Sec. 502. Modernizing clinical trials
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Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall issue or revise draft guidance regarding the appropriate use of validated digital health technologies in clinical trials to help improve recruitment for, retention in, participation in, and data collection during, clinical trials, and provide for novel clinical trial designs utilizing such technology for purposes of supporting the development of, and review of applications for, drugs and devices.
Not later than 18 months after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance. The guidance described in paragraph
(1)shall include— recommendations for data collection methodologies by which sponsors may incorporate the use of digital health technologies in clinical trials to collect data remotely from trial participants; considerations for privacy and security protections for data collected during a clinical trial, including— recommendations for the protection of trial participant data that is collected or used in research, using digital health technologies; compliance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), subpart B of part 50 of title 21, Code of Federal Regulations, subpart C of part 56 of title 21, Code of Federal Regulations, the Federal policy for the protection of human subjects under subpart A of part 46 of title 45, Code of Federal Regulations (commonly known as the Common Rule ), and part 2 of title 42, Code of Federal Regulations (or any successor regulations); and recommendations for protection of clinical trial participant data against cybersecurity threats, as applicable; considerations on data collection methods to help increase recruitment of clinical trial participants and the level of participation of such participants, reduce burden on clinical trial participants, and optimize data quality; recommendations for the use of electronic methods to obtain informed consent from clinical trial participants, taking into consideration applicable Federal law, including subpart B of part 50 of title 21, Code of Federal Regulations (or successor regulations), and, as appropriate, State law; best practices for communication and early engagement between sponsors and the Secretary on the development of data collection methods; the appropriate format to submit such data to the Secretary; a description of the manner in which the Secretary may assess or evaluate data collected through digital health technologies to support the development of the drug or device; recommendations regarding the data and information needed to demonstrate that a digital health technology is fit-for-purpose for a clinical trial, and a description of how the Secretary will evaluate such data and information; and recommendations for increasing access to, and the use of, digital health technologies in clinical trials to facilitate the inclusion of diverse and underrepresented populations, as appropriate, including considerations for access to, and the use of, digital health technologies in clinical trials by people with disabilities and pediatric populations. Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance to provide recommendations to clarify and advance the use of decentralized clinical trials to support the development of drugs and devices and help improve trial participant engagement and advance the use of flexible and novel clinical trial designs. Not later than 18 months after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance. The guidance described in paragraph
(1)shall include— recommendations for methods of remote data collection, including trial participant experience data, though the use of digital health technologies, telemedicine, local laboratories, local health care providers, or other options for data collection; considerations for sponsors to minimize or reduce burdens for clinical trial participants associated with participating in a clinical trial, such as the use of digital technologies, telemedicine, local laboratories, local health care providers, or other data collection or assessment options, health care provider home visits, direct-to-participant shipping of investigational drugs and devices, and electronic informed consent, as appropriate; recommendations regarding conducting decentralized clinical trials to facilitate and encourage diversity among the clinical trial participants, as appropriate; recommendations for strategies and methods for recruiting, retaining, and engaging with clinical trial participants, including communication regarding the role of trial participants and community partners to facilitate clinical trial recruitment and engagement, including with respect to diverse and underrepresented populations, as appropriate; considerations for review and oversight by sponsors and institutional review boards, including remote trial oversight; recommendations for decentralized clinical trial protocol designs and processes for evaluating such proposed trial designs; recommendations for digital health technology and other remote assessment tools that may support decentralized clinical trials, including guidance on appropriate technological platforms and tools, data collection and use, data integrity, and communication to clinical trial participants through such technology; a description of the manner in which the Secretary will assess or evaluate data collected within a decentralized clinical trial to support the development of the drug or device, if the manner is different from that used for a non-decentralized trial; considerations for sponsors to validate digital technologies and establish appropriate clinical endpoints for use in decentralized trials; considerations for privacy and security of personally identifiable information of trial participants; and considerations for conducting clinical trials using centralized approaches in conjunction with decentralized approaches. Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance on the use of seamless, concurrent, and other innovative clinical trial designs to support the expedited development and review of applications for drugs, as appropriate. Not later than 18 months after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance. The guidance described in paragraph
(1)shall include— recommendations on the use of expansion cohorts and other seamless clinical trial designs to assess different aspects of product candidates in one continuous trial, including how such clinical trial designs can be used as part of meeting the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(d) ); recommendations on the use of clinical trial designs that involve the concurrent conduct of different or multiple clinical trial phases, and the concurrent conduct of preclinical testing, to expedite the development of new drugs and facilitate the timely collection of data; recommendations for how to streamline trial logistics and facilitate the efficient collection and analysis of clinical trial data, including any planned interim analyses and how such analyses could be used to streamline the product development and review processes; considerations to assist sponsors in ensuring the rights, safety, and welfare of clinical trial participants, maintaining compliance with good clinical practice regulations, minimizing risks to clinical trial data integrity, and ensuring the reliability of clinical trial results; recommendations for communication and early engagement between sponsors and the Food and Drug Administration on the development of seamless, concurrent, or other adaptive trial designs, including review of, and feedback on, clinical trial protocols; and a description of the manner in which the Secretary will assess or evaluate data collected through seamless, concurrent, or other adaptive trial designs to support the development of the drug. The Secretary shall work with foreign regulators pursuant to memoranda of understanding or other arrangements governing the exchange of information to facilitate international harmonization of the regulation and use of decentralized clinical trials, digital technology in clinical trials, and seamless, concurrent, and other adaptive or innovative clinical trial designs.
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- 42 USC 1320d–2
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