Andrew Moreno

DocwireNews

The FDA has issued a new draft guidance on inclusion within clinical trials of tissue biopsies collected from trial participants. Working with the US Department of Health and Human Services&rsquo; (HHS) Office for Human Research Protections, the FDA produced the draft toward an end of setting recommendations in this area. It announced this draft in a news release.The draft guidance is titled &ldquo;Considerations for Including Tissue Biopsies in Clinical Trials: Guidance for Industry, Investigators, Institutions, and IRBs.&rdquo; It was composed specifically by the FDA&rsquo;s Oncology Center of Excellence together with the 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Research, Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research.&ldquo;This new draft guidance builds on the agency&rsquo;s ongoing efforts to enhance clinical trials by providing recommendations to improve participant safety and further clinical research,&rdquo; remarked 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 new guidance is namely relevant to clinical trials of investigational medical products and trials conducted in association with the HHS. Its intended readership includes clinical investigators, researchers in industry, and institutional review boards.Questions the draft guidance engages include what biopsy information to include when obtaining informed consent from trial participants and whether biopsy collection should be required or optional. Both adult and pediatric participants of clinical trials are considered, and the draft addresses special issues such as weighing benefits and risks of collecting biopsy specimens from children.ReferenceFDA issues draft guidance on including tissue biopsies in clinical trials. FDA news release. <a href="https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-including-tissue-biopsies-clinical-trials">FDA. January 6, 2025</a>. Accessed January 9, 2025.

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FDA, HHS Generate Draft Guidance on Inclusion of Tissue Biopsies in Clinical Trials

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Questions surrounding informed consent, mandatory versus optional biopsy, and safety for adults and children are addressed.

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