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Abstract:
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There are 10,000 known diseases or conditions, but we only have cures and treatments for about 500 of them. The policies in the 21st Century Cures Act will help make drug and device development less time-consuming and less costly, which is good news for patients. The Act specifically calls out the broader application of Bayesian statistics and adaptive trial designs including issuing guidance document on the use of Bayesian methods in the development, regulatory review, and approval or licensure of drugs and biological products, as well as a process to facilitate technical discussions between regulators and sponsors related to modeling and simulations while an innovative design is being planned. It is important for statisticians across industry, regulatory, and academia to understand the impact of this legislation, collaborate to ensure open communication and appropriate application of methods, and ultimately fully capitalize on this groundbreaking legislation. We expect that this session will have a wide appeal due to the recency of this Act and urgent need to accelerate the pace of cures in the U.S.
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