The U.S. Food and Drug Administration (FDA) issued a draft guidance in collaboration with the Office for Human Research Protections.
When finalized, the guidance will provide recommendations for including tissue biopsies as part of clinical trials. The draft guidance was designed to assist industry professionals, clinical investigators, institutions, and institutional review boards in understanding key considerations for the use of tissue biopsies in both adults and children. The guidance specifically focuses on clinical trials that evaluate investigational medical products and those conducted or supported by the U.S. Department of Health and Human Services (HHS).
The draft guidance focused on considerations for including a tissue biopsy in a clinical trial protocol, which involved taking tissue from a participant. While biopsies carried some inherent risks, they could be essential for obtaining critical information, such as determining participant eligibility, confirming the presence of the target medical condition being studied, or assessing primary and secondary trial endpoints.
The guidance outlined the decision-making process for classifying a tissue biopsy as either a required condition for participation or an optional procedure. It highlighted factors to consider when determining whether a biopsy should be mandatory or optional, both for adult and pediatric trial participants. Specifically, it addressed the unique risk and benefit considerations for biopsies in trials involving children. Furthermore, the draft guidance underscored the importance of obtaining informed consent from participants, which included parental or guardian permission for children, and, when appropriate, assent from the children themselves. It also provided recommendations on what should be included in the informed consent regarding biopsies.
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 added:
“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. This new draft guidance builds on the agency’s ongoing efforts to enhance clinical trials by providing recommendations to improve participant safety and further clinical research.”
