Concepts must meet all of the below criteria to be approved for development:
- BTCRC studies can be Phase II or earlier. The BTCRC will not conduct industry-sponsored Phase III studies.
- Sponsor Investigator is from a BTCRC member institution.
- Studies should include a translational component that involves core or basic science lab.
- At a minimum, studies should include baseline whole blood for PBMC DNA/RNA, pre- and post-treatment serum and plasma. Archived FFPE tumor tissue will be collected and mandatory from all consenting subjects and will be available for future use by the BTCRC.
- The study involves mentorship of junior faculty by senior faculty.
- The study includes multi-disciplinary research and/or cross-collaboration between BTCRC institutions in the trial design whenever appropriate.
- BTCRC institutions will own the data from the study.
- The Sponsor Investigator has identified potential funders. (NOTE: It is preferable that concepts be brought to the BTCRC prior to budget discussions.)
- All subjects accrued should be from the BTCRC and non-academic sites which have entered into site agreements with BTCRC Administrative Headquarters or sub-contracts with BTCRC institutions. Non-BTCRC academic sites should not participate in BTCRC studies.