Phase III Clinical Trials Grants

Cancer Research UK welcomes studies for cancer treatment directed at the tumour such as chemotherapy, radiotherapy and surgery with the principle objective of improving survival.

Research Areas

The Phase III Clinical Trials Grants scheme is run through the Clinical Trials Awards and Advisory Committee (CTAAC) which reviews and funds cancer clinical trials.

CTAAC accepts investigator-led studies, except first-in-man studies, including:

1. Phase III/IV therapeutic trials
2. Large scale Phase II trials that are over 2 years in duration and, or greater than £40,000 per annum.

CTAAC will initially review applications for phase III and large phase II cancer trials as outline proposals. The exception to this will be finalised protocols of international studies and protocols submitted for peer review and endorsement by the Committee. These may be submitted directly as a full proposal.

Late phase clinical trial applications submitted to CTAAC are assessed based on their scientific and technical merit. Assessment criteria are as follows:

• Clinical importance of the research question;
• Scientific importance of the research question;
• Adequacy of background and preliminary data;
• Strength of study design, including statistical design;
• Expected interest/appeal to patients and likelihood of adequate accrual;
• Anticipated opening for trial in portfolio.

Please note,
for small phase II trials and feasibility studies please view the information on Feasibility Study Project Grants.

Eligibility

The applicant must be from a UK university, clinical centre, or clinical trials unit.

Please note,
the decision of the Committee is final and Cancer Research UK is unable to accept revised applications to Cancer Research UK, unless the Committee has specifically recommended this. We welcome new applications, provided that the content is different from the original application, or if new data (relevant to the proposal) has been collected. Before submitting an application with new data, or if you require any clarification, please contact Nicola Keat.

Period of Funding

Funding is provided for trials that are up to 10 years in duration.

Funding Value

Funding is usually at a level of approximately £100,000 per annum, unless there are exceptional circumstances. Individuals submitting applications above the level of £100,000 per annum are advised to contact Nicola Keat to discuss this.

Funding decisions are made on the basis of scientific merit.

How to apply

This scheme has a two part process and both the Application Form and Guidelines can be downloaded from the Resources box on the right.

All sections of the application must be completed before submission of the application.

A cover letter must be submitted with all full applications - the Committee will not consider the application without this. Depending on the type of application that you are applying for, you must provide the following information in you cover letter:

• For full applications
  The letter should address all of the Committee's concerns which were raised at the outline stage or revised application stage.
• For endorsements
  Information should cover objectives and highlight key points.
• For extensions
  A full justification for the extension request should be included within the letter.

Please Note:
CTAAC no longer requires trial protocols to be submitted with full applications (with the exception of International Trials, including, EORTC Trials, and Extension Applications). As a result you must ensure that the following information has been provided under the appropriate headings within the application form or as extra appendices:

• Details on statistical analysis and interim analysis
• Methodological details
• Flow diagrams
• Treatment regimens (e.g. radiotherapy)
• Surgical procedures and plans for Quality Control
• Standard Operating Procedures.

A draft Patient Information Sheet and Consent Form must also be submitted.

Applicants are strongly advised to contact the relevant NCRI Clinical Study Group (CSG) whilst completing your application. For additional advice and guidance, applicants are advised to contact a NCRI accredited Clinical Trials Unit (CTU) or a UKCRC registered CTU, whilst compiling their application.

Submission deadlines

Following consideration of outline proposals, successful applicants submitting a full proposal to CTAAC will be invited to do so for the next meeting. In order to meet the deadline for the following meeting (approximately six weeks following feedback) applicants are advised to have considered the requirements for a full application in advance.

Forthcoming deadlines for applications are as follows:

Additional Information

Review Committee: Clinical Trials Awards and Advisory Committee (CTAAC)

All studies supported through CTAAC are automatically eligible for National Institute for Heath Research (NIHR) support and are listed on the UKCRN database of trials.

Please note: for proposals that incorporate separate (although integrated) trials for sub-sets of patient populations you must submit clear and separate outline proposals for each component of the study including trial design and statistics, in order to allow each trial to be reviewed as stand-alone proposals.

The Committee recognises the advantages of submitting a single full proposal both in terms of cost effectiveness to the Charity but also in negotiating the necessary legislative requirements.

Therefore, if you are successful at the outline stage the Committee will provide clear guidance on which components of the trials should be incorporated within a single full proposal.

National Institute for Health Research (NIHR) funding dictates that all trials are subject to national, competitive peer review, therefore the Committee must be given the opportunity to review and question (and if appropriate) reject separate components. This type of outline proposal should be submitted with a cover letter, which includes justification for integrating the various components of the study, including that of cost effectiveness.

Resubmissions

Extension applications will also be considered by CTAAC and studies in receipt of educational grants from the pharmaceutical industry can be submitted for endorsement.

Extensions can be applied for following consultation with Nicola Keat: you must contact the office 6-8 months in advance of funding completion. All extension applications must be submitted on an extension application form. All extensions require a covering letter fully justifying the reasons for an extension request.

In the instance that a trial is approved by CTAAC and major amendments are made to the trial protocol post-Committee decision, the application must be re-reviewed by the Committee.

Criteria necessitating a re-submission in case of changes to the trial design post-CTAAC approval include:

• Dropping or adding a treatment arm
• Changing or adding drugs within existing arms
• Changing main trial endpoint
• Modifying the sample size by >10%

Contact Details

For enquiries relating to this scheme, please contact:

Nicola Keat
Tel: +44 (0) 20 7438 5392
Email: nicola.keat@cancer.org.uk