WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently released a draft guidance in collaboration with the Office for Human Research Protections, outlining recommendations for including tissue biopsies in clinical trials. When finalized, this guidance aims to assist industry stakeholders, clinical investigators, institutions, and institutional review boards in understanding the role and ethical considerations of incorporating biopsies into clinical research protocols.
According to the FDA, tissue biopsies are often vital in clinical trials to determine participant eligibility or to evaluate the effects of investigational medical products. However, as these procedures carry inherent risks, the draft guidance underscores the importance of improving participant safety and ensuring informed consent. The document offers recommendations for balancing the potential risks and benefits of biopsies, with specific considerations for both adult and pediatric participants.
“Tissue biopsies in clinical trials are often needed to determine eligibility or to understand the effect of the medical product being studied in the trial,” stated Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research. “This new draft guidance builds on the agency’s ongoing efforts to enhance clinical trials by providing recommendations to improve participant safety and further clinical research.”
The guidance differentiates between required biopsies, which are conditions of trial participation, and optional biopsies, which are not mandatory for participation. It emphasizes risk mitigation efforts for involving children in such procedures, including the necessity of parental or guardian permission and, when appropriate, child assent. The draft also advocates for clear information about biopsies to be included in participant consent forms to ensure full transparency.
This initiative is a collaborative effort from several FDA offices, including the Oncology Center of Excellence and the Office of the Chief Medical Officer, as well as other FDA centers that oversee drugs, devices, and biologics. Comments on the draft guidance, titled “Considerations for Including Tissue Biopsies in Clinical Trials,” can be submitted to Regulations.gov by March 10, 2025, to help shape the finalized document.
The FDA’s draft guidance aims to address the use of tissue biopsies in clinical trials, which are essential for understanding the safety and efficacy of new therapies.
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