A feasibility review ensures a proposed study has an improved chance of being successfully completed. It considers the tasks and the activities outlined in a clinical research protocol, which describes the patient population, recruitment, trial timeline, study procedures and involvement of human subjects. The aim of a feasibility review is to confirm that the Trust can deliver the study prior to research governance commencing, and should be considered the first step in setting up your project.
Why is a feasibility review required?
Many clinical studies fail to recruit sufficient numbers of participants, which can prevent outcomes from being assessed. This wastes valuable resources and time, and can delay treatments for patients. Conducting feasibility assessments can help to ensure that studies are well designed and likely to deliver to time and to target. The Trust is committed to maximising the efficiency and impact of research and requires the conduct of feasibility assessments prior to research submission.
While there are financial penalties levied by the NIHR and grant awarding bodies for failure to deliver on approved research, there is also the wider moral and ethical issue to consider. Studies that prove unfeasible in practice waste public sector resources, as well as participants’ time – and possibly even risks their safety. Conducting feasability reviews explains more about the process.
There are a number of support services that can help you improve the feasibility of your protocol. Please discuss with the Research Office how to liaise with the following departments and services:
- Departmental Governance meetings
- Unit for Medical Statistics Service
- Research Design Service
- King’s Health Partners Clinical Trials Office
- Clinical Research Facility/Experimental Medicine Building
- Biomedical Research Centre
Patient and Public Involvement (PPI) in research
To ensure that patient benefit is not simply based on the views and opinions of research professionals and clinicians, the Department of Health’s national strategy highlights the importance of involving patients, carers and the public at all stages of the research process as advisors/consultants (as distinct from being recruited participants).
Some departments already have PPI in place. If you wish to find out about existing groups or setting up your own, please contact the Research Office.
Conducting a feasibility review
The Investigator or study team must complete the Trust Feasibility Proforma and seek review and approval at the relevant clinical Research Governance meeting, or approval from the relevant R&I Lead. Please contact the Research Office for information on who to contact.
All new studies, sponsorship requests and grants must have a feasibility review, as the Trust will not provide any authorisations without this first step having been undertaken. Every project is different and so department and leads may have additional questions which will need to be addressed. The review can be conducted in parallel with preparing the study documents and submission.
Submissions will not be accepted until the R&D Lead has confirmed your project is feasible.