text: 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                      (A) update and finalize the draft guidance 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                      (B) issue draft guidance on the use of Bayesian 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.
target: 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.
feat_title: Clinical Trials Modernization Act of 2015