3.0.0 1066 2023-01-11T13:28:42Z 2023-01-11T13:28:42Z House HR 2015-02-25 114 [Congressional Record Volume 161, Number 32 (Wednesday, February 25, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. COLLINS of New York:H.R. 1066.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the United States Constitution.[Page H1164]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-02-27T15:03:19Z Referred to 2015-02-25T15:03:00Z 2015-02-27 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-02-25 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-02-25 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-02-25 Introduced in House IntroReferral 1000 9 Library of Congress C001092 Rep. Collins, Chris [R-NY-27] Chris Collins R NY 27 N P000602 Rep. Pompeo, Mike [R-KS-4] Mike Pompeo R KS 4 2015-02-25 True B001275 Rep. Bucshon, Larry [R-IN-8] Larry Bucshon R IN 8 2015-03-04 False Health Administrative law and regulatory procedures Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health technology, devices, supplies Medical research Health 00 2015-02-25 Introduced in House 2015-04-10T20:59:17Z 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.]]> Clinical Trials Modernization Act of 2015 Display Title Clinical Trials Modernization Act of 2015 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to promote the use of adaptive trial designs, Bayesian methods, and other innovative statistical methods in clinical protocols for drugs, biological products, and devices, and with respect to the requirement to conduct postapproval studies and clinical trials, and for other purposes. Introduced in House IH Short Titles as Introduced Clinical Trials Modernization Act of 2015 Introduced in House 2015-02-25T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr1066ih/xml/BILLS-114hr1066ih.xml 2015-02-27 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.