Issue Date: January 7, 2025
Issued by: Oncology Center of Excellence
Topic(s): Pediatric Product Development
Status: Draft
Considerations for Including Tissue Biopsies in Clinical Trials
This guidance provides recommendations to industry, investigators, institutions, and institutional review boards (IRBs) regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials that evaluate investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS). For the purposes of this guidance, a biopsy is a procedure that involves acquisition of tissue from a trial participant as part of a clinical trial protocol. Biopsies needed to inform routine clinical care are not included in this guidance.
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