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H.R. 1066

BillFederalHouseIn Committee
Clinical Trials Modernization Act of 2015
About This Bill
Committee
Latest Action · February 27, 2015
Referred to the Subcommittee on Health.
Congress
114th (2015–2017)
Introduced
February 25, 2015
Cosponsors (2)
0D 2R
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Summary

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Clinical Trials Modernization Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to allow sponsors of applications for new drugs, biological products, and medical devices to propose incorporation of alternative statistical methods, including adaptive trial design and Bayesian methods, into clinical trial protocols and marketing applications. The FDA is required to issue guidance that establishes or clarifies standards for using alternative statistical methods in clinical trials. The FDA must establish a process under which a post-approval study or clinical trial required by the FDA is periodically evaluated to determine whether the trial or study is no longer scientifically warranted or whether the design should be renegotiated because of changes in medical practice or the standard of care.

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