Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Laboratory Values”

Public Comments

Comments provided on: June 24, 2024

Comments provided to: U.S. Food and Drug Administration

Summary: We stated in our public comment submission that the MRCT Center agrees with the FDA that overly restrictive laboratory value-based eligibility criteria are problematic and that such criteria may well exclude the very cancer patients that may benefit from the treatment under study, particularly when the malignancy (or its prior treatment) is affecting those lab values. The MRCT Center also asked for more specific examples of how to describe the potential variation of lab values (e.g., by race) and any additional/confirmatory testing needed in the eligibility criteria so as to better support a position of inclusion-by-default and exclusion-only-when-necessary.