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Today, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials.
The draft guidance is intended, when finalized, to assist industry, clinical investigators, institutions, and institutional review boards in understanding considerations for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).
The draft guidance, “Considerations for Including Tissue Biopsies in Clinical Trials: Guidance for Industry, Investigators, Institutions, and IRBs,” was developed by the FDA’s Oncology Center of Excellence, Office of the Chief Medical Officer, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research, in collaboration with the HHS Office for Human Research Protections. Comments on the draft guidance must be submitted within 60 days after publication in the Federal Register to Regulations.gov to ensure the agency considers them.
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