When are tissue biopsies really needed in clinical trials of medical products? Draft guidance from the US Food and Drug Administration (FDA) offers recommendations for weighing the risks and benefits of these potentially invasive procedures and ensuring informed consent from child and adult trial participants.
The guidance – titled Considerations for Including Tissue Biopsies in Clinical Trials Guidance for Industry, Investigators, Institutions, and IRBs – was developed by FDA in collaboration with the Department of Health and Human Services (HHS) Office for Health Research and Protections (OHRP) and applies to trials of medical products.
The draft guidance distinguishes between mandatory and optional biopsies. In the announcement, FDA and OHRP noted that a biopsy, defined as a “procedure that involves acquisition of tissue from a trial participant as part of a clinical trial protocol,” is sometimes essential for determining eligibility or evaluating treatment effects…
