Feasibility Study Project Grants
Feasibility studies, pilot studies and Phase II trials are viewed as purpose-driven preparatory studies, essential for determining the most appropriate questions for the next generation of Phase III trials. The Feasibility Study Project Grants scheme funds studies testing aspects of feasibility or tolerability and/or efficacy.
What is covered
Cancer Research UK accepts investigator-led studies, except first in man studies, including:
- Single or multi-centre prospective therapeutic (IMP and non-IMP), diagnostic or prevention phase II studies testing aspects of feasibility, tolerability and/or efficacy. Trials may involve more than one NCRN network, or several centres within a network.
- Academically-led feasibility studies in receipt of educational grants or free drugs from the pharmaceutical industry can be submitted for endorsement (industry-sponsored trials cannot be reviewed under this scheme).
The applicant must be from a UK university, clinical centre or clinical trials unit.
Applicants planning to submit an application for funding or endorsement of an early phase trial are encouraged to refer to the Clinical Trial Funding Scheme Guide (PDF 19KB). Please complete the New Trial Summary Proforma (MS Word 111KB) and email it to Andrea McConnell (contact details below) if it contains Phase I elements. The Office will work with you to advise on whether to apply to the New Agents Committee (which reviews phase I and 'First-in-Man' studies), or for a Feasibility Study Project Grant.
Period of funding
The maximum allowable duration is 48 months (studies are typically 24 months in duration).
Funding is usually at a level of approximately £25,000 per annum. The upper limit of funding for the entire duration of an award is £80,000. Funding decisions are made on the basis of scientific merit.
How to apply
Cancer Research UK developed this funding scheme in response to the need of the clinical trials community to receive dedicated funding to conduct feasibility, pilot or phase II studies that meet the requirements of new governance standards, and which will identify the most appropriate phase III trials - it is a one-stage application process.
Applications should be submitted via our online grants management system, eGMS (find out more about eGMS). Applications are only fully submitted to Cancer Research UK once approved by your host institution administrators. Please note that applications submitted by post or email will no longer be accepted. Guidelines on completing an application can be downloaded from the box on the right hand side of this page.
|Preliminary submissions||Final submissions||Committee review|
|N/A||1 Aug 2013||Nov 2013|
|N/A||21 Nov 2013||Mar 2014|
Applicants are strongly advised to contact an NCRI accredited Clinical Trials Unit (CTU) or a UKCRC Registered CTU for advice and guidance whilst compiling their application. Applicants may also wish to refer to the following textbook in choosing the appropriate trial design:
'Clinical trials in cancer' by Girling D, Parmar M, Stenning S, Stephens R and Stewart L, Oxford University Press, Oxford 2003 (ISBN 0-19-262959-X).
The use of a randomised phase II trial design, for example, can be particularly useful when good data on response to standard therapy are lacking, for reasons such as the disease is rare, there is limited knowledge of prognostic factors and their potential impact on outcome, or where several potential new therapies require testing. In the latter case, the intention is to eliminate inactive treatments, not compare arms. A true randomised phase II trial is not primarily intended to be comparative.
Cancer Research UK recognised that, largely as a result of the demands of the EU Clinical Trials Directive (EUCTD), there was a growing problem in running purpose-driven preparatory studies for academically-lead phase III trials in cancer.
As a result, the views of the NCRI Clinical Studies Groups members, the Directors of NCRI Accredited Clinical Trials Units and all NCRN Clinical Leads were canvassed on whether there was sufficient activity and interest in conducting feasibility studies, and consequently the level of resource that might be required. 100% of respondents actively involved in this type of study reported that running them had become more difficult and more expensive since the introduction of the EUCTD on 1 May 2004.
Cancer Research UK therefore developed this funding scheme in response to the need of the clinical trials community to receive dedicated funding to conduct feasibility, pilot or phase II studies that meet the requirements of new governance standards, and which will identify the most appropriate phase III trials - it is a one-stage application process.