Cancer Research UK (CR-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 1st May 2004.

CR-UK has therefore developed this new 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 (see How to Apply below).

These studies should be viewed as purpose-driven preparatory work for phase III trials, to assess the activity, feasibility or toxicity of new treatment approaches, and be used to screen out inactive treatments.

Projects are available in the order of £25,000 per annum (up to a maximum of £40,000 in exceptional cases) for a period of up to 24 months. Academically-led studies receiving educational grants and/or free drugs can be submitted for approval.

If you are unsure whether this scheme is suitable for you, please contact Dr Rowena Sharpe.

Feasibility Study Project Grant Eligibility
The types of study eligible for funding are as follows:

1. 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.
2. Single or multi-centre pilot studies involving a significant translational component, e.g. validation of a target that would be used to determine a therapeutic intervention (such as changing levels of CA125).
3. Trials receiving educational grants and/or free drug can be submitted for approval (industry-sponsored trials cannot be reviewed under this scheme).

The Application form and Guidelines for application can be downloaded from the Resources box on the right.

All sections of the application form must be completed before submission. Applicants are strongly advised to liaise with a clinical trials unit in writing their application. You 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.

Closing dates for Applications

Please see the Phase III Clinical Trial Grants web page for deadlines.

For further information please contact Dr Rowena Sharpe (Clinical and Translational Research Directorate) at rowena.sharpe@cancer.org.uk.