A concept must meet all the criteria below for a Clinical Trial Working Group to approve it for development as a Big Ten CRC study:

  • Big Ten CRC studies must be Phase II or earlier investigator-initiated studies. The Big Ten CRC will not conduct Phase III industry-sponsored studies.
  • A Big Ten CRC member institution employs the sponsor-investigator leading the study.
  • Studies must include a translational component.
  • At a minimum, studies will include baseline whole blood for PBMC, DNA/RNA, pre- and post-treatment serum and plasma for future use.
  • The study involves mentorship of junior faculty by senior faculty.
  • The study involves multi-disciplinary research and/or cross collaboration among Big Ten CRC institutions in the trial design whenever appropriate.
  • The sponsor-investigator has identified potential funders.

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