I 
114TH CONGRESS 
1ST SESSION H. R. 1066 
To amend the Federal Food, Drug, and Cosmetic Act to promote the use 
of adaptive trial designs, Bayesian methods, and other innovative statis-
tical 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. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 25, 2015 
Mr. COLLINS of New York (for himself and Mr. POMPEO) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
promote the use of adaptive trial designs, Bayesian meth-
ods, 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Clinical Trials Mod-
ernization Act of 2015’’. 
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SEC. 2. CLINICAL TRIAL MODERNIZATION. 
(a) PROPOSALS FOR USE OF INNOVATIVE STATIS-
TICAL METHODS IN CLINICAL PROTOCOLS FOR DRUGS, 
BIOLOGICAL PRODUCTS, AND DEVICES.—Chapter V of 
the Federal Food, Drug, and Cosmetic Act is amended 
by inserting after section 506F (21 U.S.C. 356f) the fol-
lowing new section: 
‘‘SEC. 507. CLINICAL TRIAL MODERNIZATION. 
‘‘(a) IN GENERAL.—To promote the efficiency of the 
development and regulatory review and approval, licen-
sure, or clearance of drugs, biological products, and de-
vices and the timely availability of innovative treatments, 
the Secretary shall, after providing notice and an oppor-
tunity for public comment, establish and implement a 
framework through which— 
‘‘(1) sponsors of drugs, biological products, or 
devices may submit to the Secretary a proposal for 
the incorporation of adaptive trial designs, Bayesian 
methods, or other alternative statistical methods into 
proposed clinical protocols and marketing applica-
tions for drugs, biological products, or devices; and 
‘‘(2) the Secretary will commit to timelines for 
reviewing and providing feedback on proposals so 
submitted.’’. 
(b) GUIDANCE ADDRESSING USE
OF ADAPTIVE 
TRIAL DESIGNS AND BAYESIAN METHODS.— 
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(i) completion of such modeling or 
simulations; or 
(ii) the submission of resulting infor-
mation to the Secretary; 
(C) specify the types of quantitative and 
qualitative information required for review; and 
(D) specify the recommended analysis 
methodology. 
(3) PUBLIC
MEETING.—Prior to updating or 
developing the guidances required by paragraph (1), 
the Secretary shall consult, through a public meeting 
to be held no later than 1 year after the date of en-
actment of this Act, with stakeholders including rep-
resentatives of regulated industry, academia, patient 
advocacy organizations, and disease research founda-
tions. 
(4) SCHEDULE.—The Secretary shall, after pro-
viding notice and opportunity for public comment, 
publish— 
(A) the final guidance required by para-
graph (1)(A) not later than 6 months after the 
date of the public meeting required by para-
graph (3); and 
(B) the guidance required by paragraph 
(1)(B) not later than 12 months after the date 
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of the public meeting required by paragraph 
(3). 
(5) REVIEW AND REVISION OF GUIDANCE DOC-
UMENTS.—Not later than 48 months after the date 
of enactment of this Act, the Secretary shall review 
and, as appropriate, revise the guidance documents 
required by subparagraphs (A) and (B) of para-
graph (1) to reflect developments in statistical meth-
ods that could be appropriate for use in clinical 
trials, including clinical trials that— 
(A) form the primary basis for approval, 
clearance, or licensure of drugs, biological prod-
ucts or devices; or 
(B) provide substantial evidence for the 
approval of drugs. 
SEC. 3. EVALUATIONS OF REQUIRED POSTAPPROVAL STUD-
IES AND CLINICAL TRIALS. 
(a) IN GENERAL.—Section 505(o)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)) is 
amended by adding at the end the following new subpara-
graph: 
‘‘(G) EVALUATIONS
OF
REQUIRED
POST-
APPROVAL STUDIES AND CLINICAL TRIALS.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall establish a process under which the 
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Secretary, on the initiative of the Secretary 
or at the request of a responsible person, 
shall periodically evaluate a postapproval 
study or clinical trial required to be con-
ducted under this paragraph to determine 
whether— 
‘‘(I) the trial or study is no 
longer scientifically warranted; or 
‘‘(II) the design, or the timelines 
applicable to the completion of, the 
study or trial should be renegotiated 
because of changes in medical practice 
or the standard of care. 
‘‘(ii) 
NOT
SCIENTIFICALLY
WAR-
RANTED.—In the case of a determination 
under clause (i)(I) that a postapproval 
study or clinical trial required to be con-
ducted under this paragraph is no longer 
scientifically warranted, the Secretary shall 
no longer require the responsible person to 
conduct the study or trial. 
‘‘(iii) RENEGOTIATION.—In the case 
of a determination under clause (i)(II) that 
the design, or the timelines applicable to 
the completion of, a postapproval study or 
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clinical trial required to be conducted 
under this paragraph should be renegoti-
ated, the Secretary shall enter into nego-
tiations with the responsible person to 
make such changes as may be necessary to 
such design or timelines as the Secretary 
determines are necessary.’’. 
(b) GUIDANCE.—Not later than one year after the 
date of the enactment of this Act, the Secretary shall issue 
draft guidance on the implementation of subparagraph 
(G) of section 505(o)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(o)(3)), as added by sub-
section (a). Not later than two years after such date of 
enactment, the Secretary shall issue final guidance on 
such implementation. 
Æ 
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