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Pharmaceuticals / Regulatory Affairs

FDA Issues Guidances on Clinical Trial Enrichment, Monitoring

March 21, 2019
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The FDA released two clinical-related guidances for sponsors of drugs and biologics, on enrichment of clinical trials and on risk-based monitoring.

Commissioner Scott Gottlieb referred to enrichment as “a key strategy in the development of precision medicine,” relying on the selection of patients for trials based on one or more characteristics, to demonstrate the safety and/or the effectiveness of the drug or biologic in selected populations.

Sponsors might consider choosing patients with a biomarker characterizing their disease in a narrow range, or identifying high-risk or more responsive patients, the agency said, in a final guidance on enrichment strategies for effectiveness trials.

“The same information used to select patients based on their likelihood of responding positively to a drug in a trial can be used to guide real-world care,” Gottlieb said. He tied the two guidances into the FDA’s broader work to streamline and modernize clinical trials.

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