This Committee reviews and funds cancer clinical trial on behalf of Cancer Research UK. The main foci are phase III therapeutic and some large phase II trials. Please note: for small phase II trials and feasibility studies please view the Feasibility Study Project Grants web page.

CTAAC will initially review applications for 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 (see below). These may be submitted directly as a full proposal.

Assessment Criteria
The scope of CTAAC's responsibilities lie in two areas: to assess the scientific and technical merit of an application and to comment on other aspects of the application, which should be clearly separated from the assessment of the scientific merit.

Assessment criteria for CTAAC outline applications 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.

For full proposals the strengths of each application in all of these areas will be assessed by CTAAC and used to arrive at an overall score.

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.

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.

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.

Eligibility
Applicant must be from a UK university, clinical centre, or clinical trials unit.

Please note: Biological studies will not be funded by CTAAC unless they are being used to define treatment options. In all other cases, a separate application to the Translational Research in Clinical Trials Committee (TRICC) must be submitted

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

Extensions
Extensions can be applied for following consultation with the Committee Secretariat; 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.

Number offered
Varies. As a guide, 5 trials were endorsed and 30 trials were funded in 2005/2006 financial year.

How to apply
Please note Change to Application Process.

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

• All sections of the application must be completed before submission of the application.
  
  
• A covering letter must be submitted with all full applications.
  • Full applications - addressing each of the Committee's concerns point by point at outline stage or revised application stage.
  • Endorsements - highlighting key points and objectives.
  • Extensions - fully justifying reasons for extension request.
  
  In the absence of a covering letter the application will not be considered by the Committee.
• Please Note:
  CTAAC no longer requires trial protocols to be submitted with full applications (with the exception of International Trials, i.e., 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 where applicable or as extra appendices:

  1. Details on statistical analysis and interim analysis
  2. Methodological details
  3. Flow diagrams
  4. Treatment regimens (e.g. radiotherapy)
  5. Surgical procedures and plans for Quality Control
  6. Standard Operating Procedures.

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

  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%
• Applicants are strongly advised to liaise with the relevant NCRI Clinical Study Group (CSG) whilst compiling their application.
  
  
• Applicants are strongly advised to contact an NCRI accredited Clinical Trials Unit (CTU) for advice and guidance whilst compiling their application.
  
  
• Previously declined applications:
  • Please note: The decision of the Committee is final and we are unable to accept revised applications to Cancer Research UK, unless the Committee has specifically recommended this.

    We would welcome any new applications that you might wish to make providing the content is different from the original application or if new data (relevant to the proposal) has been provided. Before submitting such an application, or if you require any further clarification, please contact the Committee Secretariat.

Closing date
CTAAC meets three times per year and considers both outline and full applications at each meeting. It also considers proposals for Fesability Project Grants.

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:

For further information please contact Nicola Keat (Clinical and Translational Research Directorate) at nicola.keat@cancer.org.uk.