Drugs

Guide on Clinical Trials Using Tissue Biopsies

FDA has issued a draft guidance entitled “Considerations for Including Tissue Biopsies in Clinical Trials” that provides considerations for tissue biopsies in adults and children as part of clinical trials that evaluate investigational medical products. “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,” FDA Oncology Center of Excellence director Richard Pazdur is quoted in a release as saying. “This new draft guidance builds on the agency’s ongoing efforts to enhance clinical trials by providing recommendations to improve participant safety and further clinical research.”

The document focuses on considerations for when a tissue biopsy is included in a clinical trial protocol. “All biopsy procedures have a certain amount of risk, but biopsies can be necessary for obtaining information important to the trial, such as to determine clinical trial participant eligibility, to ensure enrolled trial participants have the intended target medical condition the trial is evaluating, or to evaluate primary or key secondary endpoints,” the agency says.

It says that a tissue biopsy may be described in a clinical trial protocol as a required biopsy that is a condition of trial participation, or an optional biopsy that is not a condition of participation. The draft guidance also addresses risk and benefit considerations specific to tissue biopsies conducted in clinical trials involving children. Additionally, it stresses the importance of obtaining informed consent from participants, and it provides recommendations for information to include about biopsies in the informed consent.

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