Transcript Successful research applications

Successful Grant Applications
Professor David Armstrong
Dr Angie Borzychowski
Research for Patient Benefit Programme
10 November 2014
8th Annual NIHR Trainees Meeting
Successful grant applications
• NIHR Research for Patient Benefit programme
• Things to keep in mind when preparing an
application for funding
• Application and assessment process
• Common areas of feedback to applicants
• Opportunities for trainees
• Design a research study
The central role of NIHR research in the innovation pathway
INVENTION
Medical
Research
Council
EVALUATION
ADOPTION
DIFFUSION
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
National Institute for Health & Clinical Excellence
Support for Procurement
Guidance on Health & Healthcare
Access to Evidence
NHS Evidence
Innovation
Academic Health Science Networks
NHS Commissioning Board and Clinical Commissioning Groups
Commissioning
Providers of NHS Services
Patient Care
Applying for research funding
- Know your target
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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?
Research for Patient Benefit
• 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
Research for Patient Benefit
• Response-mode funding programme for small grants
• Maximum award £350,000 for up to three years
• Awards made to NHS bodies and other providers of NHS
services in England
• Collaboration with academic partners welcome
• Ten Regional Advisory Committees and a
national Programme Director
• Three funding competitions per year
• Single stage application process
• > 650 awards totalling over £120 million
• Links with Research Design Services
Research for Patient Benefit
Spend across health category
(2013-2014)
Stroke
7%
Cancer
10%
Cardiovascular
7%
Renal and Urogenital
5%
Generic Health
Relevance
6%
Oral and
Gastrointestinal
6%
Neurological
7%
Mental Health
20%
RfPB funded research information
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
• 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
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)
Guidance: Attributing the costs of health and social care Research &
Development (AcoRD) – updated 4 May 2012
Plain English Summary
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New INVOLVE guidance for NIHR funded research
NIHR application form guidance has been updated
Additional resources to support researchers
Plain English summary is assessed by external
reviewers and advisory panel members
• Good plain English summary is now a requirement for
funded research
• Does the summary give a clear (and
accurate) explanation of the research?
• If funded, summary published on a variety of websites
Feasibility studies in RfPB
• Feasibility studies are welcome in RfPB
• Represent small scale studies at relatively low cost
that reduce the risk of undertaking a more costly
definitive trial where feasibility evidence is not
supportive
• Small spend: We expect most feasibility studies to
cost up to £250,000 unless there is a good justification
for additional costs
• To facilitate feasibility study transition to definitive
trials, RfPB receives Health Technology Assessment
(HTA) programme comment on feasibility study
applications
RfPB guidance and resources
Funding limits for various research types, in relation to risk
and proximity to patient benefit:
• £350,000 – research that has a clear and close trajectory to
patient benefit (e.g. Clinical trials)
• £250,000 – feasibility study applications
• £150,000 – higher risk studies/further from patient benefit
– Observational studies
– Developing and refining interventions
– Developing new scales or outcome measures
– Exploratory studies (e.g. using qualitative methods)
– Additional follow up of patients in a completed trial
– Post-market surveillance for unknown side-effects
– Systematic reviews
RfPB Application Process
•12 weeks to submit
•Online submission and
validation, declarations
•Preliminary scrutiny
assessment for scope/
admininstrative rules
•Notification
•External peer/public
review
•Assessment by full
Regional Committee
•Outcome to applicants
Standard Application Form
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
• Inappropriate statistics or health economics analysis
• Concerns with the recruitment, sampling and overall feasibility
• Questions regarding project impact, timescales, generalisability
or dissemination
Feedback to applicants
Possible reasons for failure
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Failure to meet basic eligibility criteria
Submitting an application which is out of scope
Failure to demonstrate importance of topic
Omission of critical literature references
Failure to demonstrate likelihood of patient benefit
Research question is ill-defined, unfocused or
unsupported by preliminary data
• Research team lacks relevant experience
• Methodology unsuitable or flawed and unlikely to yield
results
Possible reasons for failure
• Insufficient methodological detail to convince
reviewers that the team knows what it is doing
• Overambitious research plan
• Insufficient recognition of potential problems
• Limited access to appropriate patient population
• Research team has too little time to devote to project
• Lack of appropriate patient and public involvement
• Lack of a convincing dissemination plan
• Failure to justify resources
www.nihr.ac.uk
Opportunities for Trainees
• RfPB welcomes applications from junior
researchers, supported by strong team
• Ways to better understand the application
and assessment process:
– Taking part in peer review for RfPB (and other
funding programmes)
– Opportunities to observe RfPB regional advisory
committee meetings
Further support available
• Resources available:
www.nihr.ac.uk/rfpb
www.nihr.ac.uk or [email protected]
• Email enquires: [email protected]
• CCF helpline: 0208 843 8000
• NIHR Research Design Services
(RDS) in ten regions across England
• Funding opportunities leaflet – for
research and career development
21/07/2015
Questions?
21/07/2015
Design a research study
• Everyone:
Write down two areas of research interest
Design a research study
• Everyone:
Now write down up to two research questions
for each area
• They should be in the form of questions
• They should be answerable
• They should be ‘original’, if possible
Design a research study
In trios:
• Share your questions
• Identify the ‘best’ for going forward
Describe an appropriate method:
• Design (if standard); population; sampling
method; intervention (if any); measures;
(statistical powering); analysis plan
Design a research study
In trios: e.g.
Design: clinical trial
Population: patients with Type II diabetes
Sampling: attending surgeries in Leeds
Intervention: 75mg aspirin daily v placebo
Measures: HbA1c at 6 months
(Statistical powering):
Analysis plan: compare HbA1c levels in both arms
Assessing research applications
Main assessment:
1. Is the question worth answering?
2. Will the methods provide an (unbiased)
answer?
3. Can the team deliver?
4. Is it value-for-money?
5. Are patients/public appropriately involved?
Assessing research applications
1. Is the question worth answering?
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Is it ‘timely’?
a) The results from the research might not emerge
for 4-5 years
b) Then they might be synthesised with other
results
c) Will the new knowledge still be wanted?
Assessing research applications
1. Is the question worth answering?
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Is it ‘original’?
a) Research questions can be too original
– Effect of moon phases on arthritis; presence of bug in
stomach wall; etc
b) Research questions can be too derivative
– Effect of insulin on diabetes in women age 40-45 in
Leeds
Assessing research applications
1. Is the question worth answering?
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Is it ‘plausible’?
a) The answer to research question may not be
plausible, especially in terms of the effect size
– The effect of counselling for depression is unlikely to
be 80% better than anti-depressants
Assessing research applications
2. Will the methods provide an (unbiased)
answer?
a) The highest risk is a project that will not answer
the question or provide a ‘wrong’ answer
b) Guard against this by good design (control group,
randomisation, etc)
c) Ensure there are sufficient numbers to identify
the specified effect size
d) Provide evidence that patients can be recruited
Assessing research applications
3. Can the team deliver?
• Does the team cover the skills necessary to
deliver the project?
• Do team members have appropriate time
allocations?
Assessing research applications
4. Is it value-for-money?
Cost your project:
Staff: who and how much time each?
[Prof £80-100k; SL £60k; Lect £40k; RA £30k pa
Add 30% for NI/pension, etc; then add 50% for FEC]
Equipment (e.g. computer):
Consumables:
Travel:
Conferences:
Assessing research applications
4. Is it value-for-money?
1. Does total cost look reasonable?
2. Are there any ‘extravagances’ in costs?
3. Is it worth paying this amount to answer the
question……?
Assessing research applications
5. Are patients appropriately involved?
• Many funders expect patient involvement
• Patient and public involvement (PPI) can
improve your application
• Many funding committees have public review
and PPI members whose views will be counted
Assessing research applications
The funding decision
• All committee members receive application
form and reviewers’ comments
• Two members present the application
including strengths and weaknesses
• Committee members score after discussion
• Highest scores funded
• Usually conditional funding
Completing the application form
Abstract: should there be a plain English AND
scientific abstract?
Aims/objectives: clear, numbered, corresponding to
numbering in methods
Background: stress timeliness, originality and
plausibility
Method: Clear steps, addressing aims/objectives;
remember power calculation to justify numbers (is
the effect size plausible?)
Finances: well justified
• Resources available:
www.nihr.ac.uk/rfpb
www.nihr.ac.uk/funding
• Guidance documents and FAQs
• NIHR Research Design Services (RDS)
• CCF helpline: 0208 843 8000
21/07/2015