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. These studies aim to assess the activity, feasibility or toxicity of new treatment approaches, and can be used to screen out inactive treatments.
Latest: Joint initiative for funding feasibility studies in primary brain tumours at the March 2010 CTAAC meeting
EXTENSION TO THE DEADLINE FOR APPLICATIONS.
Closing date: 18th December 2009
The Samantha Dickson Brain Tumour Trust and Cancer Research UK have launched a joint clinical trials initiative for funding feasibility studies in primary brain tumours. For more information please refer to the call for proposals document, which can be downloaded from the box on the right.
Please email Dr Rowena Sharpe for more details. Dr Sharpe can also be reached via phone on 020 7438 5394.
Research Areas
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.
- 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).
- 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).
Eligibility
The applicant must be from a UK university, clinical centre, or clinical trials unit.
Period of Funding
Funding is normally provided for up to 24 months.
Funding Value
Funding is usually at a level of approximately £25,000 per annum (up to a maximum of £40,000 in exceptional cases). 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. 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.
Submission deadlines
The deadlines for Feasibility Study Project Grants are on the same dates as for Phase III Clinical Trial Grants. These deadlines are as follows:
|
Submission Deadline |
Meeting In |
| Deadlines for Outline Applications, Feasibility Studies, Applications for CTAAC Approval
(i.e., endorsements - funding not required) and sample collection applications |
Friday 24th April 2009 |
July 2009 |
|
Friday 14th August 2009 |
November 2009 |
|
Friday 18th December 2009 |
March 2010 |
|
Friday 16th April 2010 |
July 2010 |
| Deadline for Full Applications (applications for funding already approved by CTAAC at outline stage) |
Friday 1st May 2009 |
July 2009 |
|
|
Friday 21st August 2009 |
November 2009 |
|
Monday 21st December 2009 |
March 2010 |
|
Friday 23rd April 2010 |
July 2010 |
Additional Information
Review Committee: Clinical Trials Awards and Advisory Committee (CTAAC)
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 1st 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.
Contact Details
For enquiries about this scheme, please contact:
Dr Rowena Sharpe
Tel: +44 (0) 20 7438 5394
Email: rowena.sharpe@cancer.org.uk
