FDA, HHS Work on Recommendations Regarding Inclusion of Tissue Biopsies in Clinical Trials

The FDA has issued a new draft guidance with the goal of ultimately producing recommendations regarding inclusion within clinical trials of tissue biopsies collected from trial participants. The FDA announced this new guidance in a news release.

Working in conjunction with the US Department of Health and Human Services’ (HHS) Office for Human Research Protections, 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 composed the guidance. It is titled “Considerations for Including Tissue Biopsies in Clinical Trials: Guidance for Industry, Investigators, Institutions, and IRBs.”

“This new draft guidance builds on the agency’s ongoing efforts to enhance clinical trials by providing recommendations to improve participant safety and further clinical research,” commented Richard Pazdur, MD, director of the Oncology Center of Excellence and acting director of the Office of Oncologic Diseases at the Center for Drug Evaluation and Research.

The guidance is directed toward an audience of clinical investigators, institutional review boards, and researchers in industry. It pertains to clinical trials evaluating investigational medical products or trials conducted in association with the HHS.

Issues encompassed by the new guidance include whether biopsies should be mandatory or optional and the information to include when obtaining informed consent from trial participants. It addresses considerations for both adult and pediatric trials, especially risks and benefits related to collecting biopsy specimens from children.

Reference

FDA issues draft guidance on including tissue biopsies in clinical trials. FDA news release. FDA. January 6, 2025. Accessed January 9, 2025.