Pre-Funding Research Feasibility Assessments
What is the Pre-Funding Research Feasibility Assessment?
The CRNCC and NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) are working together to introduce a pre-funding research feasibility review to the NIHR
funding application process to specifically review whether a research proposal is feasible to deliver within the NHS and wider health and care settings.
A process has been designed to utilise the CRN Study Support Service to create a Research Feasibility Assessment Report which will be included by study teams as part of their research funding application. Once the grant application is submitted a CRN Health or Care Leader (initially National and Local Specialty Research Leads) will be asked to provide a peer review addressing the feasibility of the study, as part of the standard peer review process.
Why are we doing this?
During the NIHR Research Reset Programme, it came to light that:
41% of studies were recruiting at a lower rate than expected
20% of studies at that time had no recruitment in the proceeding 6 months, excluding rare disease studies
In addition, it was noted historically that ~80% of studies required extensions (either no-cost or costed).
Clinical studies unable to meet their recruitment targets and / or attain their primary end points raises ethical concerns in terms of patient or public participation. Additionally, it can result in a significantly waste of time and financial resources that could have been redirected toward other research endeavours.
The Pre-Funding Research Feasibility Assessment Project was devised for the CRN health and care community to undertake a peer review of grant applications from the perspective of whether the clinical studies proposed are feasible to deliver in the current health and care environment.
The primary objectives of the Research Feasibility Assessment is to promote early-stage discussions, ensuring that studies are designed with the deliverability of the study in mind right from the beginning. Ultimately aiming to ensure that studies can be successfully completed by emphasising the importance of early proactive conversations.
Who has been involved in this project?
The CRNCC Medical Directorate Office has worked closely with colleagues from across the LCRNs, wider NIHR and Devolved Administrations on this project. A large Advisory Group, supported by a smaller Design Working Group, have overseen the design and development of the proposed process. Membership of the groups has come from:
CRNCC:
Medical Directorate
Business Development and Marketing Directorate feasibility and start-up teams
Research Delivery Directorate non-commercial initiatives and research leads
Business Intelligence team
NETSCC:
Research programmes team
Applications and funding team
LCRNs: East of England, Greater Manchester, Kent, Surrey and Sussex, North Thames, Thames Valley and South Midlands, West Midlands, West of England
All Devolved Administrations
National Specialty Leads from multiple specialties
We would like to thank everyone involved for their input and advice.
Overview of the Initial 2 Pilots:
The first, soft pilot was applied to three HTA commissioned calls whose Stage 2 application period opened in May 2023:
22/150 Intravesical treatments for recurrent urinary tract infection (rUTI) in women
22/157 Interventions to reduce hospital-based medication administration errors
5 applications progressed to Stage 2 of the calls, which were reviewed in August prior to the funding committee meeting in September 2023.
Pilot 2 was applied to three HTA investigator led calls whose Stage 2 application period opened in November 2023.
Both of the initial pilots were completed successfully, showcasing that the Research Feasibility Assessment can be conducted without disrupting the current peer review process. We are grateful to the reviewers, panel members, LCRNs and Study Teams for their participation and feedback, which has been taken into consideration for the next stage of the project.
Overview of Pilot 3:
A further pilot will be conducted on a larger number of studies to assess scalability of the process and to understand whether the Research Feasibility Assessment can be completed on an either researcher-led funding call. Pilot 3 will be applied to an HTA investigator led as well as a Commissioned call.
Following feedback collated so far, the Study Set-up Delivery Tool (SSUDT) will no longer be used to complete a Feasibility Assessment Report. In addition, nurse and midwife reviewers may be called on to trial their participation as reviewers. This will allow us to see if and how we can increase the number of reviewers in the long run.
NETSCC will inform the CRNCC of the applicants that have been successful in progressing to Stage 2. The CRNCC will then reach out to the relevant Lead LCRNs and Devolved Administrations to let them know that the pilot will be running in their region and to expect the study team to get in touch in order to get a Research Feasibility Assessment Report completed.
LCRNs / DAs involved in the pilot will be provided with the following:
A copy of the correspondence and information regarding the PFFA provided to applicants who have been invited to submit a Stage 2 application
Next steps:
Applicants will have 8 weeks to complete their Stage 2 application. During this time the LCRN will liaise with the Chief Investigator / representative to complete the Research Feasibility Assessment Report.
Following the Stage 2 Submission, the reviewers will use the Research Feasibility Assessment Report, as well as the main funding application, to conduct the Research Feasibility review within 2 weeks, over a 4 week period.
Once the peer review period has closed, a Funding Committee will be held to make a decision on the funding application. Please note that during the pilot phase, the contents of the Research Feasibility Report and peer review will not automatically disqualify any application when evaluated by the funding committee.
What will happen during the pilot?
Prior to the Stage 2 Funding Application Submission:
Chief Investigators or their representatives are requested to contact their Lead Local Clinical Research Network (LCRN) or Devolved Administration representative, to collaboratively complete a Research Feasibility Assessment Report. This report aims to provide key study information and context for the feasibility review, and will need to uploaded as a PDF document along with the Stage 2 application submission.
Post Submission of the Stage 2 Funding Application:
A designated Clinical Research Network (CRN) Feasibility Reviewer will complete a feasibility review of Stage 2 applications, to answer the question: “Is it feasible to deliver the proposed research in the current environment of the NHS and social care?” The reviewers will use both the Research Feasibility Assessment Report and the main grant application to inform their assessments.
This additional review complements the standard peer reviews conducted as part of the funding review procedure. Applicants will have the opportunity to respond to any comments following the feasibility review, as per the standard peer review process. During this pilot phase, it is important to note that the contents of the Research Feasibility Report and peer review will not automatically disqualify any application when evaluated by the funding committee.
How will the project be evaluated?
Evaluations will take place throughout the process to review:
The time taken to source reviewers
The ease of completing the Research Feasibility Assessment Report for applicants, DAs and LCRNs
The time taken to complete the Research Feasibility Assessment Report
The usefulness of conducting the Research Feasibility Assessment from an applicant perspective
The usefulness of the Research Feasibility Assessment Report to the reviewer
The time taken to complete the peer review
The usefulness of the review to the funding panel
What should I do if I have any questions?
A number of resources have been created to provide extra information:
this slide-deck presentation gives an overview of the project as a whole
you can watch a recording of a presentation covering the peer review element of the process, or view the slide-deck used here
you can watch a recording of the PFFA: Nurse and Midwife Reviewer training webinar by clicking here
If you have any other questions, please reach out to pffa@nihr.ac.uk.