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GU Cancers 2026 | FDA draft guidance on novel clinical trial designs in oncology research

Pavlos Msaouel, MD, PhD, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses the relevance of a recent FDA’s draft guidance on novel clinical trial designs, which endorses innovative approaches to accelerate discoveries and utilize flexible designs and historical data. This guidance has the potential to benefit rare cancer types and enable more holistic extraction of information from data. This interview took place at the 2026 ASCO GU Cancers Symposium in San Francisco, CA.

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Transcript

Yeah, I think that this talk actually is now particularly pertinent given the FDA’s recent draft guidance on novel clinical trial designs, where the FDA has openly endorsed exciting new paradigms of how to think, conduct, and design clinical trials to accelerate discoveries, allow the use of more flexible designs, allow the utilization of historical data, focusing on also potential pathways for rare cancer types, and thinking a little bit more holistically about how to extract information from data in the best way possible...

Yeah, I think that this talk actually is now particularly pertinent given the FDA’s recent draft guidance on novel clinical trial designs, where the FDA has openly endorsed exciting new paradigms of how to think, conduct, and design clinical trials to accelerate discoveries, allow the use of more flexible designs, allow the utilization of historical data, focusing on also potential pathways for rare cancer types, and thinking a little bit more holistically about how to extract information from data in the best way possible.

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