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 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

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?

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 6

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 8

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 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 16

Feedback to applicants

Possible reasons for failure 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

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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 enquiries@nihr.ac.uk Email enquires: rfpb@nihr-ccf.org.uk CCF helpline: 0208 843 8000 NIHR Research Design Services (RDS) in ten regions across England Funding opportunities leaflet – for research and career development 22/09/2018

Questions? 22/09/2018

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: Is the question worth answering? Will the methods provide an (unbiased) answer? Can the team deliver? Is it value-for-money? Are patients/public appropriately involved?

Assessing research applications Is the question worth answering? Is it ‘timely’? The results from the research might not emerge for 4-5 years Then they might be synthesised with other results Will the new knowledge still be wanted?

Assessing research applications Is the question worth answering? Is it ‘original’? 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 Is the question worth answering? Is it ‘plausible’? 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? The highest risk is a project that will not answer the question or provide a ‘wrong’ answer Guard against this by good design (control group, randomisation, etc) Ensure there are sufficient numbers to identify the specified effect size 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? Does total cost look reasonable? Are there any ‘extravagances’ in costs? 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

Guidance documents and FAQs NIHR Research Design Services (RDS) 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 22/09/2018