Sec. 3603. Public workshops to enhance clinical study diversity
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Not later than one year after the date of enactment of this Act, the Secretary, in consultation with drug sponsors, medical device sponsors, clinical research organizations, academia, patients, and other stakeholders, shall convene one or more public workshops to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups, where appropriate, and other topics, including— how and when to collect and present the prevalence or incidence data on a disease or condition by demographic subgroup, including possible sources for such data and methodologies for assessing such data; considerations for the dissemination, as appropriate, after approval, of information to the public on clinical study enrollment demographic data; the establishment of goals for enrollment in clinical trials, including the relevance of the estimated prevalence or incidence, as applicable, in the United States of the disease or condition for which the drug or device is being developed; and approaches to support inclusion of underrepresented populations and to encourage clinical study participation that reflects the population expected to use the drug or device under study, including with respect to— the establishment of inclusion and exclusion criteria for certain subgroups, such as pregnant and lactating women and individuals with disabilities, including intellectual or developmental disabilities or mental illness; considerations regarding informed consent with respect to individuals with intellectual or developmental disabilities or mental illness, including ethical and scientific considerations; the appropriate use of decentralized trials or digital health tools; clinical endpoints; biomarker selection; and studying analysis.
The Secretary shall establish a public comment period to receive written comments related to the topics addressed during each public workshop convened under this section. The public comment period shall remain open for 60 days following the date on which each public workshop is convened. Not later than 180 days after the close of the public comment period for each public workshop convened under this section, the Secretary shall make available on the public website of the Food and Drug Administration a report on the topics discussed at such workshop.
The report shall include a summary of topics and responses to any recommendations raised in such workshop.