Research for Patient Benefit Preparing a research proposal What makes a good proposal? Professor Scott Weich, Panel Chair

Research for Patient Benefit (RfPB) 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? Applying for research funding

Research for Patient Benefit (RfPB) 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

Research for Patient Benefit (RfPB) 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

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

Research for Patient Benefit (RfPB) 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

Research for Patient Benefit (RfPB) Feedback to applicants

Research for Patient Benefit (RfPB) Possible reasons for failure Failure to meet basic eligibility and scope criteria Failure to demonstrate importance of topic or patient benefit Research question is ill-defined, unfocused or unsupported by preliminary data Omission of critical literature references Research team lacks relevant experience or too little time Methodology unsuitable, flawed or unlikely to yield results 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 for Patient Benefit (RfPB) 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

Research for Patient Benefit (RfPB) 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 Plain English Summaries

Research for Patient Benefit (RfPB) Stage 1 Assessment Panel will be primarily looking at the following: 1.The relevance and importance of the research question, such as is it relevant to patients and the NHS? 2.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? 3.Are the endpoints (such as the outcome measure in a clinical trial) sufficiently patient oriented? 4.The amount of improvements required to make any subsequent Stage 2 application competitive.

Questions?