The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance titled “Considerations for Including Tissue Biopsies in Clinical Trials.” This document offers advice on implementing tissue biopsies in clinical trials, whether conducted on adults or children, especially when evaluating investigational medical products supported by the Department of Health and Human Services (HHS). It emphasizes that while biopsies can pose risks, they can be vital for certain trial evaluations, and often, participation in such biopsies should be optional if they serve exploratory or non-essential purposes. The guidance is open for public comment until March 10, 2025.
Simple Explanation
The FDA has made a guide about using small pieces of tissue from the body, called biopsies, in special tests to make sure new medicines and treatments are safe. They say it's important to be careful because these tests can sometimes be risky, and they welcome people's thoughts about this until March 10, 2025.