Network brings together local experts on
adolescent and young adult’s mental health and those with experience in system-wide
transformation with the purpose of improving outcomes for young people with mental
health problems via Early Intervention in Psychosis (EIP) services.
The Early Intervention network is jointly led by Dr Belinda Lennox (Consultant Psychiatrist,
Oxford Health NHS Foundation Trust) and Dr Mark Allsopp (Consultant Psychiatrist,
Berkshire Healthcare NHS Foundation Trust) and is managed by Sarah Amani
The outcome objective is to improve health and social outcomes for patients with first
episode psychosis, including duration of untreated symptoms, symptom reduction, and
engagement with education and employment. The measurable metrics specifically look at
NEETs (Not in Education or Employment) - the % NEETs of people in EIP services vs the
% of NEETs not in EIP services.
2.1.1.1 Communications have included the following:





Network Event 31st March 2015
Monthly Network Business meeting
Bi-monthly EIP Practice Group
Bi-monthly Extending EI Group
Bi-monthly Transition Work Group
Page 2 of 41
PUBLIC




Ad-hoc Research Work Group
Ad-hoc, CCG, GP and Operational Managers
Regular Twitter feed (14K followers)
Quarterly EI Newsletter
2.1.1.2 Project performance Indicators
a) PID 1 Enhancing care continuity and extending the model of early Intervention
Metric
Timing
Trust level action plans for
improving care continuity
agreed
January
2015
Improved care continuity in
young people with psychosis
in a single NHS Trust
Improved care continuity in
young people with a mental
illness other than psychosis,
in a single NHS Trust
Status
Complete - Trust level action plans for improving
care continuity agreed (15th Jan 2015). Action
Plans submitted to EIP Best Practice Group 13th
March
July 2015
(April 2015)
April 2016
Delayed – Single Trust selected is Oxford. Data
will be sought from EPR implementation due April
2015; data will be available in July 2015
In progress – Plans to focus on eating disorders as
next mental illness in line with national priority.
Preliminary discussion in progress within Network
team on how best to support and implement
improvements.
b) PID 2 Common Assessment
Metric
90% staff working in EIS
trained in standardized
clinical assessment of
psychosis.
Completion of baseline
data on new
assessments
New patients entering
EIS fulfilling criteria for
EIS on standardized
clinical assessment
Agree baseline data
metrics and IT data
collection methods
Timing
December
2014
July 2015
(April 2015)
July 2015
Status
Completed March 2015. Further training planned in
June 2015 to capture remaining 10%
Delayed due to agreement on National Common
Assessment and implementation of EPR across
participating Trusts. Confirmation of National Common
Assessment will be available in the next few weeks.
Trusts in the Oxford AHSN region will use a common
assessment that exceeds the national requirement.
Oxford Health planned implementation June 2015,
Berkshire September 2015 (Source: EIP Best Practice
Group May 2015)
Delayed due to issues identified above
(April 2015)
July 2015
(December
2014)
Delayed - Local metrics agreed but KPI delayed due to
pending decision on National Common Assessment and
implementation of EPR in April 2015
c) PID 3 – Reduce Variation
Page 3 of 41
PUBLIC
Metric
Timing
Status
Identify baseline for care quality measure
across AHSN
January 2015
Complete
Action plan for improving care quality in
each Mental Health Trust
August 2015
Due - This is being linked in with
the South England EIP-P work
action plans. To be discussed at
EIP Best Practice Meeting on 10th
July 2015
Fidelity to services to the EIPS model of
care (NIMHE) and narrative report from
services on pressures on maintaining
NICE compliance
December
2014
Re-measure care quality
(April 2015)
Complete
October 2015
Reduction in variation of care quality for
EIPS across AHSN
Percentage
of
young
people
in
employment or education after 3 years EIP
compared to peers
April 2016
April 2016
d) PID 4 Research Recruitment
Metric
Timing
Research champions identified in EIP teams
Number of research studies and current activity identified
Database of research ready participants in EIP
Accruals to Portfolio research studies
Number of research studies active in EIP (increase)
August 2014
October 2014
July 2015
April 2016
April 2015
Status
Complete
Complete
Due
Additional Outcomes – Clinical Lead and Network Team to support NHS England (South)
Early Intervention in Psychosis Preparedness programme.
2.1.1.3 Budget
Total budget allocated £210k. The theme will be extended to March 2016 without the need
for additional funding. Funding released by support for Clinical Lead and Network Manager
by South East EIP may be used to support EI Enhancing Care Continuity project Chair and
PPIEE post.
2.1.1.4 Future Plans




Development of a detailed plan to extend the EIP model to Eating Disorders
Development of the EIP Champions deliverables and KPIs
Publication of HSJ article – ‘Demonstrating the effectiveness of Early Intervention
Psychosis services using health system analytics’
Development of local EIP Preparedness plan
Page 4 of 41
PUBLIC
2.1.1.5 Key risks to successful delivery

Impact of EIP programme on Oxford AHSN EI Network delivery – Mitigating action:
scope of EIP project and team responsible for delivery has been clarified. OAHSN
to provide interim Network Management support.

Agreement of National Common Assessment criteria and assessment, and
Implementation of EPR across the Trusts to allow data collection, are significant
factors in the timely delivery of PID 2 (Common Assessment) and PID 3 (Reduce
Variation). EPR implementation deadline is October 2015. PIDs timeframes may
need to be revised.
2.1.2 Anxiety and Depression Theme
This theme covers three areas:
2.1.2.1 Understanding outcome variability and improving recovery rates for Talking
Therapies (IAPT)
The initial aim of the PID was to improve the overall recovery rate achieved in the IAPT
services by 5%. Two distinct activities were planned. First a series of enhancing recovery
workshops would allow the clinical leads of the services to share learning and hear about
relevant research findings. Second the download and analysis of one years’ data from the
services in order to identify any additional lessons and act upon them.
The aim has already been exceeded and there are three enhancing recovery workshops
ongoing with agreed follow up plans after each workshop. The overall recovery rate has
increased from 46 to 54%. These enhancing workshops will continue with the launch of a
series of skills training events for therapists in the IAPT services. The first is focused on
improving diagnostic accuracy; some analysis of the national data showed an associated
higher recovery rate overall. Other workshops that are planned cover enhancing therapist
skills to treat depression, post-traumatic stress disorder, social anxiety disorder, specific
phobias and distress in couples. Two of the workshops will be delivered by Professor
Clark and his team and will cover the treatments they have pioneered. The other three
workshops are being conducted by world leading authorities in the relevant condition from
Europe and North America.
Relevant permissions are no in place for downloading 15 months of data from each of the
IAPT services and a statistician has been appointed to conduct detailed analysis to identify
new lessons.
2.1.2.2 Supporting local service
throughout the region
innovation
and
disseminating
successes
The deliverable for this project was to ensure that each of the IAPT services adopts a new
service innovation. This is progressing on track with all services now adopting new
initiatives




Milton Keynes: CBT-1
Buckinghamshire: Diabetes
Oxfordshire: COPD
Luton: Psychological Perspectives in Primary Care (PPiPCare)
Page 5 of 41
PUBLIC

Berkshire: Enhanced diabetes care and MUS treatments
Implementation plans are currently being completed and necessary training is being set
up.
2.1.2.3 Improving data completeness in CYP IAPT
Work is ongoing with the CAHMS services and the CYP IAPT (Children and Young
People’s Improving Access to Psychological Therapies) collaborative to increase the
average data completeness of paired outcome data (i.e. pre and post treatment) across
the OAHSN patch by 10%.
The national database for CYP IAPT (Children and Young People’s Improving Access to
Psychological Therapies) cannot be used for baseline data due to incomplete and
meaningless data that is not fit for the desired purpose. Therefore it was decided to work
with data extracted directly from the CAMHS services. This has been a time consuming
and complicated piece of work as all localities have different systems internally and have
fragmented systems that do not record all of the required data in one place. For example,
admissions and discharges may be in one place, but any recorded outcome measures in
another. The data is nearly complete for Q4 which more realistically reflects actual activity
in the services and will be used as a baseline. Good progress has been made due to the
support from the Network in addressing these data collection issues. Meetings with all
services are being planned to explore baselines and agree on an improvement plan for
recording and submitting paired (pre and post treatment) outcome data.
2.1.3 Dementia Theme
2.1.3.1 Successes
The Memory Services Accreditation Programme.
The Dementia Network has
stimulated, and provided funding to support, Oxford Health’s attempt to gain accreditation
of 5 memory clinics. This has been ably led by Maureen Cundell, the deadline for
uploading data is June 2nd and it looks as if most, if not all, teams will meet this. This
process has already helped to identify areas where we could do better. The process will
complete in September 2015.
A webinar programme is established. A joint bid to HETV and the Clinical Research
Network has resulted in the purchase of kit (suitcases containing an ipad, projector,
microphone and speakers) which make it possible for small teams to attend webinars
together. This is at the point of starting to be used. The forthcoming programme includes
clinicopathological conferences, and an emphasis on reducing variation in the diagnosis of
Mild Cognitive Impairment in secondary care.
Charities. The Young Dementia charity in Berkshire has secured agreement from
commissioners to support it. This is a major achievement for Dr Jacqui Hussey and her
team in Berkshire. Oxfordshire also has a similar charity: Young Dementia UK (YDUK).
The Berkshire charity has found that giving the charity staff honorary NHS contracts and
access to relevant patient records has been a significant element in improving quality of
care. It has been proposed that Oxford Health does the same for YDUK. We are currently
trying to identify someone who would be prepared to take on nominal line management for
these workers. Bucks has no service for this group. We propose to try to involve Bucks
Page 6 of 41
PUBLIC
commissioners in the September 2015 event with a view to highlighting this variation in
provision and presenting the economic case as it is established in Berkshire.
2.1.3.2 Other Developments
The data capture project which is developing the use of texting as a platform for getting
direct data from carers (e.g. on resource utilisation) has been sluggish in a pilot phase,
partly due to consent to contact issues. It has been agreed that this should be given until
March to ‘sink or swim’.
The eSilverBook initiative has been dropped. As it was a piece of IT development, the
AHSN did not think this was an appropriate use of Clinical Network resources.
Following a 25% cut in overall network funding, the deltaG project to improve taste of a
novel food for dementia was not thought to have the necessary priority.
A detailed proposal for an Open University Tier 3/Tier 4 online course for experienced staff
was not funded by HETV.
The adoption of ‘clinical safety’ related messages on screen savers, as is used in
Berkshire Healthcare, foundered on the conflict between this and a Trust policy on
conserving the energy required for screensavers.
2.2
OXFORD NIHR Collaboration in Leadership in Applied Health Research and
Care (CLAHRC)
The CLAHRC is led by Professor Richard Hobbs (CLAHRC Director) and supported by
Alex Gardiner (CLAHRC Manager) within the Department of Primary Care at the University
of Oxford.
The following are relevant extracts taken from the 2014/15 CLAHRC annual return
submitted in May 2015:
2.2.1 Progress against CLAHRC Objectives
We have made good progress against our short term aims, recruiting and part funding 3
Academic Clinical Fellowships (ACF’s), 4 DPhil’s, and a junior clinical academic as
‘researcher in residence’ in the Emergency Multidisciplinary Unit (OHFT). In addition to
this, 5 further matched funded ACF’s are working within our host trust supporting CLAHRC
projects and benefitting from the academic expertise and training support provided by the
CLAHRC. Future plans include the recruitment of a senior academic with matched funds to
lead a cross cutting complex evaluation theme and the development (with key
stakeholders) of a second multi-morbidities cross cutting theme with the emphasis on
informing priority setting for our CCG partners’ procurement.
Our medium term aims of generating high quality evidence for clinical and cost
effectiveness has already shown impact through the NIHR CLAHRC Oxford Early
Intervention and Service Redesign Theme/AHSN collaboration Early Intervention in
Psychosis project lead by the CLAHRC Deputy Director, Professor Belinda Lennox. We
have also increased the number of projects across the CLAHRC from the original number
of 19 to a current total of 32. We will be addressing this aim in our 2 year review in addition
Page 7 of 41
PUBLIC
to expanding our portfolio of current work to address key public health priorities, with a
focus on multi-morbidities.
The NIHR CLAHRC Oxford research programme is driven by our long term aims to build
research capacity within the NHS, to support evidence based commissioning and service
development and to build an infrastructure to enable the responsiveness of services to
patients’ reports of experiences and outcomes at the local level. Progress towards these
aims has already been made: discussions have taken place with Oxfordshire CCG to
identify their main priorities for the future which will inform the review taking place at the
end of year 2 of the CLAHRC and shape the direction of the final 3 years of the
programme; the Said training programme detailed in the training section below was
developed in conjunction with Oxford Health NHS Foundation Trust to embed a culture of
research within the clinical teams and to provide the expertise and support to enable them
to identify and overcome barriers to change and to successfully implement innovation with
the aim of creating a ‘knowledge ripple effect’ supporting others within their organisations
to do the same.
2.2.2
Changes to the NIHR CLAHRC Strategy
There have been no substantive changes to the strategy, however we are driving towards
strengthening both our local and UK wide Infrastructure links and level of industry
involvement. We aim to be to be flexible, responsive and useful to the NHS and to achieve
these goals we need to be quick at responding when new projects appear, whilst still
maintaining capacity development for the future. The areas for development going forward
are:




2.2.3
Increasing the number of experienced Principal Investigators
Developing relationships with stakeholders, both new and historical
Working more closely with other CLAHRC’s
Developing relationships and opportunities with Industry
Developments in implementing the NIHR CLAHRC strategy
The Research Excellence Framework results for 2014 highlighted that the NIHR CLAHRC
Oxford is a strong centre for academic excellence with 3 of the areas hosting CLAHRC
themes and key CLAHRC projects being ranked as world leading (4*) in this exercise –
Department of Psychiatry, Department of Public Health and the Department of Primary
Care Health Sciences. During the first year we have worked towards the vision of ‘One
NIHR’ strengthening our infrastructure collaborations to provide a vehicle for excellence.
This is evidenced by some of the new projects being supported by the NIHR CLAHRC, for
example POPS2 which was only possible due to our strong working collaborations with
other CLAHRC’s, the School for Primary Care Research and the Thames Valley Local
Clinical Research Network. In addition our collaborative projects with the Oxford AHSN
has seen the NIHR CLAHRC work closely with NHS England, successfully building new
clinical networks e.g. Out of Hospital Care and Early Psychosis leading the access and
waiting time gold standard.
2.2.4
Training initiatives and Developments
The NIHR CLAHRC themes are currently in the process of identifying a new training lead.
This is an extremely important role within the CLAHRC and so important that the right
Page 8 of 41
PUBLIC
person is appointed to the role. Until the appointment to this role, Alex Gardiner CLAHRC
Senior Manager will be the key contact for training.
In March 2015 the NIHR CLAHRC Oxford piloted a unique leadership training course
developed in conjunction with the Said Business School and Oxford Health NHS
Foundation Trust, and hosted at the Said. The aims of this course were to plug a
knowledge gap identified between junior and senior levels of management across the
whole trust structure (clinical and non-clinical), to provide the skills for trust managers to
drive the implementation of new research and to provide a network of support with
researchers to help give context and expert support with understanding novel research
and its implications for the NHS.
2.2.5 NIHR CLAHRC Oxford’s top three achievements were:



Number of high impact papers – 4 papers were published in The Lancet, all of
which will have impact on the provision and delivery of services in palliative care
and physiotherapy treatments;
Early Intervention in Psychosis Service – this exemplar project is an early win
informing national policy, and leading to the formation of the national expert
reference group;
BBC Horizon ‘What’s the Right Diet for You?’ – this ground-breaking social
experiment launched the OxFab trial and will provide a platform for new projects in
the third year of the CLAHRC.
2.2.6 Matched Funding Highlights



2.3
Early Intervention in Psychosis – match funded by the Oxford AHSN has already
had significant impact on the provision of care young people with psychosis in
addition to leading to the development of new national guidelines;
Emergency Multidisciplinary Unit – matched funded by Oxford Health NHS FT,
Oxfordshire CCG, the Oxford AHSN and the NIHR BRC Oxford. In addition to the
main EMU evaluation project and development of a commissioning model in
underway to provide decision support for commissioners and acute and community
providers. The EMU innovative model of care has received interest in roll out both in
the UK and overseas and won the Guardian Innovation Award for Service Delivery;
Depression Care for People with Cancer – matched funded by Oxford University
Hospitals NHS Trust and the Oxford AHSN, this unique and innovative screening
and treatment programme piloted by the Oxford Cancer Centre has provided high
quality, evidenced-based integrated care for patients with mental and physical
comorbidity.
NIHR Diagnostic Evidence Co-operative (DEC)
The DEC is led by Dr. Ann Van den Bruel (Senior Clinical Research Fellow) within the
Department of Primary Care at the University of Oxford.
The following are key extracts from the 2014/15 annual return submitted in May 2015:
Page 9 of 41
PUBLIC
2.3.1 Short term objectives:





Identify new IVDs (in-vitro diagnostics) relevant to primary care: Our horizon
scanning programme has produced eight reports on diagnostic tests in primary
care. In addition, we have interacted with eight diagnostic companies who are
developing new IVDs to advise them on primary care applicability.
Produce rapid technology assessments: the horizon scanning programme has
published eight reports so far. Topics range from point-of-care malaria tests to
calprotectin and cardiac markers. Ongoing horizon scanning reports include pointof-care streptococcal A tests for sore throat, point-of-care tuberculosis tests and
point-of-care respiratory panel tests.
Hold annual stakeholder meeting: the next UK Diagnostics Forum was held from
19-20th May 2015. As for the previous editions, the Forum was again jointly
organised with NICE, the British In-Vitro Diagnostics Association and Innovate UK
(formerly Technology Strategy Board). This year’s theme focused on how to create
value by introducing new tests in healthcare. The Forum was attended by 120
delegates and was fully booked 1 month in advance.
Hold annual 3-day educational course: the first annual 3-day course was held from
22-24 September 2014 in Queen’s College, Oxford. The course was aimed at all
professionals working on diagnostic tests including people working in industry,
academia, funding bodies, test regulation. The course was attended by 19
participants, of whom 10 were from the diagnostics industry, three from another
DEC, three from HTA agencies (UK and Europe) and three clinicians. A more
detailed evaluation report of this course is added as an appendix.
Produce case studies: our case study on the Abingdon Emergency Multidisciplinary
Unit (EMU) has well progressed since the previous annual report. This unit, which
was awarded the 2013 Guardian Healthcare Innovation Award, provides care for
elderly patients with multimorbidity and frailty. The unit combines a multidisciplinary
assessment with point-of-care in vitro diagnostics to assess patients’ health status
and their care needs. The impact of the point-of-care tests is being evaluated using
a variety of methods including analyses of hospital admission rates, method
comparison studies on correlation between point-of-care and classic laboratory
results, and qualitative analyses of care processes.
Medium term objectives:



Direct academic and industry research efforts towards unmet needs: we have
published the first results of our international survey in 2014. We have seen large
interest from industry for these results, and the paper’s full text, which was
published open access to facilitate dissemination, has been downloaded 3367 times
since its publication. We have now analysed additional data for the UK, including
which point-of-care tests general practitioners would like to monitor chronic
conditions and to refer patients to secondary care. The results of these analyses
have been submitted for publication.
Consolidate platform approach primary care assessment
Develop consultation service for industry: we have set up a consultation service for
industry that includes a variety of services, including advice on primary care
application of new IVDs, in collaboration with ISIS consulting.
Page 10 of 41
PUBLIC
Long term objectives
We have consolidated our expertise in diagnostic test evaluation. A major strength of our
research team is the multidisciplinary approach, including clinicians working in various
settings of the NHS, methodologists and statisticians, health economists, qualitative
researchers and clinical biochemists. We have established important links both nationally
and internationally, including collaborations with the other DECs and the Birmingham
Biostatistics group, with the HTA Diagnostic Tests and Screening panel and methods
group, with the international STARD group on reporting diagnostic test evaluations, the
Amsterdam Clinical Epidemiology Department, the Utrecht Department of Epidemiology. In
addition, we have intensified our industry outreach programme by appointing a new
researcher (Dr Philip Turner) who now oversees all industry liaison activities.
Significant developments in implementing the strategy
We have established a strong regional collaborative approach which allows diagnostic
companies to receive advice from very early stage development up to pre-market. For this
purpose, we have established links with ISIS Consulting to signpost new diagnostic
inventions to our DEC for early stage advice, and with the Oxford AHSN and CLAHRC for
late stage implementation advice.
Major grant awards received as a consequence of NIHR DEC funding





2.4
Translational Research Fellows in acute ambulatory care, NIHR Oxford BRC RCF
£57k
Nursing Translational Research Fellow, NIHR Oxford BRC RCF £43k
Postdoctoral health economist, Oxford University Hospitals RCF £48k
Innovate UK Small Business Research Initiative: Home-based monitoring for the
early detection of severe neutropenia in patients receiving chemotherapy to enable
intervention and avoidance of adverse events. Lead Participant Philips Electronics
UK Limited, DEC collaborators Prof Chris Price and Dr Jane Wolstenholme. £2.0m
Prime Minister’s Challenge Fund: Oxford Clinical Commissioning Group. Strategies
for reducing hospital admissions including better diagnostic assessment. £4.9m
NIHR Oxford cognative health Clinical Research Facility (CRF)
The NIHR CRF is led by Professor John Geddes.
The following are key extracts from the 2014/15 annual return submitted in May 2015:
2.4.1 Progress Against short, medium and long term objectives
Short-term objectives
‘To underpin the capacity of the Oxford experimental neuroscience clinical research
facility and to manage support staff efficiently across the facility’.
The Lead R&D Nurse/CRF Matron came into post 18 months ago. This senior nursing
appointment has allowed development of the research nursing team to provide a broader
range of skills to researchers. Newly appointed research nurses have come from different
specialisms e.g. thrombosis research and ‘early intervention in psychosis’ mental health.
Junior nursing staff is supported through their preceptorship, NMC exams and registration.
Page 11 of 41
PUBLIC
A number of nursing staff are either in the process of gaining postgraduate qualifications
(e.g. including MSc, MRes, Professional Doctorate) or are planning to do so. This skill mix
allows the CRF to deliver research more efficiently. The Matron is developing other roles in
the wider research organisations and local NHS Trusts. For example, she is an active
member of the CRN workforce development on behalf of Oxford Health NHS FT and has
undertaken training to deliver the NIHR GCP training program locally.
The main provision of research nurses is for the eight-bedded site of the NIHR Oxford
CRF located at the Warneford hospital – a psychiatric hospital. However the CRF also
includes The Charles Wolfson Centre led by Professor Peter Brown. The successful
appointment of a suitably qualified research nurse to support the Charles Wolfson centre
was proving a challenge, this resulted in the rethinking of collaborative support across the
sites. The solution was the appointment of a full time band 6 research nurse, who works
across the sites. This allows cross cover, expansion of skills and improved efficiency in
terms of staff management.
The CRF provides training opportunities to staff from CRN Funded Division 4, in particular
staff employed within DENDRON under the previous CLRN structure. DENDRON
research nurses spend time on the CRF to gain experience in a variety of trials from
experimental medicine to later phase commercial studies.
The Lead R&D Nurse/CRF Matron is closely involved in the line management of seven
Research Assistants. Two of these are for the Early Intervention Service funded by the
CRN to support one of the themes of the Oxford AHSN. The other five are funded by
Oxford Health NHS Foundation Trust and are embedded within clinical teams. This is an
illustration of how the Lead R&D Nurse/CRF Matron of the CRF works across
organisations to improve active collaboration.
‘To support major new investments by Oxford University in translational neuroscience to
facilitate the delivery of advances in diagnostic and interventional procedure to clinic in the
area of neurological and psychiatric disorders’
One of the major initiatives planned for 2015 is the expansion and conversion of OHBA
(Oxford centre for Human Brain Activity http://www.ohba.ox.ac.uk/) on the Warneford site
into a Translational Cognitive Neuroscience Imaging Centre. This £3.9 million venture, has
attracted £2 million of central University funding matched by £1.9 million from the
University Department of Psychiatry will see a state-of-the-art research-purposed 3-Tesla
magnetic resonance imaging (MRI) scanner added to the magneto-encephalography
(MEG) system and an upgrading of the OHBA facility. The new multi-modal facility will linkup world-class discovery science and clinical care, by making cutting-edge multi-modal
brain-imaging technology available for experimental medicine studies, clinical trials and
innovative clinical care. The new Centre will provide much needed increased MRI capacity
for large-scale neuroscience projects to deliver high impact science to benefit patients by
improving patient access to high-throughput multimodal brain imaging. An important aim is
to achieve a step-change in developing multimodal imaging-based biomarkers relevant to
a wide spectrum of disorders of cognitive health and increasingly required for early phase
commercial studies.
The 2014-15 financial year has been spent laying the groundwork for the new
development, which is now mid-programme. The planning application was submitted in
March 2015, and the construction work is scheduled for July-December 2015, ready for
Page 12 of 41
PUBLIC
opening in January 2016. This development will increase the capability for neuroscience
research in Oxford and will be much more convenient for participants who currently have
to travel across Oxford from the CRF for MRI.
‘To support complex later phase trials of pharmacological and psychological interventions
to establish efficacy and the mediators and moderators of change’.
The CRF continues to support later phase trials, that are not feasible in routine clinical
care, this has included repeat business from existing pharmaceutical companies and
Clinical Research Organisations in addition to the establishing new links with other
companies.
‘To integrate the clinical and research governance of the CRF with the Joint Research
Office of the Oxford Biomedical Research Centre’
The Head of R&D Finance continues to work with the CRF and provides invaluable links
between the NIHR, CRF, the NHS Trusts (Oxford University Hospitals - OUH- NHS Trust
and Oxford Health NHS Foundation Trust - OHFT) and University of Oxford. He continues
to play a key role in supporting the financial elements of grant application across the
organisations, in addition to providing support for determining occupancy across the four
sites of the CRF.
Oxford Health NHS FT has sourced support from the JRO for monitoring of research
studies ongoing within the CRF in addition to setting up an agreement for the JRO to
provide legal advice on non-standard contracts, subcontracts between external
organisations and reviewing NIHR Standard template contract where pharmaceutical
companies are requesting additional clauses to the agreements
A research team lead by Prof Heidi Johansen-Berg is part of the Functional Neurosciences
& Imaging subtheme of the BRC. Several of our patient research projects conducted in the
CRF are funded by contributions from the BRC. In addition the group have ongoing
collaboration with the Cognitive Health Working Group (head: Kia Nobre), another theme
of the BRC.
Discussions are evolving on how this collaboration can be extended are ongoing.
‘To create, for the first time, an Oxford research partnership integrating neuroscience
research across the Oxford University Hospitals NHS Trust, Oxford Health NHS
Foundation Trust, the University of Oxford (Experimental Psychology, Neurology and
Psychiatry), Oxford Brookes and the local Clinical Commissioning Groups’
Excellence in both basic and translational research across the Oxford Neuroscience
partnership is reflected in the outcome of the Research Excellence Framework (REF) 2014
exercise which highlighted the University of Oxford’s world leading position in Psychology,
Psychiatry and Neuroscience. In this area the University ranked first place in the UK in the
overall quality of the submission, and had the highest proportion of world leading research.
A score of 100% was given for the quality of the research and training environment and
95% of the submission was rated as world leading or internationally excellent. This is an
outstanding performance and reflects excellence in both basic and translational research.
There is increasing collaboration across OUH NHS Trust, Oxford Health NHS FT, Oxford
University and Oxford Brookes University under the aegis of the Oxford Academic Health
Science Centre. .
Page 13 of 41
PUBLIC
Medium term objectives
‘To produce a step change in Oxford translational neuroscience, harnessing cutting edge
advances in neuroscience from world class Departments, supported by state-of-the-art
technical platforms and research facilities to deliver benefits for patients’
The CRF is a central component of the development of translational neuroscience
collaborations and resources across Oxford. Over the last 12 months, developments have
accelerated and mental and cognitive health are now firmly at the centre of Oxford’s
overall strategy. We have continued to build research capacity in dementia and cognitive
health via the Oxford AHSC Cognitive Health theme (Lead: Geddes) and OxDARE
consortium. Professor John Gallacher, principal investigator of Dementia Platform UK has
recently moved to Oxford. Professors Simon Lovestone and Chas Bountra of the
Structural Genomics Consortium (SGC) (http://www.thesgc.org/scientists/groups/oxford/)
have successfully obtained £10 million funding from Alzheimer’s Research UK for a Drug
Discovery Institute which will be based in the Target Discovery Institute
http://www.tdi.ox.ac.uk/home and provides an innovative, precompetitive and collaborative
approach to drug discovery. Professor Noel Buckley has been recruited to build capacity in
target discovery. The NIHR supported D-CRIS informatics programme will shortly be
implemented in Oxford and the leadership (Mike Denis and Simon Lovestone) is now
based in Oxford. The major EU IMI EPAD adaptive trial award has now been made and is
co-led from Oxford. These developments are truly transformational and we believe that
Oxford is well on the way to being an internationally leading centre of dementia research.
Although the developments in translational dementia research are perhaps most striking,
there has also been continued development of our excellence in other areas. These
include:

Psychological treatment research, with the recruitment of Professor Willem Kuyken
(and associated Wellcome Trust Strategic Award) building on the established
critical mass - including, for example, Professor David Clark’s pioneering and high
impact development of Increasing Access to Psychological Treatments (IAPT), Prof
Chris Fairburn’s innovative work on improving training in psychotherapy among
other world class researchers increasingly using the CRF.

Mood disorders - building on the established and continuing work in depressive
disorders (Profs Cowen, Goodwin, Harmer) and bipolar disorder (Geddes,
Goodwin) with the new CONBRIO Wellcome Strategic Award (Harrison, Geddes,
Nobre, Harmer et al) which brings integrates deep phenotyping with large scale
epidemiological studies to transform our understanding ion mood instability and to
develop new experimental medicine models.

Further developments underway in developmental disorders (Stein, Newton, Scerif)
and early psychosis (Lennox, Broome, Harrison)
Underpinning all this major expansion of academic research programmes is a commitment
to provide the required underpinning infrastructure to complement the CRF. The University
of Oxford and Oxford Health NHS Foundation Trust are working together on a joint
masterplan for development of the Warneford site, which occupies a strategic and central
position on the Headington Academic Health Campus, as a centre for translational
neuroscience.
Page 14 of 41
PUBLIC
Long term objectives
‘To successfully apply for a new Biomedical Research Unit dedicated to Cognitive Health,
strongly coupled to the Oxford Biomedical Research Centre and focused on delivering
Oxford University benefits for patients Research areas to be supported by the CRF’
The CRF is at the core of our plans to develop translational cognitive neuroscience in
Oxford. We plan to expand translational cognitive neuroscience research which uses the
CRF. Regular planning/steering meetings have been established between Oxford Health
NHS FT and the University of Oxford to develop an application for a Biomedical Research
Unit/Centre in the next funding round to focus on mental and cognitive health. Scientific
themes are being selected and developed, and to infrastructure developed across both
organisations to integrate research more fully and to increase the active involvement of
patients in research.
Progress with leadership, governance and management arrangements
Professor John Geddes continues to provide strong leadership of the CRF and links to the
Oxford BRC and OUH Trust via the BRC Steering Committee. Professor Geddes is
supported by the Head of R&D, Emma Stratful, and Leads for the CRF sites, Dr. Mary
Jane Attenburrow, Professors David Clark, Glyn Humphreys and Peter Brown. This group
along with the Head of R&D Finance and Matron for the CRF form the core membership of
the CRF Management Board which meets on a regular basis to discuss key operational
and strategic developments. There is strong emphasis on training and developing staff
and the Matron for the CRF is an active member of the NIHR workforce development
programme. The Head of R&D/Senior CRF Manager has also embarked on an executive
MBA, supported by the Trust and OUH BRC. Following the retirement of the Research
Governance Manager at OHFT in December 2014 the Trust appointed a new senior
manager, Victoria Rush, who joined in June 2014. With this appointment there is focus on
improving efficiency in managing studies and producing required metrics. For example;
ensuring alignment of study and recruitment figures between the Trust and the NIHR
portfolio studies, developing more structured ways in which to capture key and relevant
data surrounding study approvals, including database development and alignment with
systems created within the OUH. The Governance Manager is leading on the transition of
the Trust into the HRA processes for research governance and as such has instigated
meetings to address feasibility of studies being undertaken within the Trust in line with the
proposed HRA agenda. The Research Governance Group has been re-established to
oversee all research governance processes, issues and updates within the Trust, including
setting up of risk based monitoring of studies and a safety review group for noncommercial studies. More robust processes have been developed regarding the
sponsorship of individual studies to ensure the Trust is able to fulfil its obligations.
Changes to the strategy and significant developments in implementing the strategy
Oxford Health NHS FT executive board continues to receive biannual R&D reports,
including a stronger emphasis on the outcomes and impact on clinical care as a result of
research studies. The Research Implementation Manager, Alexandra Forrest was
appointed in November, 2014. This important role includes coordinating the delivery of the
‘research opportunity’ message to all clinicians and service users, helping researchers
identify recruitment methods and coordinating research delivery by collaborating with key
members of the NIHR CRN, NIHR CRF and researchers from the key University
Page 15 of 41
PUBLIC
Departments and NHS Trusts. In order to achieve the aims of the role Oxford Health
NHSFT supports five RAs embedded within clinical teams in Adult Mental Health who are
managed by the Research Implementation Manager.
In addition the NIHR CRN has funded an additional two research assistants to support the
early intervention service within the organisation who are also managed by the Research
Implementation Manager. The Research Assistants have been key in the successful
undertaking and delivering of an NIHR portfolio study looking at hospital admissions
(COFI).
The R&D Strategy Forum continues to meet twice a year, with a focus on developing the
NIHR BRU application and improving relationships between OUH, University of Oxford,
Brooke University and OHFT for the increasing nurse delivered research and nursing lead
research within Oxford.
A R&D Senior Management Team (SMT), consisting of the Director of R&D and CRF
(John Geddes), Head of R&D and Senior Manager of the CRF (Emma Stratful), Deputy
Director of R&D and Clinical Director for the CRN (Belinda Lennox), Clinical Lead for CRF
(Mary Jane Attenburrow), Research Governance Manager (Vicky Rush), Head of R&D
Finance (Bill Wells), Lead R&D Nurse and CRF Matron (Cindy Whitbread) and Clinical
Trials Pharmacist (Orla McDonald) for OHFT has been established to provide assurances
on research governance and to resolve any queries related to the set up and conduct of
studies within the organisation, in addition to assessing the risk associated with complex
studies and provide decisions on whether to host the study. The SMT also oversees the
R&D finances and decides on strategic expenditure where appropriate as some studies in
the CRF may offer training opportunities or special scientific interest that.
Key developments over the last year
The new Research Governance Manager implemented a number of meetings and
systems to track studies through the research process from expressions of interest to
study set up and NHS permission. These meeting include representation from the
Research Delivery Managers of the CRN. Groups review individual studies and where
decisions cannot be reached they are referred to the SMT.
Significant successes and difficulties or barriers to progress experienced;
Studies increasingly require a range of techniques and skills in order to fulfil protocol
requirements for ‘deep phenotyping’. The EU Innovative Medicine Initiative StemBANCC
programme uses the CRF to take skin biopies to grow Induced pluripotent stem cells
derived from fibroblasts. CRF medics and research nurses have worked with Oxford
University Hospitals NHS Trust, Oxford University Department of Psychiatry and Oxford
University Department of Physiology, Anatomy and Genetics to acquire the skills and
knowledge to be able to deliver this research. This study would not have been possible
without the CRF and recruitment is going well.
Enhancements to the delivery of research
Patient experience on the CRF Warneford site has been captured by asking if patients will
consider completing a questionnaire on exit. The questionnaire has been developed using
the UK CRF Network guidance and INVOLVE (www.invo.org.uk/) and has evolved with the
CRF now using version 2. The feedback has been subject to audit with a very favourable
Page 16 of 41
PUBLIC
patient satisfaction. Areas where patient comments have been action is the erecting of a
notice board in the waiting area in addition to a drinks making facility where participants
are able to help themselves to hot drinks rather than feeling they need to disturb busy staff
Intellectual assets
As the CRF has been established relatively recently therefore outputs are yet to be firmly
established. Although Professors Lovestone, Geddes, Hinds and Gallacher) are working
with Apple to develop widely applicable apps (using ResearchKit) to provide sensitive
measures of cognitive function and mood for use in early phase and adaptive clinical trials
in mood disorder and dementia
Major grant awards received as a consequence of NIHR funding.
The Cognitive Neuropsychology Centre within the Charles Wolfson Clinical Research
Facility at the John Radcliffe hospital and part of the NIHR oxford cognitive health CRF
continues to receive substantial numbers of outpatients who come through from the
cognitive screening programme we are running. There has been a slight fall in the number
of outpatient visits due to the Stroke Association funded TMS-neglect project coming to a
follow-up only stage and to our setting-up a nationwide RCT comparing outcomes after
stroke for patients given different types of cognitive screening (the OCS-care programme).
However we have a new Wellcome Trust funded screening project which has just got
underway which will ensure that out outpatient visits are maintained into the future. The
first papers on the Oxford Cognitive Screen are just being published and will continue over
the next year to consolidate the wide-spreading impact of our NIHR-supported work.
2.4.2 Research Projects and Outputs

P1Vital: Sunovion SEP 361-104: A randomized, double-blind, placebo-controlled,
single-dose, study of the effects SEP-363856 and amisulpride on BOLD-fMRI signal
in healthy male and female volunteers with high or low schizotype characteristics.
Recruitment commenced at the end of March 2014 with 34 out of 54 recruited
during the year. There were problems recruiting to the High Schizotype arm of the
study as the participants were often on medication, which excluded them, and they
are a population that is hard to engage but efforts are ongoing

AbbVie: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, ParallelGroup, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of
Cognitive Deficits in Schizophrenia (CDS) in Non-smokers.
This study has
currently managed to over recruit to the target of three participants by one

Long-term safety and efficacy of ABT-126 in subjects with schizophrenia: a double
blind extension study for subjects completing study M10-855. Recruitment to this
extension study was restrictive due to low number entering the initial study and only
one out of the three was recruited.

TAK: 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. Although only one out of the five participants was recruited the CRF were
the only UK team to recruit to this study and the study was closed early
Page 17 of 41
PUBLIC

ATLAS: A pragmatic randomised double-blind trial of Antipsychotic Treatment of
very Late-onset Schizophrenia-like psychosis. This study has recruited one of the
three participants required due to a smaller than anticipated potential inclusion
population.

ACTIONS: Antidepressant controlled trial for negative symptoms in schizophrenia.
Currently 5 participants have been recruited and efforts to increase participation are
ongoing

Merck EPOCH: A randomised placebo controlled parallel group double blind
efficacy and safety trial of MK8931 in subjects with mild to moderate Alzheimer’s
disease. Currently eight out of the 10 participants have been recruited

StemBANCC: Stem cells for Biological Assays of Novel drugs and predictive
toxicology. This is going very well with 22 out of 40 participants recruited.

Mosaic: Comparison of the Maudsley Model of Treatment for Adults with Anorexia
Nervosa has recruited 13 that was handed over from Mental Health Research
Network when the CRNs were reconfigured.

MAPP Mood Action Psychology a case series investigation of brief imagery-focused
cognitive therapy (imCT) for Bipolar Disorder. Study has recruited all 15 of the
target participants

Glutathione 2 study: Comparison of Glutathione levels in patients diagnosed with
Bipolar Affective Disorder and healthy volunteers. This study has completed
recruitment of 90 participants within the year. The CRF was instrumental in
providing facilities and staff for this study to be undertaken to a high level of quality
assurance at short notice. OXTEXT-6: Randomised controlled trial of facilitated
integrated mood management (FIMM) versus manualised integrated mood
management (MIMM) in bipolar disorder. This study has been supported by the
CRF and has recruited 25 participants

OXTEXT-6: Randomised controlled trial of facilitated integrated mood management
(FIMM) versus manualised integrated mood management (MIMM) in bipolar
disorder. This study has been supported by the CRF and managed to recruit 25
participants

SearchLyte/FlashLyte: A Phase III, multi-centre, randomized, 24 week, doubleblind, parallel-group, placebo controlled study to evaluate efficacy and safety of
RO4917838 in stable patients with persistent, predominant negative symptoms of
schizophrenia treated with antipsychotics followed by a 28 week, double-blind
treatment period. Despite co-ordinated extensive pre-screening efforts the study
was only able to recruit two out of the six participants. The study closed in April
2014

TWILYTE RO4917838 Phase III, multi-centre, randomized, 12-week, double-blind,
parallel-group, placebo-controlled study to evaluate the efficacy and safety of
RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia
treated with antipsychotics followed by a 40-week double-blind, parallel-group,
placebo-controlled treatment period. Due to the high intensity of the study visits the
CRF has managed to recruit one out of the six participants
Page 18 of 41
PUBLIC
Professor Humphreys is leading a new area of research for developing a new screen for
impairments in social cognition in brain injured individuals (stroke and dementia).
Currently there is no standardised measurement of social cognition in these populations.
In a new Wellcome Trust Senior Investigator award the group will be developing a clinical
instrument that can be used at the bedside that is not confounded by problems in
language or attention/neglect. The adoption of the OCS as a measurement of choice to
assess cognition after stroke – in over 30 trusts across the UK has been successful
The TMS neglect project is due to be completed in January 2016. The CRF has been vital
to provide the infra-structure support for this project – secretarial support for liaising with
hospital, arranging follow-up visits etc.
The OxCADAT team (PI Professor David Clark) has completed a randomized controlled
trial comparing the world leading face-to-face cognitive therapy for social anxiety disorder
(CT-SAD) with an internet version of the same treatment (iCT-SAD). Analysis is ongoing.
However, it is clear that iCT-SAD is highly effective. Approximately 70% of patients reach
recovery criteria, which is considerably better than the rate (44%) currently reported for
SAD patients seen in the government's Improving Access to Psychological Therapies
(IAPT) programme. OxCADAT is in the process of refining the internet programme based
on patient feedback that was received during the RCT. Once the refinement is complete,
iCT-SAD will be made available in a phased way to local IAPT services, followed by a
national roll-out. All of the data will be stored on our servers so it will be possible to
evaluate the success of a rapid translation from basic research to routine clinical
implementation.
Key scientific or clinical outputs of work carried that has come to light in the last
year
Heidi Johansen-Berg research team have a paper currently under review that describes
positive results of a RCT of tDCS (brain stimulation) combined with a structured
physiotherapy-like motor training intervention which produced significant long-lasting
improvements in chronic stroke patients' upper limb function. It is expected that this work
to have a significant scientific impact. The work was conducted entirely within the CRF
testing facilities in the West Wing of the JR.
2.4.3 Occupancy and Visits
The occupancy and visits data reported in the 2013/14 annual return reflected only three of
the four sites which make up the Oxford Cognitive Health Clinical Research Facility due to
a lack of resources at the Charles Wolfson Centre making it difficult to capture the relevant
data. This year the Centre has been able to provide the data required allowing the 2014/15
return to include all fours sites.
The 2014/2015 occupancy was 60% compared to the 56% reported for 2013/14. This is a
composite figure encompassing the following 4 sites. The total number of visits reported
for 2014/15 is broadly in line with last year.
2.4.4 Patient and public involvement and Engagement
Patient and public involvement
Page 19 of 41
PUBLIC
Embedding PPI into the Research Life Cycle is a priority and the CRF is part of a
developing strategy that will address this across the oxford neuroscience and NIHR
community. There is work to do in this area.
In the meantime links have been established between the various NIHR infrastructures
within Thames Valley in order to share resources and ideas for Patient and Public
Involvement (PPI). The Cognitive Neuropsychology Centre has a PPI panel that advices
on study design and participant information sheets for a specific study conducted on the
CRF Warneford site. The newly appointed research assistants who are embedded in
clinical teams AMHTs and EIS services across Oxford and Buckinghamshire have asked
AMHT service users to review their research promotional materials. OHBA, researchers
from which use the CRF, continues to hold focus groups to provide the public with a
platform to discuss research and any concerns they have and to have input into the
development of new cognitive tests.
There are a range of websites available for patients and the public to find out more
information about research and how to take part in it; Join Dementia Research
(joindemetiaresearch.nihr.ac.uk)
and
Patients
Active
in
Research
(patientsactiveinresearch.org.uk) information are displayed on boards in the waiting room
at the CRF. Further to this, information about research studies can be found at Oxford
Dementia and Ageing Research (OxDARE), and members of the public can sign up to
become a 'Friend of OxDARE'.
CRF staff members have attended various PPI events this year, including the INVOLVE
conference and the CRN Mental Health National Scientific Meeting fringe events.
Attending these events has enabled staff working on the CRF to gain a more in-depth view
how service users can have a role in research and how it can work in different Trusts
across the country
The CRF Warneford site Clinical Lead is taking part in an ongoing James Lind Alliance
(JLA) Priority Setting Partnership (PSP) for Bipolar Disorder. She is a member of the
steering group for the Bipolar PSP along with a researcher at Oxford University Dept of
Psychiatry, colleagues from Leeds NHS Trust, patient representatives, charitable
organisations and representatives from the JLA. The Steering group comprises patients
and their representatives rather than an emphasis on clinicians and researchers. The PSP
is supported by the Oxford James Lind Alliance hub at the OUH BRC who have
established experience in undertaking PSPs. The James Lind Alliance (funded by the
NIHR) PSPs use a recognised methodology to generate patient driven prioritised research
questions
Public engagement
Oxford Health NHS FT have 7 research assistants who are embedded within the adult
mental health teams and the early intervention services across Oxford and
Buckinghamshire. They are able to disseminate research information and opportunities
directly to staff and patients across the county and this has led to and increased the
quantity and diversity of studies available to patients under the care of these teams. They
also ensure that updated information about research opportunities for patients is displayed
across the Trust notice boards.
An audit was conducted on the Warneford site CRF to examine participants’ experience of
research and to use their insight to remove barriers to participation and improve their
Page 20 of 41
PUBLIC
experience of being in research. The feedback from this was very positive. The results
were relayed to the staff enabling positive change to their practice and the environment,
for example, a new coffee vending machine has been purchased for the waiting room.
The Warneford CRF will be hosted an Open Day in May in line with NIHR International
Clinical Trials Day. Presentations included patients who described their experience of
taking part in research the Director of Patient Involvement at the NIHR Oxford Biomedical
Research Centre. There were posters and information leaflets displayed throughout the
day and researchers from various groups demonstrated some of their work
The Experimental Psychology and John Radcliffe West Wing sites have held events to
coincide with national awareness days, such as during Brain Awareness Week, a school
open day was held. The Oxford Biomedical Research Centre also held a public
engagement day on brain diseases and worked together with the Functional Neurosurgery
Team in Oxford to put together interactive stalls for the public at University College of
London Hospitals Science Market in the summer last year.
The CRF at the Warneford site hosted an open day in line with International Clinical Trials
day in May 2015. The day was another successful event with a variety of speakers
including presentations and talks ranging from NIHR networks, what it is like to participate
in research study, specific study overviews, global initiative for Alzheimer’s disease, and
research governance. The CRF also displayed posters and demonstrations from
researchers.
The Bipolar Research Clinic, a specialist clinic led by Professor John Geddes now takes
place on the CRF Warneford site. The position of the clinic on the CRF allows ready
access to information and skills to inform patients about research opportunities many of
which are directly relevant to the clinic population.
2.4.5 Training
The Lead R&D Nurse, Cindy Whitbread, and Research Governance Manager, Victoria
Rush for Oxford Health NHS FT have embarked on a Leadership and Management
accredited course at the University of Oxford Said Business School. The course has been
arranged and funded by the Oxford CLAHRC
Occupational Therapists in the region have been trained in using the Oxford Cognitive
Screen, developed with CRF support, and we have had over 120 downloads of the screen
from NHS practitioners. The screen has been adopted in Hong Kong, Italy, Germany,
Spain and Brazil, none of which would have taken place without support from the NIHR
CRF. In addition, Dr Nele Demeyere, who has been supported by the CRF, has just
gained a Stroke Association Lord Leonard and Lady Estelle Wolfson Foundation
Lectureship, to forge new translational research into cognitive deficits and recovery after
stroke, enabling us to build even stronger links with practitioners.
All year one research students in our Heidi Johansen-Berg research group attend the
FMRIB Graduate Training Course - a series of lectures, tutorials, and hands-on practical
sessions to teach students about neuroimaging data acquisition and analysis.
The Plasticity Group at FMRIB runs a quarterly Skills Training Programme. This involves
one half day session, and provides trainees with training in skills related to clinical
Page 21 of 41
PUBLIC
research, including reviewing a paper, responding to reviews, interview skills, and
presentation skills.
2.4.6 Links with Industry

CRF staff have met with Covance (CRO) to discuss collaboration to increase
competitiveness/attractiveness of UK to industry.

We are working with Roche (via Profs Catherine Harmer and Guy Goodwin) to
develop experimental medicine models for bipolar disorder.

We (Lovestone/Geddes/Hinds/Gallacher) are working with Apple to develop widely
applicable apps (using ResearchKit) to provide sensitive measures of cognitive
function and mood for use in early phase and adaptive clinical trials in mood
disorder and dementia

Professor Glyn Humphreys is leading interactions with P1vital, Arctic Shores and
Ounce technology.

In addition the CRF at the Warneford site continues to work with P1Vital to support
the delivery of the third study

During 2014/15 we have worked with 3 UK Small and Medium Enterprises (SMEs),
although it is recognised that is an area for improvement
New strategic partnerships between your NIHR CRF and industry during financial
year 2014/15

Professor Glyn Humphreys is collaborating with P1vital on the EU initial training
Network where they are one of our partners – developing new assessments of
attention. The team are also collaborating with a gaming company, Artic Shores, in
developing new game-like cognitive assessments. Tests designed in collaboration
with them are currently being piloted on our stroke population.

There are collaborating with Isis Innovations to roll out the Oxford Cognitive Screen
we have developed under the CRF. We have had 120 uptakes of the OCS from the
Isis website.

In addition there are collaborations with Ounce Technology who are developing a
new tablet neuropsychology test we have designed – termed COAST – for
application in the NHS (Wellcome Trust funding). We are currently piloting a beta
test version.

The CRF at the Warneford site is heavily involved in the undertaking of highly
complex Phase III clinical trials that would not have provided an opportunity for the
NHS organisation to routinely host due to a community based service delivery
model. The CRF has been essential in supporting such research
Key examples of studies active in financial year 2014/15
Page 22 of 41
PUBLIC

The CRF has undertaken 12 commercial contract research studies

The EU Initial training Network in collaboration with P1vital is in the progress of
developing and applying new tests of attention and new computer-based
rehabilitation strategies to enhance the diagnosis and treatment of attention
problems.

The Wellcome Trust funding for the development of COAST with Ounce
Technology as a collaborative partner
2.4.7 Links with Other NIHR Infrastructure
The Head of R&D/Senior Manager (Emma Stratful) of the CRF took over the project
management role of the NIHR funded D-CRIS implementation for Oxford Health NHSFT
CRIS partner in October 2014. CRIS - Case-Records-Interactive-Search is an application
that allows interrogation of the Electronic Health Record, strips all patient identifiable
information and allows researchers to generate data from a searchable repository hosted
by SLaM. CRIS was developed originally at South London and Maudesley Trust (SLaM)
with the aim of including four further partner trusts to generate powerful potential for
outcomes based research in a real life situation. The system has proven efficacy as the
CRIS output from SLaM has resulted in over forty peer reviewed primary research
publications. Through appropriate leadership the project has progressed significantly and
has been submitted for ethical review. If approval is gained CRIS will be a very valuable
asset in progressing research including that carried out on the CRF.
The Oxford AHSC Theme 6 – Cognitive Health: Maintaining Cognitive function in health
and disease, continues to build research capacity in dementia and cognitive health and
provided integration between Universities and the NHS Trusts, including the Oxford AHSN
(dementia lead – Dr Rupert McShane) and was initially facilitated by the Oxford BRC
Cognitive Health working group. In addition the Oxford CLAHRC, Oxford Dementia and
Ageing Research (OxDARE) was created as a vehicle to coordinate dementia research
and translation across Oxford. Both the working group and its various projects continue to
benefit from the NIHR CRF, bringing together Oxford Health NHS Foundation Trust,
Oxford University Hospitals NHS Trust, and multiple departments of the University of
Oxford (Psychiatry, Experimental Psychology, and Clinical Neurosciences). The facilities
provide the full range of services required for experimental neuroscience, are fully
integrated with the Oxford Biomedical Research Centre
The CHA exercise testing laboratory is integrated into the NIHR Oxford cognitive health
CRF: http://oxford.crf.nihr.ac.uk/the-charles-wolfson-clinical-research-facility;
both Dr
Clare Mackay and Dr Claire Sexton have presented at the NIHR Oxford cognitive health
CRF seminar series this year.
Towards the end of 2014 the Senior Managers from the Oxford BRC, DEC, CLAHRC and
CRN initiated a quarterly meeting to discuss issues and ways of aligning the NIHR
infrastructures within the local area and to increase collaboration
2.4.8 Impact in Healthcare Provision
The Oxford Cognitive Screen is routinely clinically used by Occupational therapists to
measure cognition after stroke
Page 23 of 41
PUBLIC
The OCS is also not being used in large-scale trials internationally – in Hong Kong, South
Africa, Italy and Spain. Here it is being used as a frontline measure of cognitive change in
(respectively) stroke, HIV infection individuals, dementia and traumatic brain injury.
The OCS-care trial has the potential to change NHS practice for measuring cognition after
stroke and for improving outcome by facilitating early diagnosis and intervention and by
providing extra information for patients and carers about the management of their clinical
position.
The OxCADAT team also lead the Oxford AHSN Anxiety & Depression Clinical Network
which covers IAPT services in 12 CCGs. During the last year, one of the main projects has
been to enhance the overall recovery rates for patients with depression and any of the
anxiety disorders who are seen in the local services. The OxCADAT team has provided
regular enhancing recovery workshops for local clinicians and has also conducted
analyses of local and national data to identify predictors of variability in outcome, which
can be used to launch service innovation projects. Over the last 12 months, the recovery
rates observed in IAPT services nationally have averaged 45% with no significant change
between the beginning and end of the year. By contrast, the 12 CCGs covered by our
network have moved from an average recovery rate of 46% to an average of 54%.
Detailed plans are in place to move further forward in the coming year.
The OxCADAT team has played a major role in national lobbying for a further expansion in
the availability of evidence-based psychological therapies for mental health problems. In
the summer, Richard Layard and David Clark published a book entitled "Thrive: The power
of evidence-based psychological therapies" which outlined all the clinical and economic
arguments they had used to argue for the creation of the IAPT programme and explained
the joint benefits of expanding the programme to people with long-term health problems,
severe and enduring mental illness, and children and adolescents. The book attracted
considerable media attention, including interviews on the Today programme and various
television programmes. There was a well-attended parliamentary launch and the main
political parties do appear to have committed to the general direction of travel that is laid
out in Thrive. The Layard and Clark arguments are also gaining some traction overseas.
Sweden has launched some IAPT-like pilot programmes and other countries are
considering doing the same. A special updated North American edition of Thrive will be
published in Princeton University Press at the beginning of September. It is already
attracting favourable publicity among US professional organisations.
2.5
NIHR CRN
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 15 NIHR CRNs will now cover all
therapy areas and allow flexible deployment of resources. Each CRN supports six
divisions:
Division 1:
Division 2:
Division 3:
Division 4:
Cancer
Diabetes, stroke, cardiovascular disease, metabolic and endocrine disorders,
renal disorders
Children, genetics, hematology, reproductive health and childbirth
Dementias and neurodegeneration, mental health, neurological disorders
Page 24 of 41
PUBLIC
Division 5:
Division 6:
Primary care, ageing, health services and delivery research, oral health and
dentistry, public health, musculoskeletal disorders, dermatology
Anesthesia/peri-operative medicine and pain management, critical care,
injuries/emergencies, surgery, ears/nose/throat, infectious diseases/
microbiology, ophthalmology, respiratory disorders, gastroenterology.
Progress continues to grow with the dementias and neurodegeneration specialty of
Division 4 (previously known as DENDRON) with an increase in the number of
expressions of interest being requested, however the Trust is yet to see this converted into
the undertaking of the studies. The Clinical Specialty leads for dementia (Dr Rohan Van
de Putt) and mental health (Dr Andrew Molodynski) have been appointed from clinical
teams within the Trust. CRF continues to support the undertaking of commercial and noncommercial studies being co-ordinated within the field of dementia.
Links are being formed with other Divisional leads (particularly with Division 2 and 5) within
the CRN to potentially undertake more community, non-mental health research and
primary care.
2.6
NIHR BRC and CRF
Work has already started to consider the Biomedical Research Centre (BRC) application
with regular meetings and a planning event timetabled for late July.
The NIHR Clinical Research Facility (CRF) renewal application will be considered in the
near future.
3 Research Governance
3.1
R&D Governance Group
The R&D Governance group is established with a member of each of the clinical
directorates now identified and attending quarterly meetings. The Group serves primarily
as an assurance group to review research ongoing within the Trust.
A summary paper of the R&D Governance Group meetings are submitted to the Quality
Sub Committee: Effectiveness
3.2
Contract Review Processes
The agreement between Oxford Health and Oxford University Hospitals to undertake the
review of non-standard or modified contracts from a legal perspective to ensure the Trust
obligations are appropriate is to be renewed due to the effective working practices this has
demonstrated.
3.3
R&D Data Capture Mechanisms
3.3.1 Expressions of Interest
Commercial companies are continually looking for new NHS sites in which to conduct their
studies. The initial step is to complete an expression of interest which provides key
information about the research servicers that the Trust can offer. If a company requires
further information they will request confidentially agreements to be signed and the Trust
Page 25 of 41
PUBLIC
will undertake a feasibility assessment. In the January report it was mentioned that due to
the high level of requests R&D had adopted the default position of saying yes to all
requests with a more detailed review if the companies request further information and
feasibility. This approach seems to be working well.
3.3.2 Grant Application Process
In the summer of 2014 R&D developed the following grant application process to help
researchers in the completion of funding applications:
1. The Investigator advises R&D of their intension to submit an application a minimum
of 6 weeks prior to the submission deadline
2. R&D will confirm receipt and forward the information to John Geddes (R&D
Director) for approval to proceed in the development of the application
3. The Investigator works with R&D Finance to establish the value of the application
4. The application is considered by the relevant R&D Study Review Panel
5. The completed application is sent to John Geddes (R&D Director) before
submission for final review.
6. The investigator arranges for signatures by the relevant Trust officers prior to
submission.
The process was developed to support researchers in costing for their research
appropriately within the funding body guidelines in a timely manner and to ensure that
deadlines are met.
This process has been followed in the majority of cases however it has recently been
identified that due to the increased variety of number of organisations and types of studies
being submitted through the Trust there is a greater need to review the non-financial
element of applications. It has therefore been agreed to appoint a grants officer, possibly
jointly with the Department of Psychiatry to fill this gap. The advantages of this will include
making investigators aware of funding opportunities, potentially supporting the application
development and a more efficient sign-off process.
3.3.3 Pipeline Meetings
Since the instigation of the pipeline meetings in October 2014 approximately 88 studies
have been reviewed by the group for feasibility; 34 were commercial and 54 noncommercial. Of those approximately 39 have been approved to date with 25 not being
approved, for varying reasons. The intention is to also track the conversion rate of
commercial companies who approach the Trust to undertake research however the data is
not available for this report.
The pipeline meetings have been successful in enabling an overview of proposed research
studies coming to the Trust, both commercial and non-commercial. The system now in
place to review and confirm feasibility has improved the Trust’s ability to support a
speedier set-up and approval for research studies, including grant applications and has
enabled a much more cohesive approach to researchers from the R&D team as a whole.
These will be replaced by new meetings outlined in the new meeting structure outlined
below.
Page 26 of 41
PUBLIC
3.3.4 Health Research Authority (HRA)
A change in role for Trusts will mean that NHS Permission will no longer be issued by
individual Trusts but will now be undertaken by the HRA. This new role will require greater
emphasis on the R&D team to work with researchers ahead of HRA approval by
confirming that there is capacity and capability to deliver and support research within the
Trust and to that end, Pipeline Meetings are in-line with the expectation of the HRA for
Trusts to provide this assurance to sponsors and researchers.
3.3.5 R&D Data Capture
The R&D Governance Manager initiated the redevelopment of a database for the capture
and tracking of research studies and recruitment within the Trust.
The Research Portfolio Management System (RPMS) was originally initiated and
approved by the NIHR and is a database capable of monitoring the lifecycle and
recruitment of a research study. The Research and Development Governance team have
been working directly with Oxford University Hospitals (OUH) to use this system at Oxford
Health (OH) and OUH have agreed to create a standalone system for OH using the RPMS
format.
Migration of the initial data set is in progress and once this is complete the data will be
tested to regarding the migrations success. The RPMS runs on the OXNET server, a
secure NHS server system and a request has been sent to Oxford Health IT Services to
make relevant arrangement for this system to run here at Oxford Health.
We are currently awaiting approval by Oxford Health IT Services regarding the OXNET
server and service level agreements are being set up between Oxford Health and Oxford
University Hospitals. Once the system and service level agreements have been approved
we will be in a position to test the data migration and train the Research and Development
Governance team to use the new system. We would hope that this will be in use by the
end of June.
3.3.6 Monitoring and Auditing of research projects
Due to workload and lack of staffing resource within the R&D governance team it has not
been possible to focus attention to the role-out of a robust monitoring and auditing process
for hosted and sponsored research within the Trust. However, a number of studies have
been identified as requiring a review of governance compliance and the hope is that the
governance team will be able to commence the process of contacting and arranging visits
with individual PIs within the next couple of months.
Trust sponsorship review processes have been strengthened to ensure that Trust
sponsored research is ready for ethical review and approval and to deliver a successful
piece of research.
3.3.7 Safety committee
Following the instigation of the Trial Safety Review Group (TSRG), processes for ensuring
greater Trust oversight of safety for research studies taking place at the Trust are now in
place. The TSRG will commence reviewing SAEs for clinical trials involving investigational
medicinal products (CTIMP) taking place at the Trust. An assessment of safety for each
CTIMP study will confirm which studies should be requested to provide copies of reported
Page 27 of 41
PUBLIC
SAEs to R&D for assessment and onward dissemination to the TSRG. Currently there are
no studies requiring this review but the expectation is that this will increase as new studies
take place at the Trust.
The TSRG will also review any incident that is reported via the monthly Trust Incident
Reports (Safeguard.web@oxfordhealth.nhs.uk). These reports are now being provided to
the R&D governance team who will provide copies of incidents relating to research being
conducted at the Trust.
3.4
New Meeting Structure
Over the past 12 months the number of research queries and requests to host studies
within the NHS organisation has increased considerably and recent issues have arisen
over the decision making processes due to the number of stakeholders both internally and
externally. This has led to tensions between teams and individuals as people are not sure
of processes that are in place, and who is in a position to be able to provide answers,
leading to a variety of emails with too many people copied in and senior manager and
directors being involved where they do not necessarily need to be. Therefore, a new
meeting structure has been developed to streamline processes and decision making
pathways following the flow of information from expressions of interest to set up, through
to conduct and review of progress was not a streamline.
The new structure that is being rolled out and tested over the next six to nine months is
shown below.
Page 28 of 41
PUBLIC
The attendance at the meetings includes the relevant stakeholders in order
comprehensive understanding of any issues of undertaking individual studies can be
addressed with the relevant experts being able to offer insight into solutions. These
meeting will be held on a monthly basis where there will be direct communications to the
right people in the right place.
3.5
R&D Internal Audit
The R&D department was audited this year, 12 months earlier than anticipated due to
change in Trust providers. The final report contains 2 important action points, (1) the need
to maintain a more robust study and database (2) redesign of the monitoring and auditing
process. Both of these concerns had already been identified by R&D and progress on
addressing them is noted above under R&D Data Capture and Monitoring and Auditing of
research projects.
4 Studies and Participant Recruitment
4.1
Studies
The Trust is continually considering (pipeline activity), implementing (awaiting approval)
and running (open) research studies. These vary in size and complexity and are
summarised in the tables below:
Page 29 of 41
PUBLIC
Pipeline Activity (December 2014 – May 2015)
Expression of interest received \ submitted
Feasibility assessments
Rejected internally
Redirected as PIC
Site accepted
Withdrawn
9
3
1
1
9
2
Total
25
Awaiting Approval (as at June 2015)
10
Open Studies (as at June 2015)
Open – recruiting
Open – in follow up
Total
Portfolio
Non-Portfolio
Total
Mental Health
Community
64
23
87
58
29
87
74
13
Total
87
4.2
Participant Recruitment
The participant recruitment to studies is shown in the table below:
2011/2012
2012/2013
2013/2014
2014/2015
2,303
53*
1,822
359
2,763
780
2,167
582
Portfolio
Non portfolio
4.3
Grant applications
During the period December 2014 to May 2015 14 grant applications were submitted, of
which 1 was successful and 1 unsuccessful. We are waiting to be advised of the outcome
of the remaining applications.
In some cases the same application has to be submitted more than once, for example an
outline and then a full submission. The tables below only include each study once:
Source of Application
Trust
Department of Psychiatry
Department of Primary Care
Brookes University
Total
5
4
4
1
14
Page 30 of 41
PUBLIC
Funding organisation
NIHR
The Health Foundation
The Alzheimers Society
MRC (via Cambridge University)
Total
4.4
9
2
2
1
14
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).
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. The Trust has
accountability for delivery of research as the legal entity and cconsistent failure by Trusts
to meet these targets may result in a reduction of up to 5% of Research Capability Funding
to NHS organisations.
The NIHR publish quarterly reports detailing how individual Trusts are meeting the targets
and ranking each Trust. The following tables show the data from these reports.
Performance in Initiating CTs
Q3 2013 2014
Q4 2013 2014
Q1 2014 2015
Q2 20142015
Q3 20142015
Number of trials submitted
12
15
13
10
9
Number of adjusted trials
12
12
8
6
4
% trials excluded from analysis
0
20
38.5
40
55.6
% of adjusted trials meeting
benchmark
75
83.3
100
100
100
League *
4
3
3
3
4
League ranking
NA
9
11
12
3
National ranking
NA
40
41
42
48
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.
Page 31 of 41
PUBLIC
*Leagues at Q3 2014-15
League 1 (153-94 total trials submitted)
League 2 (85-44 total trials submitted)
League 3 (41-16 total trials submitted)
League 4 (9-2 total trials submitted)
Performance in Delivering Commercial CTs
Q3 2013 2014
Q4 20132014
Q1 20142015
Q2 2014 2015
Q3 20142015
Number of trials adjusted
12
12
8
6
4
Minimum number of days for first
recruit (VRA to FP)
9
9
9
9
20
Maximum number of days for first
recruit (VRA to FP)
124
124
70
70
70
4
3
3
3
4
League ranking
NA
NA
NA
3
5
National ranking
NA
NA
NA
5
10
League trust is in
Over the past year the R&D department has made real progress in improving the
performance of the Trust against these metrics.
5 A Recent Research Project Development
IPS light - Refining individual placement and support (IPS) for UK practice and
establishing its cost-effectiveness in a pragmatic, non-inferiority RCT (IPS-LITE
TRIAL)
Background
Individual Placement and Support (IPS) has been repeatedly demonstrated to be the most
effective form of mental health vocational rehabilitation. Its no-discharge policy plus fixed
caseloads, however, makes it expensive to provide. We tested whether introducing a time
limit would significantly alter its clinical and consequently potential cost effectiveness.
Methods
Referrals to an IPS service (RESTORE) were randomly allocated to either standard IPS or
to time limited IPS (IPS-LITE). IPS-LITE subjects were referred back to their mental health
teams if still unemployed at nine months or after four months employment support. The
primary outcome at 18 months was working for one day. Secondary outcomes comprised
other vocational measures plus clinical and social functioning. The differential rate of
discharge were used to calculate a notional increased capacity and to model potential
rates and costs of employment.
Results
123 patients were randomized and data collected on 120 at 18 months. The two groups
(IPS-LITE, 62, IPS, 61) were well matched at baseline. Rates of employment were equal
Page 32 of 41
PUBLIC
at 18 months (IPS-LITE 24, (41%), IPS 27(46%)) at which time 57 (97%) had been
discharged from the IPS-LITE service and 16 (28%) from IPS. Only eleven patients (4
IPS-LITE, 7 IPS) obtained their first employment after nine months. There were no
significant differences in any other outcomes. IPS-LITE discharges generated a potential
capacity increase of 46.5% compared to 12.7% in IPS which would translate into 35.8
returns to work in IPS-LITE compared to 30.6 in IPS over an 18 month period if the rates
remained constant.
Conclusions
IPS-LITE is equally effective to IPS and only minimal extra employment is gained by
persisting beyond nine months. If released capacity is utilized with similar outcomes IPSLITE results in an increase 17% in numbers gaining employment within 18 months
compared to IPS and will increase with prolonged follow up.
Accepted for publication in BJPsych
6 Case Records Interactive Search
The Case Records Interactive Search (CRIS) application takes clinical information from
the local, Oxford Health NHS FT (OHFT) EHR, removes patient identifiable information
and provides searchable and secure access to data for research and audit purposes. The
system allows effective anonymisation and psuedonymisation of data.
CRIS was designed primarily to support three types of usages:
•
•
•
Type 1: as an anonymised database for secondary analysis
Type 2: to identify potential recruits to research projects from the clinical population
Type 3: to provide contextual clinical information for existing research participants
The CRIS Management Group was established to develop key documentation to enable to
Trust to submit an ethics application to enable usage within the Trust for research and
audit purposes. The CRIS Management Group has fulfilled its role and will now morph
into the CRIS Oversight Group who will oversee its usage once ethics approval has been
granted.
The security model and information governance assurance framework documents were
completed in Quarter 1. These were essential documents required for the drafting and
submission of an ethics application. The complete document set was submitted to the
research ethics committee (REC) and a meeting was held on 29th May 2015. A decision is
pending.
The newly appointed CRIS Co-ordinator will develop and roll out training for CRIS and
support the implementation and adoption within the Trust to enhance service delivery and
clinical outcomes.
Page 33 of 41
PUBLIC
7 Finance
In FY15 the Trust received funding of £6,462k to fund its various R&D activities. This
funding is summarised in the table below:
Source
The National Institute for Health Research (NIHR)
Clinical Research Network: Thames Valley and South Midlands (CRN)
Non-NIHR and Commercial Income
Total
FY15 Actual (£k)
4,305
1,500
657
6,462
The NIHR and CRN require the completion of detailed annual returns to ensure all funding
is used appropriately within the year awarded. Any unused funding would need to be
returned to the relevant funding organisation.
7.1
FY15 Performance
The FY15 R&D performance generated a contribution to overheads of £268k which
compared to the budgeted contribution of £126k generated a favourable variance of
£142k. This was made up of a £302k favourable expenditure variance due to delayed
study activity partly off-set by a £160k adverse income variance. The adverse income
variance was a result of reduced study related income required to support the lower
activity levels partly off-set by higher than budgeted non-NIHR income, mainly commercial.
7.2
National Institute for Health Research (NIHR)
The FY15 NIHR Income was made up as follows:
FY15 Actual (£k)
869
247
717
1,250
1,112
89
21
4,305
7.3
Type of Income
Study Income (Trust & Department of Psychiatry)
Study Income (Department of Primary Care)
Clinical Research Facility (CRF)
Collaboration in Leadership in Applied Health Research and Care (CLAHRC)
Research Capability Funding (RCF) Department of Psychiatry \ Trust generated
Research Capability Funding (RCF) Department of Primary Care generated
Research Capability Funding (RCF) CRF funding generated
Total NIHR Income
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 ran 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.
Page 34 of 41
PUBLIC
Senior
(SI)
Investigators
SI Funding (£75k)
Study Income
Rate
Study Related RCF
Total RCF
FY14 Department of
Psychiatry \ Trust
FY15 Department of Psychiatry
(DoP) \ Trust
Keith Hawton, Guy Goodwin,
John Geddes, David Clarke,
Alastair Gray
Keith Hawton, Guy Goodwin, John
Geddes, David Clarke, Alastair
Gray, Charles Vincent, Simon
Lovestone
£0.525m
£1,338m
0.439
£0.587m
£1,112m
£0.375m
£1,592m
0.405
£0.645m
£1,020m
FY15
Department of
Primary Care
(PC)
Sue Ziebland
FY15
Total
£0.075m
£0.600m
£0.015m
£0.090m
£0.602m
£1,202m
£.072m
0.20 ##
## The DEC study in seen as a Centre and attracts a different RCF weighting
The table below shows how the FY15 Department of Psychiatry and Trust RCF allocation
was utilized:
FY15 RCF (£k)
Trust
University
Total
289
823
1,112
The research-related component of an NIHR Faculty member’s salary, which is
not covered by other funding sources
(378)
(399)
(777)
Meeting the cost of the time of Faculty members in preparing grant proposals
(151)
(8)
(159)
The research-related time of NHS-employed scientific, administrative and
secretarial staff who support Faculty members in their NIHR-related work (Includes
the mitigation of the cost pressures occurring due to the NIHR withholding final
study payments)
(36)
(34)
(70)
Accommodation costs, finance management costs, and human resource
management cost incurred in hosting NIHR-funded research
(96)
(10)
(106)
Total
(372)
372
-
FY15 Award
Current commitments by RCF category
The use and allocation of RCF is reviewed on a regular basis by the Director of R&D
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 continued in FY15
but in addition individuals were invited to apply for RCF to support research activities and
as a result 4 applications were successful receiving a total allocation £79k. In FY15 RCF
was also used to the mitigation of the cost pressures occurring due to the NIHR
withholding final study payments (mentioned in more detail under Financial Risks and
Issues).
7.4
FY16 RCF Allocation
The FY16 RCF allocation is £1,410k and was generated from activity within the Trust and
Department of Psychiatry, Department of Primary Care and by the CLAHRC and is
detailed in the table below:
Page 35 of 41
PUBLIC
FY16
Senior
(SI)
Investigators
SI Funding (£75k)
2014 Funding
Department of Psychiatry \ Trust
Keith Hawton, Guy Goodwin, John
Geddes, David Clarke, Charles Vincent,
Simon Lovestone
£0.450m
£1,271m
Department of Primary Care
Sue Ziebland, David Mant,
Trisha Greenhalgh, Andrew
Farmer
£0.300m
£.196m
Study Related RCF
Strategic contribution
Total RCF
CLAHRC
Total
£0.750m
£1.0m
£0.461m
£0.037m
£0.948m
£0.032m
(£0.037m)
£0.295m
£0.166m
£0.660m
£1,410m
£0.166m
The FY16 allocation shows an increase of £208k on the amount awarded for FY15, the
changes are shown in the table below:
Type
Studies
Infrastructure
&
Senior Investigators
Total
FY15 (£k)
FY16 (£k)
Var (£k)
Comments
602
660
58
£166k additional income related to the 2014 CLAHRC funding
partly off-set by lower study income at a reduced funding rate
600
750
150
Three new Senior Investigators (David Mant, Trisha Greenhalgh,
Andrew Farmer) have joined the Trust or changed their associated
NHS organisation and one has been removed (Alastair Gray)
1,202
1,410
208
During FY15 it was highlighted that RCF was potentially at risk of being reduced and the
FY16 has seen a 1p reduction in the study and infrastructure funding rates coupled with a
blanket 10% reduction on the study related element. This had the effect of reducing this
years Trust allocation by £89k (rate £25k, blanket reduction £64k).
Type
Studies
Infrastructure
Senior Investigators
Total
7.5
FY15 Rate
(£k)
521
228
750
1,499
Rate Reduction
-
(£k)
0.01 p
0.01 p
-13
-12
Blanket 10%
Reduction (£k)
-47
-17
-25
-64
FY16 Total
(£k)
461
199
750
1,410
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
performance is detailed in the table below (£k).
Expenditure
NIHR Funding (funding in place until Mar 2017)
CRN: TV SM annual funding
Total Non-NIHR income (detailed below)
Total Income
Contribution to overheads
Margin after CRF accommodation and Finance support
Page 36 of 41
FY15 Budget
FY15 Actual
Variance
(954)
717
204
92
1,013
59
6%
(954)
717
204
177
1,098
144
13%
85
85
85
PUBLIC
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.
7.6
CRF Related non-NIHR Research Study Income
The table below details the research income received from non-NIHR studies taking place
within the CRF during FY15.
Sponsor/Clinical
Research
Organisation
£k
Funding
FLASHYLYTE RO4917838 in stable patients with persistent, predominant
negative symptoms of schizophrenia treated with antipsychotics - Protocol
No. NN25310
Roche
37
Industry
Contract
Interventional randomised, double-blind, parallel-group, placebo-controlled,
exploratory study investigating the effects of LuAA21004 on cognition and
BOLD fMRI signals in subjects remitted from depression and controls
Lundbeck
1
Industry
Contract
26
Industry
Contract
University of Oxford
23
NonCommercial
Takeda
10
Industry
Contract
Sunovion
72
Industry
Contract
University of Oxford
9
NonCommercial
TOTAL
177
Study
Long-term safety and efficacy of ABT-126 in subjects with schizophrenia: a
double blind extension study for subjects completing study M10-855
Stem cells for Biological Assays of Novel drugs and predictive toxicology
(STEMBANCC
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)
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
Antidepressant controlled trial for negative symptoms in schizophrenia
(ACTIONS)
7.7
AbbVie
Clinical Research Network: Thames Valley and South Midlands (CRN)
The FY15 Income from the CRN was £1,500 from which a £73k contribution to overheads
was received. The details of funding are shown in the table below,
Type
FY15 (£k)
Mental Health
530
Dendron and Neurological disorders (Dendron)
Division-wide (Division 4)
Primary Care and Ageing
307
Specialty Leads
390
23
Total
7.8
250
1,500
Financial Risks and Issues
7.8.1 R&D Income Summary FY12-FY17
The level of research funding is predicted to show little movement between FY15 and
FY16 however it is predicted to drop by £515k in FY17 due to reduced RCF following the
Page 37 of 41
PUBLIC
completion of studies. This will reduce the Trusts flexibility and ability to potentially pumpprime certain areas of research.
Source
NIHR
NIHR
NIHR
NIHR
NIHR
NIHR
NIHR
NIHR
NIHR
CRN
Other
7.9
Type
FY14
FY15
FY16
FY17
Study income Department of Psychiatry & Trust
Study income Department of Primary Care
Clinical Research Facility
Collaboration in Leadership in Applied Health Research and Care
(CLAHRC)
RCF - Department of Psychiatry \ Trust
RCF - Department of Primary Care
RCF - CLAHRC
RCF - OUH
RCF
Total NIHR
TVCLRN \ CRN
Non-NIHR Study income
Grand Total
1,786
106
717
250
869
247
717
1,250
59
280
717
2,000
247
717
2,000
1,020
-
1,112
89
166
21
186
4,305
1,500
656
6,461
937
295
320
64
128
4,704
1,362
373
6,439
535
343
3,879
1,992
752
6,623
4,290
1,362
272
5,924
Redundancy Costs
There are a few members of staff employed on studies which are coming to an end. This
could generate redundancy payments which will not be chargeable to the study. These are
being identified and mitigation sought on a case-by-case basis.
7.10 Study Report and Publication dates
A number of studies have or will come to an end between Oct 14 and Mar 15 where the
NIHR contract allows the withholding of the final payments until reports are produced and
published. The effect of this is that costs will be incurred this financial year but not
recovered until future years. Agreement was gained from the DH to fund these pressures
from RCF allowing the final payment to be released in the following year on the condition
that the funding is used for staff. The studies concerned are shown in the table below.
Study
End
Date
Octet
Oct 14
Report submitted Sep 2014
(23)
Funded from RCF
54
Friends
Wheld
Dec 14
Mar 16
(51)
(101)
Funded from RCF
Funded from RCF
25.5
Octext
Dec 14
Report submitted Jan 2015
Report submission expected
post Mar 2016
Report submission estimated
Summer 2015
Report submission expected
Summer 2015
Report submission Summer
2015
(71)
Funded from RCF
71
(14)
University withholding
final invoices
University withholding
final invoices
14
ECT
Sleep
Total
Apr 15
FY15
Pressure
(16)
(276)
Mitigation
FY16
Income
FY17
Income
25.5
101
16
180.5
126.5
7.11 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.
Page 38 of 41
PUBLIC
7.11.1 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.
7.11.2 FY15 Performance
The actual and budgeted expenditure is shown in the table below (£k).
Theme
Theme
Lead
2013/14
Actual
2014/15
Budget
2014/15
Actual
2014/15
Var
2015/16
Budget
2016/17
Budget
2017/18
Budget
2018/19
Budget
Total
Forecast
Expenditure
Better Management
of
Psychiatric
comorbidities
Mike
Sharpe
14
185
161
24
370
373
369
274
1,585
Health Behavior and
Behavioral
Interventions
Sarah
Lamb
38
180
168
12
336
331
342
278
1,505
Early
Intervention
and
Service
Innovation
John
Geddes
16
217
144
73
318
412
348
278
1,589
Patient
SelfManagement
(Chronic Disease)
Richard
McManus
46
295
226
69
380
321
331
209
1,582
Patient experience
and PROMS
Ray
Fitzpatrick
55
216
187
29
346
304
301
232
1,454
Central and Support
Costs
81
157
364
(207)
250
259
309
229
1,285
Total
250
1,250
1,250
0
2,000
2,000
2,000
1,500
9,000
The reported overspend on central and support cost reflects the re-categorisation of
expenditure relating to Health Economics and Statistician support which was budgeted by
theme but ultimately charged centrally. The Early Intervention and Service Innovation did
underspend due to staff recruitment slippage but the underspend was utilised by
unbudgeted additional central and support costs
7.11.3 Quarterly Reviews
Quarterly review meetings take place between the CLAHRC Manager, Head of R&D
finance and the theme leads to review spend to date and agree the forecast activity to
ensure total expenditure remains within the financial envelope available. To support this
and to monitor performance monthly reports have been developed and are circulated to
theme leads to.
7.11.4 Matched Funding
A fundamental requirement of the CLAHRC is the need to demonstrate matched funding
committed by other organisations which is linked to CLAHRC activities. In total this needs
to be at least to the same level as the NIHR funding. Matched funding provides resources
to support the proposed themes of research, implementation or a mix of both. Identification
Page 39 of 41
PUBLIC
of Matched funding is an on-going process involving the CLAHRC Manager and the Head
of R&D Finance. Based on current information the amounts shown in the application and
the minimum required by the NIHR have been identified.
2013/14
2014/15
2015/16
2016/17
2017/18
2018/19
Total
Matched Funding identified
525
2,000
3,252
1.747
1.733
1,173
10,430
Minimum required by the NIHR
250
1,250
2,000
2,000
2,000
1,500
9,000
Included within the application
519
2,075
2,077
2,078
2,075
1,607
10,431
Matched Funding (£k)
7.12 Oxford Academic Health Science Network (OAHSN)
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
and is, therefore included for completeness. The three networks are budgeted and
forecast to breakeven the only concern is the £35k Partnerships fees which the Trust has
incurred but didn’t budget for causing an adverse variance.
Network
Lead
Total Award
End Date
Dementia
Dr Rupert McShane
£270k
March 2016
Early Intervention in MH
Prof Belinda Lennox
£210k
March 2016
Prof David Clark
£220k
March 2016
Anxiety & Depression
8 Estates
The R&D department relocated offices in February to the main hospital building at the
Warneford. This has reunited the team into two locations (New office and CRF) and is
improving communications and working relationships with the R&D teams. In addition the
CRN based staff working within the Trust have been allocated office space next to the
R&D department and a move is imminent. This will harness closer working relationships
with the CRN in research study delivery.
9 Staffing
A CRIS Co-ordinator has been appointed to oversee the implementation of the system
within the Trust. The post holder will develop training material for auditors and
researchers using the system and provide support in using the CRIS and manage the
CRIS Oversight Group.
The R&D department had recruited a part time Communications Manager to a joint post
with the University of Oxford, Department of Psychiatry. The post holder will hold a
substantive contract with the University and support the communication of R&D within the
Page 40 of 41
PUBLIC
Trust including developing and maintaining the R&D website. The post holder starts in
July 2015.
There has been a turnover of nursing staff.
10 Communications
Work is continuing with the Trust R&D website with the outsourcing of the building of it due
to limited resource and expertise. The new Communications Manager, appointed through
the University of Oxford, department of Psychiatry will support this venture going forward.
Authors and Title: Professor John Geddes, Emma Stratful & Dr Clive Meux
Lead Executive Director: Dr Clive Meux
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
Page 41 of 41