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FDA Releases Draft Guidance for Clinical Trial Design


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The U.S. Food and Drug Administration (FDA) announced the availability of the Draft Guidance Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics.

Master protocol trial designs are complex due to the concurrent evaluation of multiple drugs and/or disease populations within a single trial, as well as their potential regulatory impact. It is important that the trials are well designed and well conducted to ensure patient safety and to obtain quality data that may support drug approval. This Draft Guidance provides advice to pharmaceutical sponsors, the academic community, institutional review boards, and the public on aspects of master protocol designs and trial conduct that pose additional regulatory consideration, such as biomarker development and statistical analysis considerations. The Draft Guidance also provides advice on the information that sponsors should submit to the FDA and how sponsors can interact with the FDA to facilitate efficient review.

For more details, refer to the Draft Guidance at FDA.gov ■


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