Research Design Service London

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1 Research Design Service London Enabling Better Research Peter Lovell Programme Manager 27 th October 2011

2 Overview of presentation An introduction to the NIHR Research Design Service (RDS) Outline of the support that we can provide Summaries of NIHR funding opportunities

3 Research Design Service (RDS) What are they? National network of support services, each region (SHA) has its own RDS Funded by the Department of Health Part of the National Institute for Health Research (NIHR) Set up to increase the number of high quality grant applications for applied, people focused health and social care research

4 Research Design Service (RDS) Why are they needed? For NIHR applications, typically 1 in 10 are successful!! Proposal is out of scope (basic/ laboratory research / knowledge generation) Failure to demonstrate the importance of the topic Insufficient case made for patient benefit (pathway needs to be well described) Lack of clarity (committee members have a wide range of backgrounds) Proposed methods are unsuitable, flawed or unlikely to yield results Gaps within the research team (need appropriate methodological expertise) Inadequate attention to PPI (present evidence of appropriate input)

5 Research Design Service London Who are RDS London? Partnership between four academic institutions

6 Our structure and expertise RDS London Steering Group RDS London Core Team Senior Research Advisers College based experts Develop strategy, monitoring progress Delivery of the service, outreach, communications, administration, PPI Deconstruct proposals, identify issues, define way forward Statisticians, Health Economists Qualitative researchers, Social Scientists.

7 Research Design Service London How can we help? Publish research results Identify research area The Research Cycle Design research study RDS INPUT AT EARLY STAGES Analyse research results Carry out research

8 How can we help? Research Design Service London Can provide advice and guidance on research design Design research study SUPPORTING those who are submitting grant applications to national peer reviewed funding competitions FOCUS: NIHR schemes.

9 Our mission: Research Design Service London Provide practical advice and guidance Help increase the quality of grant applications Achieve greater success in attracting funding

10 Research Design Service When should I get in touch? 6 months prior to submission: Projects in their infancy 8 weeks prior to submission: More developed projects 4 weeks prior to submission : Absolute minimum

11 Initial appraisal Delivering the service Specialist advice and guidance Facilitate additional support Evidence / rationale reviewed Importance / quality / focus of the research question Positioning of the proposed study Broad feedback on study design, methods, outcomes chosen Potential for PPI Within scope of targeted funding stream Suitable team Primary Care Secondary Care Specialist help in trial design Statistics Qualitative methods Health Economics PPI R&D offices Clinical Trials Units MAST CLRN Meetings with patient groups Tertiary care

12 Public and Patient Involvement (PPI) Important component of NIHR funding applications Improve relevance of research Provide advice and guidance on appropriate levels of involvement. Facilitate dissemination of results PPI Outcomes are patient focused Enabling Involvement Fund launched April 2010 Facilitate links between researchers and public / patient groups. Improve recruitment Aid in study design

13 ... a key part of the network Integrated into our host institutions access to a wide range of expertise Formed links with established research networks and NHS Trusts Connect clinicians with academics, researchers with service users Good working relations with funding programme managers / attend funding committee meetings Bridge the gap between researchers and funding bodies

14 Access to the service website / online support request form website: drop-in sessions clinics

15

16 RDS London will not... Write proposals for researchers Provide formal training for researchers Respond to unreasonably late requests for support Work miracles!

17 Some of the successes in London... NIHR Research for Patient Benefit (17 awards) NIHR Programme Grants for Applied Research (5 awards) NIHR Efficacy and Mechanism Evaluation (2 awards) NIHR Innovation for Invention (4 awards) NIHR Health Technology Assessment (4 award) NIHR Service Delivery and Organisation (5 award) DH Policy Research Programme (2 awards) NIHR Fellowship (11 awards) MRC (3 awards) Charity (10 awards) Supported 82 successful proposals to date 27 million

18 Research Design Service London

19 NIHR Funding Programmes

20 National Institute for Health Research INVENTION EVALUATION ADOPTION DIFFUSION Basic Research Development Pathway Funding Efficacy & Mechanism Evaluation MRC Invention for Innovation Biomedical Research Centres Biomedical Research Units Patient Safety Quality Res Centres Research for Innovation, Speculation & Creativity Research for Patient Benefit Health Services Research Programme Grants for Applied Research Public Health Research Service Delivery & Organisation Health Technology Assessment Collabs for Ldrshp in Appl Hlth Res and Care National Institute for Health Research Programmes / infrastructure to: Develop innovation Evaluate efficacy Examine effectiveness Focus on high priority areas for NHS Deliver improved services Patient benefit in short/medium term

21 Medical Research Council (MRC) Developmental Pathway Funding Stream (DPFS) -supports the pre-clinical development of novel therapies, interventions and diagnostics. Developmental Clinical Studies (DCS) -early stage clinical studies which are on the development pathway for a new therapeutic/ diagnostic/ device/ intervention aimed at proof of concept. MRC / NIHR MRC and NIHR Funding Programmes Efficacy and Mechanism Evaluation (EME) KEY FACTS: EME Response / themed calls Annual budget: 15m Max award: not fixed Duration: not fixed 3 competitions per year

22 Evaluates Technology Outcomes Mechanistic DCS / EME Funding Programmes DCS Early clinical studies. Safety / Proof of Concept in humans A new intervention or a new indication for an existing intervention PoC in humans, surrogates OK, safety Not a focus, can be opportunistic EME Clinical efficacy under controlled conditions (PoC already achieved). Dose / intensity decided. Mostly developed, but some refinement may still be needed Validated surrogates OK (which are indicators of health outcomes). Provide justification for a pragmatic trial. Can include a mechanistic evaluation especially when it aids understanding of how intervention works. Diagnostics Development Validation of a diagnostic

23 Health Technology Assessment (HTA) Evaluates a wide range of technologies delivered within the NHS Supports projects which study effectiveness, cost effectiveness (Phase III/IV) Often a pragmatic multi centre RCT with comparator (best active / usual care) Key requirements: Problem being addressed is important to patients / NHS Rationale / need is based on evidence (systematic review) Fully defined and developed technology Outcomes matter to patients / measure health gain Participants represent the case mix in NHS KEY FACTS: HTA Response / themed calls Annual budget: 88m Max award: not fixed Duration: not fixed 4 competitions per year

24 Evaluates Number of participants Technology eg drugs, tests, devices) Outcomes Design Health economic component EME or HTA programme? EME Efficacy under ideal conditions Small large, single or multi centred Mostly developed, may still require fine-tuning Surrogate markers are acceptable Clinical trial or evaluative study Not usually HTA Effectiveness in an real life NHS setting Generally large, multi centred Fully defined and developed Clinically important outcomes that measure health gain Often a randomised controlled trial Usual Mechanistic study Can be included Not usually considered

25 Research for Patient Benefit (RfPB) Funds projects which are regionally focused; often derived from day-to-day practice; informed by NHS patients and service users; likely to have an impact /patient benefit (or has a well defined pathway to patient benefit) Evaluate the effectiveness / cost effectiveness of interventions Studies which encompass feasibility / pilot trials are in scope (that then require a major grant application to another funder). KEY FACTS: RfPB Response mode Annual budget: 25m Max award: 250K Duration: up to 3yrs 3 competitions per year

26 NIHR RfPB

27 Innovation for Invention (i4i) Funds research to help turn inventive ideas (medical devices, implantable devices, in vitro diagnostic devices, develop a technology from another sector) into new products to meet a healthcare need. i4i Early stage product development awards: 1-3 year investigation involving a collaboration between industry / academic / clinical researchers to carry out feasibility or pilot studies that support the development of technology. Prototype products should emerge. i4i Late stage product development awards: 1-3 year collaborative project, provide evidence of a capability to deliver improved healthcare and a commercial opportunity. An advanced prototype should emerge, along with plans for commercial exploitation.

28 NIHR i4i

29 Public Health Research (PHR) Main focus is on evaluating effectiveness / cost effectiveness of public health interventions which are delivered outside of the NHS (complementary to HTA) Provide knowledge on the costs, benefits, acceptability of non-nhs interventions to improve the health of the public, prevent disease and reduce inequalities. Topics related to health protection may also be addressed KEY FACTS: PHR Response / themed calls Annual budget: 10m Max award: not fixed Duration: not fixed 3 competitions per year

30 Programme Grants for Applied Research (PGfAR) Provide funding for a programmeof applied research (projects / workpackages linked with a clear theme, where combination gives added value) Provide some stability of funding to a well balanced NHS / academic team. Lead applicant and associated team who have a record of achievement / leadership in applied health research Research priority areas for the NHS / focus on conditions causing a significant disease burden. Research will provide benefits in 3-5 years (and also interim) Fund health service / public health research, economic evaluations and modelling. Developmental work (at least 30%), evaluation expected. KEY FACTS: PGfAR Response mode Annual budget: 75m Max award: 2m Duration: up to 5yrs 2 competitions per year

31 NIHR PGfAR

32 Health Services Research (HSR) Provides funding for a broad range of health services research with the aim of improving service quality and patient safety. HSR will fund projects on: Primary research or evidence synthesis Applied methodology research Cultural and organisational issues around patient safety Knowledge transfer within organisations Measurement of quality improvement KEY FACTS: HSR Response mode Annual budget: 5m Max award: not fixed Duration: not fixed 2 competitions per year

33 Service Delivery and Organisation (SDO) Funds research on the way that health services are organised & delivered Generate research evidence for improving services -to increase the quality of patient care, ensure better outcomes. Allow those who manage, organise and deliver service to carry out research (capacity building) KEY FACTS: SDO Response / themed calls Annual budget: 11m Max award: not fixed Duration: not fixed 2 competitions per year

34 NIHR SDO

35 Summary Provide support to researchers throughout grant application Offer a wide range of expertise Committed to meaningful Patient and Public Involvement Focus on NIHR, but support all funding streams Can we help?? Please contact us as early as possible.

36 NIHR Research Design Service London website:

NIHR Research Design Service London Dr Peter Lovell Deputy Director

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