Category 1. Prospective sample collection and biomarker research using samples from a clinical trial that is about to commence or is ongoing.

1. Subject to successful review by international referees and TRICC, support for the sample collection would be agreed upon upfront.
2. Funding for the biomarker research may also be agreed up-front, but the committee reserves the right to defer this funding subject to evidence of satisfactory sample collection.

Category 2. Retrospective sample collection and biomarker research, i.e., collection and biomarker research using samples from clinical trials closed to recruitment.

Category 3. Prospective sample collection of samples alone from a clinical trial that is about to commence or is ongoing. Support will be provided for the collection of tumour blocks and bloods only, unless specific justification can be made by an applicant for the collection of additional sample types.

Category 4. Exploratory biomarker research using samples outside of a clinical trial to define the distribution of biomarker results in the target patient population and the feasibility of applying the assay to "routine" clinical samples (category 1 and 2 grants). The expectation is that a category 1 or 2 application to TRICC will follow the exploratory biomarkers study.

TRICC operates a two step application process for category 1, 2 and 4 applications, reviewing proposals as outline applications, before deciding whether a full proposal should be invited at a subsequent meeting. Detailed feedback is provided at this stage to assist in refining and improving the final (full) proposal and increase the chances of funding.

Category 3 applications for prospective sample collections alone should be submitted directly as a full application. As for category 1 funding, the trial must be approved before a full sample collection application is submitted.

For category 4:
For category 4 grants the patient population used should represent/match that to be studied when using this biomarker in a subsequent Clinical trial.

In reviewing applications Cancer Research UK expects the following:

1. For all applications:
   • that the collection, processing and handling of biological samples conforms with prevailing regulatory standards
   • that SOPs are provided for collection, processing and storage of samples
   • evidence that samples are `fit for purpose'
2. For category 1, 2 and 4 applications:
   • that the proposed assays are well validated and appropriate quality assurance mechanisms are in place
   • that pilot data using the validated assays are provided; generated with samples of the type that have been/will be collected
3. For category 1 and 2 applications:
   • that there is a clear biological hypothesis which is best tested within the context of the clinical trial, and for which the translational data will be linked to the clinical outcome data
   • that the design of the clinical trial is such that it takes account of the importance of the biological question, and that sample sizes are adequate to answer the biological hypothesis
   • that there is evidence of clear collaboration between the clinical and scientific collaborators
   • that the issue of recording biological data, linking to the clinical trial database and subsequent analysis has been considered and resolved before the trial starts

For sample collections alone, the potential utility of a collection associated with a new trial will be assessed by the Committee; the principles for access to the samples by other researchers in the future should be in place from the outset.

Place of tenure
Applicant must be from a UK university, clinical centre, or clinical trials unit.

Value
Applications should not exceed £100,000 per annum, £500,000 in total for a five year study.

Closing date
The table below provides the deadlines for the different types of application

Note: Applicants should ensure that patient consent, ethical issues and governance requirements regarding the use of retrospective or prospective samples are fully addressed.

Potential applicants who are unsure of the suitability of their proposal for TRICC project grant funding should contact Dr Maria Lioumi, Research Manager (Translational Research).

For sample collection only queries please contact Dr Tasneem Ahmed.