1. Research for Patient Benefit Programme
Samantha Wade, Senior Programme Manager
RDS EM Funder Presentation – 15 November2016

2. Overview NIHR Research for Patient Benefit
Programme remit
Funding limits
Application process
Preparing a research proposal
Common areas of feedback to applicants
Things to keep in mind when applying
Plain English summary guidelines
Costing applications

3. The central role of NIHR research in the innovation pathway
INVENTION
EVALUATION
ADOPTION
DIFFUSION
Medical
Research
Council
Basic Research
Development Pathway Funding
Efficacy & Mechanism Evaluation
Invention for Innovation
Biomedical Research Centres
Biomedical Research Units
This pathway covers the full range of interventions - pharmaceuticals, biologicals, biotechnologies, procedures, therapies and practices - for the full range of health and health care delivery - prevention, detection, diagnosis, prognosis, treatment, care.
Patient Safety Translational Research Centres
Clinical Research Facilities
Experimental Cancer Medicine Centres
Research Schools
Research for Patient Benefit
National Institute for Health Research
Public Health Research
Programme Grants for Applied Research
Health Services and Delivery Research
Health Technology Assessment
Centre for Surgical Reconstruction & Microbiology
Collaborations for Leadership in Applied Health
Research and Care
Horizon Scanning Centre
Centre for Reviews & Dissemination, Cochrane, TARs
NHS Supply Chain
Support for Procurement
National Institute for Health & Clinical Excellence
Guidance on Health & Healthcare
NHS Evidence
Access to Evidence
Academic Health Science Networks
Innovation
NHS Commissioning Board and Clinical Commissioning Groups
Commissioning
Providers of NHS Services
Patient Care

4. The RfPB Programme National response-mode funding programme
Applications assessed by eight Regional Advisory Panels
Support individual projects up to £350k and up to 36 months
Funding is made to providers of NHS services in England working in collaboration with appropriate academic partners
Two-stage assessment process
Three competitions per year and participation in NIHR themed calls

5. East Midlands region Chair: Dr Heather Fortnum
Programme Manager: Kathryn Rumney
Project portfolio of 55 projects funded to date totalling £11.5 million
EM success rate of 19% (peer reviewed applications)

6. Selection Criteria
Supports high quality investigator-led research projects that address issues of importance to the NHS
Supports qualitative or quantitative research that could:
Study the way NHS services are provided and used
Evaluate whether interventions are effective and provide value for money
Examine whether alternative means for providing healthcare would be more effective
Formally assess innovations and developments in healthcare
Assess feasibility of projects requiring major applications to other funders

7. Funding limits guidance
Introduction of three funding tiers that aim to balance the probability of a proposal achieving patient benefit against its cost. 
Upper limit of £350,000 for research with a clear and close trajectory to patient benefit
Soft ceiling of £250,000 for feasibility studies (in exceptional circumstances a well argued application could cost more)
RfPB will also now consider research that is ‘higher risk’ (further from patient benefit), but should cost less than £150,000 (exceptions for proposals that might have more immediate patient impact can be made)

8. Examples of £150,000 projects Observational studies
Developing and refining interventions
Developing new scales or outcome measures
Exploratory studies that might provide insights into an intractable problem
Additional follow up of patients in a completed clinical trial
Post-market surveillance for unknown side-effects of a drug (Phase IV trials)
Systematic reviews where the number of relevant studies is likely to be limited

9. 9

10. RfPB Spend 2015-2016 Stroke 5% Respiratory 6% Cancer 14%
Reproductive Health and Childbirth 3%
Cardiovascular %
Renal and Urogenital %
Oral and Gastrointestinal %
Generic Health Relevance %
Infection 4%
Neurological 7%
Musculoskeletal %
Mental Health 20%

11. A renewed RfPB
Two changes introduced from January 2016 (Competition 28)
Ten Regional Advisory Committees reduced to 8 Regional Advisory Panels (‘Panels’ to ensure consistent naming across NIHR) by merging regions
A new Stage 1 formative assessment to triage weak applications and offer advice/support to other applicants

12. Regional Advisory Panels
Ten regions Eight regions

13. Regional Advisory Panels
Merging of smaller regions for administrative efficiency
South East Coast and South Central to merge:
South East and Central
Yorkshire and The Humber and North East to merge:
Yorkshire and North East

14. Two stage application process
NIHR Standard Application Form (SAF) burdensome for ‘smaller’ RfPB grants
Stage 1:
Complete main sections of SAF for a formative assessment by Panel
Stage 2:
If invited, revise and complete rest of SAF for a summative assessment

15. Stage 1
Panel assesses the main sections of application (no external reviews)
Names of applicants
Background/rationale for study
Research question(s)
Methods
Estimate of costs
Is Panel interested in seeing full application?
What could be done to improve it?

16. Stage 1 Assessment Panel will be primarily looking at the following:
The relevance and importance of the research question, such as is it relevant to patients and the NHS? Patient Benefit
The appropriateness of the methodology; will the proposed methods achieve the stated aims? Does the proposed method imply a burden for patients that is unwarranted? Are the endpoints (such as the outcome measure in a clinical trial) sufficiently patient oriented? Methods and the Team
The amount of improvements required to make any subsequent Stage 2 application competitive.

17. Stage 2
If invited to Stage 2, Stage 1 application copied across to SAF
Applicant revises Stage 1 sections in light of panel comments and completes other sections
Applicants given 6 weeks to complete SAF for current round or defer until next
Stage 2 applications are subject to external review
Stage 2 application assessed by panel

18. PPI Stage 1 – looking at the wider picture Focus on question
Patient burden/experience
Patient relevant outcomes
Stage 2 – focus on the detail of PPI plans

19. Timetable
Details of new processes now available for applicants on website
Competition 31 Stage 1 closes 23 November 2016
Competition 30 Stage 2 closes 30 November 2016
Both sets of applications will be assessed at the January 2017 meeting
Competition 32 Stage 1 opens early December 2016

20. Applying for research funding
Know your target:
What are the aims of the funding scheme?
Am I eligible for support?
How will the application be assessed?
Who will assess the application?
When will the application be assessed?
What is the scale of a typical award?
Who has received previous awards?

21. New Investigators New investigators are encouraged to apply
The team as a whole is assessed
Relatively inexperienced lead applicant with sufficiently experienced and resourced co-applicants is fine
RfPB is a good option for researchers looking for their first grant

22. The costs of R&D in the NHS
Research Costs are the costs of the R&D itself; data collection, analysis and other activities needed to answer the research questions.
Research Costs will be met by the research funder (i.e. RfPB)
NHS Support Costs include the additional patient-related care costs associated with the research, which would end once the R&D activity in question had stopped, even if the patient care service involved continued to be provided.
NHS Support Costs will be met by NHS R&D Support Funding (i.e. Networks)
Treatment Costs are the patient care costs which would continue to be incurred if the patient care service in question continued to be provided after the R&D activity had stopped. Excess Treatment cost is the difference between the total Treatment Costs and the costs of the standard treatment currently provided.
NHS Treatment Costs will be met through commissioning arrangements for patient care (i.e. NHS/contracting organisation)
Misallocation of costs could make the research appear poor value for money

23. RfPB: ‘me too’ applications?
{pick any
population}
men
women
young
old
Manchester
ethnic min.
disabled
etc
{pick any
intervention}
CBT
CBT variant
exercise
etc
{pick any disease}
depression
anxiety
heart dis.
diabetes
etc
effective in
treating ? in Is
The Research One-arm Bandit

24. Common areas for feedback
Detail in the methodology lacking or appropriateness of the design questioned
Overall lack of clarity and focus of the application
Inappropriate outcome measures
Particular areas of expertise lacking in the research team
Insufficient quality of the patient and public involvement
Justification or detail of the intervention lacking
Insufficient detail provided in the background information or omission of critical literature references
Inappropriate statistics or health economics analysis
Concerns with the recruitment, sampling and overall feasibility, including overambitious timeframes
Questions regarding project impact, timescales, generalisability or dissemination

25. Feedback to applicants

26. How can the RDS help?
Highlight changes to the programme when advising applicants or at any workshops
Particularly focus on the research question and the methods when advising (Stage 1)
Advise what would be required at Stage 2 (if invited)
Be ready to provide advice during Stage 2 submissions
Provide feedback to the RfPB team

27. How can RfPB help the RDS?
Programme Managers are happy to take scope queries directly from the RDS or provide further detail on the application process
Application guidance plus Word versions of both the Stage 1 and Stage 2 forms on the RfPB website
Regional Programme Managers can attend away days and workshops etc, if required.

28. Things to keep in mind
All project costs are scrutinised by CCF – particular attention should be paid to NHS support, treatment and excess treatment costs (at stage 2)
Patient and public involvement must be adequately thought through and planned as part of design
Plain English summary should be reviewed by a patient/public representative
Relevance to patients and NHS is important
Read the guidance and website resources
Guidance available for feasibility studies
All deadlines are at 1pm exactly so don’t leave it to the last minute

29. Plain English Summaries
The ‘make it clear’ campaign was launched in May 2014 and a good quality plain English summary is now a requirement for NIHR funding.
New guidance for applicants, reviewers and panels has been developed by INVOLVE and implemented across NIHR to help develop and evaluate good quality plain English summaries
The NIHR standard application form and review forms have been revised
Resources have been developed, including examples to support applicants

30. Finally… Key points for a successful RfPB application
Patient benefit has to be very clear (or path to patient benefit)
Including specifics about the numbers of people affected
Evidence that the question is important to patients/public
Methods must be clear and appropriate
What is the research question?
Will the proposed project answer the research question?
The Team needs to be convincing
Does not need to be the great and the good but needs to have the right expertise; research as well as clinical skills are important
Tiny amounts of time from seniors does not convince the panel project will be delivered

31. Thank you!
Questions?