Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA and OHRP just dropped draft guidance to help doctors, researchers, and review boards handle tissue biopsies in clinical trials safely and smartly. This affects anyone running or reviewing trials with biopsies, including kids and adults, and aims to make these studies clearer and better. You’ve got until March 10, 2025, to send in your thoughts before the final rules roll out—so get ready to weigh in!
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Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Optional Biopsies for Non-Key Uses
If you take part in a clinical trial (adult or child), the draft guidance says tissue biopsies done for non-key secondary endpoints, exploratory endpoints, or unspecified future research should not be required and instead should be optional.
Biopsies Required When Medically Necessary
The draft guidance states that when biopsied tissue is the only way to get information needed to answer key trial questions—such as determining eligibility or evaluating treatment effects—those biopsies may be required for trial participation.
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