US FDA Proposes Tissue Biopsies in Clinical Trials

The US Food and Drug Administration (FDA) released a draft guidance in collaboration with the Office for Human Research Protections that, once finalized, will offer suggestions for incorporating tissue biopsies into clinical trials. The draft guidance aims to help industry, clinical researchers, institutions, and institutional review boards comprehend the considerations for tissue biopsies in both adults and children involved in clinical trials assessing investigational medical products and/or those funded or conducted by the US Department of Health and Human Services (HHS) when it is finalized.

“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,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s 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 “This new draft guidance builds on the agency’s ongoing efforts to enhance clinical trials by providing recommendations to improve participant safety and further clinical research.”

This draft guidance emphasizes the factors to consider when a tissue biopsy, which entails obtaining tissue from a trial participant, is part of a clinical trial protocol. Every biopsy procedure carries some level of risk; however, biopsies can be essential for acquiring crucial information for the trial. This includes assessing participant eligibility, confirming that enrolled participants have the specific medical condition the trial is investigating, or evaluating primary or significant secondary endpoints.