Draft Guidance on Conditions for Including Tissue Biopsies in Clinical Trials

On January 7, 2025, the Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration issued a draft guidance with that, when finalized, will provide recommendations about including tissue biopsies as part of clinical trials, and provide considerations for determining if a tissue biopsy should be required or optional.  The draft guidance is intended, when finalized, to assist industry, clinical investigators, institutions, and institutional review boards in understanding considerations for tissue biopsies in adults and children as part of clinical trials that evaluate investigational medical products and/or that are conducted or supported by the U.S. Department of Health and Human Services (HHS).

Comments about the draft guidance, “Considerations for Including Tissue Biopsies in Clinical Trials: Guidance for Industry, Investigators, Institutions, and IRBs,” can be submitted through March 10, 2025, by following instructions in the Federal Register (90 FR 1173), which can be accessed here: https://www.federalregister.gov/documents/2025/01/07/2024-31536/considerations-for-including-tissue-biopsies-in-clinical-trials-draft-guidance-for-industry

The text of the draft guidance document appears on OHRP’s website (https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-considerations-including-tissue-biopsies-clinical-trials/index.html) and is also available on FDA’s website.