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.
[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1066 Introduced in House (IH)]
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
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.
_______________________________________________________________________
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 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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Clinical Trials Modernization Act of
2015''.
SEC. 2. CLINICAL TRIAL MODERNIZATION.
(a) Proposals for Use of Innovative Statistical 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 following new section:
``SEC. 507. CLINICAL TRIAL MODERNIZATION.
``(a) In General.--To promote the efficiency of the development and
regulatory review and approval, licensure, or clearance of drugs,
biological products, and devices and the timely availability of
innovative treatments, the Secretary shall, after providing notice and
an opportunity 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 applications 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.--
(1) In general.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs (in
this subsection referred to as the ``Secretary''), shall--
(A) update and finalize the draft guidance
addressing the use of adaptive trial design for drugs
and biological products; and
(B) issue draft guidance on the use of Bayesian
methods in the development and regulatory review and
approval, licensure, or clearance of drugs, biological
products, and devices.
(2) Contents.--The guidances under paragraph (1) shall--
(A) establish or clarify standards for using
adaptive trial designs and Bayesian methods in clinical
trials, including clinical trials that form the primary
basis for approval, clearance, or licensure of the
products involved (such as trials that provide
substantial evidence for the approval of drugs);
(B) establish a mechanism for sponsors to obtain
feedback from the Secretary under section 507, as added
by subsection (a), on technical issues related to
modeling and simulations prior to--
(i) completion of such modeling or
simulations; or
(ii) the submission of resulting
information 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 enactment of this Act, with stakeholders
including representatives of regulated industry, academia,
patient advocacy organizations, and disease research
foundations.
(4) Schedule.--The Secretary shall, after providing notice
and opportunity for public comment, publish--
(A) the final guidance required by paragraph (1)(A)
not later than 6 months after the date of the public
meeting required by paragraph (3); and
(B) the guidance required by paragraph (1)(B) not
later than 12 months after the date of the public
meeting required by paragraph (3).
(5) Review and revision of guidance documents.--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 paragraph
(1) to reflect developments in statistical methods 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 products or devices;
or
(B) provide substantial evidence for the approval
of drugs.
SEC. 3. EVALUATIONS OF REQUIRED POSTAPPROVAL STUDIES 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 subparagraph:
``(G) Evaluations of required postapproval studies
and clinical trials.--
``(i) In general.--The Secretary shall
establish a process under which the 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 conducted 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 warranted.--In
the case of a determination under clause (i)(I)
that a postapproval study or clinical trial
required to be conducted 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 clinical
trial required to be conducted under this
paragraph should be renegotiated, the Secretary
shall enter into negotiations 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
subsection (a). Not later than two years after such date of enactment,
the Secretary shall issue final guidance on such implementation.
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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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