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HR 1066 114th Congress House

Clinical Trials Modernization Act of 2015

Official title: 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 c… Show full official titleShow less

Official title: 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: February 25, 2015 See on congress.gov
Health Administrative law and regulatory proceduresAdministrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulation
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Food and Drug Administration (FDA)Health technology, devices, suppliesMedical research
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This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 27, 2015
Referred to the Subcommittee on Health.
Feb 25, 2015
Referred to the House Committee on Energy and Commerce.
Feb 25, 2015
Introduced in House
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 Latest action February 27, 2015

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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.
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 1066: Clinical Trials Modernization Act of 2015. 114th Congress. Open America. https://openamerica.io/bill/114-HR-1066/
MLA
"H.R. 1066: Clinical Trials Modernization Act of 2015." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-1066/.
Bluebook (legal)
H.R. 1066, 114th Cong. (2026), https://openamerica.io/bill/114-HR-1066/.
Markdown link
[H.R. 1066: Clinical Trials Modernization Act of 2015](https://openamerica.io/bill/114-HR-1066/)
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