The U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that will offer suggestions for incorporating tissue biopsies into clinical trials once it is finalized. The draft guidance is intended, when finalized, to assist industry, clinical investigators, institutions, and institutional review boards in understanding considerations for tissue biopsies in adults and children as part of clinical trials that evaluate investigational medical products and/or that are conducted or supported by the U.S. Department of Health and Human Services (HHS).
This draft guidance focuses on factors to take into account when a clinical trial protocol includes a tissue biopsy, which is the removal of tissue from a trial participant. Although there is some risk associated with any biopsy procedure, biopsies may be required to gather data that is crucial to the trial, such as assessing primary or important secondary endpoints, determining clinical trial participant eligibility, or confirming that enrolled trial participants have the intended target medical condition the trial is evaluating.
In a clinical trial protocol, A tissue biopsy can be classified as either an optional biopsy that is not a requirement for participation in the trial or a mandatory biopsy that is. The draft guidance addresses factors to be considered when deciding whether a tissue biopsy should be mandatory or elective for adults and children taking part in clinical trials. The proposed guidelines also cover risk and benefit factors unique to tissue biopsies performed in pediatric clinical trials. Furthermore, the proposed guidance stresses the significance of getting participants' informed consent, including children's assent when appropriate and parental or guardian approval for minors. As part of informed consent, the draft guidance also suggests what details should be included concerning biopsies.
The draft guidance, “Considerations for Including Tissue Biopsies in Clinical Trials: Guidance for Industry, Investigators, Institutions, and IRBs,” was developed by the FDA’s Oncology Center of Excellence, 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, in collaboration with the HHS Office for Human Research Protections. Comments on the draft guidance must be submitted within 60 days after publication in the Federal Register to Regulations.gov to ensure the agency considers them.
Learn more: FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials | FDA