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3 Policies to Improve Clinical Trial and Research Diversity: History and Future Directions
Pages 47-74

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From page 47...
... The full research paper can be found online at: nap.nationalacademies.org In this chapter, the committee describes major federal policies designed to improve the inclusion of underrepresented and excluded populations in clinical trials and analyze the benefits and limitations of these policies with the aim of improving them. The history of trial diversity policies is deeply embedded in the broader historical context of work toward equity and inclusion.
From page 48...
... The report pointed out that "the selection of research subjects needs to be scrutinized to determine whether some classes (e.g., welfare patients, particular racial and ethnic minority population groups, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979)
From page 49...
... . In 1979, the Belmont Report further stipulated that pregnant women should be considered vulnerable research subjects and should be protected at all costs (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979)
From page 50...
... . Its stewardship over clinical trial policies has a substantial impact on the rigor, transparency, and effectiveness of the clinical trial enterprise (Hudson et al., 2016)
From page 51...
... . The task force recommended increased participation of women in clinical trials, including women of childbearing potential.
From page 52...
... In addition to persistent barriers for minority participation in cancer clinical trials, the study reported a dearth of cancer clinical trials that focus primarily on racial/ethnic minority populations, as well as a lack of usable trial data about racial/ethnic minority populations (Chen Jr.
From page 53...
... Thus, the updates provided guidance on clarifying the definitions of racial and ethnic categories and reporting analyses of sex and racial minority population groups in clinical trials (Nours, 2021)
From page 54...
... . This act instructed the NIH to hold a workshop accounting for differences across the lifespan, publish guidelines addressing consideration of age in clinical research, and ensure that researchers conducting applicable Phase 3 clinical trials report results of analyses by sex/gender at ClinicalTrials.gov (Nours, 2021)
From page 55...
... The Sex as a Biological Variable (SABV) policy, which was passed in January 2016, plays an important role in consideration of preclinical research and the design of clinical trials.
From page 56...
... Phase 3 clinical trials are required to report results of sex/gender and race/ethnicity data into ClinicalTrials.gov so that this information can be monitored (Nours, 2021)
From page 57...
... Food and Drug Administration The FDA has been working for decades to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. The official stance of the FDA is that clinical trial participants should be representative of the patients who will ultimately use the medical products that the FDA evaluates, because people of different ages, ethnicities, or races can react differently to medical products for a variety of reasons (NIH, 2020b)
From page 58...
... . Although the 1988 and 1989 guidance documents aimed to promote evaluation of drug effectiveness based on gender, a landmark GAO report in 1992 concluded that women were nonetheless being underrepresented in clinical trials and trial data were often not analyzed for differences in therapeutic response by sex (GAO, 1992)
From page 59...
... Women and Minorities Regulation," that required the FDA and NIH to review and develop guidance on the inclusion of women and minorities in clinical trials.1 To comply with this regulation, the FDA issued the Demographic Rule in 1998, revising the New Drug Applications (NDA) content to require safety and efficacy data to be presented by gender, age, and racial subgroups and dosage modifications to be identified for specific subgroups (FDA, 1998)
From page 60...
... . A final draft guidance was released in 2018 titled "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials" that supported an informed and balanced approach for gathering data on the use of medical products during pregnancy by encouraging judicious inclusion of pregnant women in trials and careful attention to fetal risk (FDA, 2018)
From page 61...
... To fulfill these directives, the FDA drafted a report, Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products, to address the extent to which demographic subgroups participated in clinical trials and whether the relevant subgroup analyses were performed in a manner consistent with FDA regulations (FDA, 2013)
From page 62...
... . A final guidance was issued in 2020 titled "Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry," specifically addressing the need to enhance diversity of clinical trial populations by modifying eligibility criteria, enrollment practices, and trial designs (FDA, 2020c)
From page 63...
... . Enforcement, Incentives, and Accountability Thus far, the FDA has undertaken various measures to improve diversity in clinical trials primarily via guidance documents and the use of Drug Trials Snapshots.
From page 64...
... Setting guidelines for submission across trials of medical products and drugs could help standardize data collection, which could further aid in analysis. Although the FDA has made major progress in ensuring more inclusivity within clinical trials, it must continue to try to enforce its recommendations to ensure that trial populations reflect the diversity of populations at large.
From page 65...
... . The ordinances stated that women and members of racial and ethnic minority population groups should be adequately represented in all CDC research involving human subjects, in the absence of a compelling reason for exclusion.
From page 66...
... . While the CDC's public health research and initiatives have received a plethora of academic attention, there has been less research on the clinical trial policies of the CDC.
From page 67...
... . The exception is thought to have created major barriers that prevented community providers from participating in clinical trial enrollment, which in turn disproportionately affected racial and ethnic minority population groups.
From page 68...
... Subsequently, the AHRQ has required that all AHRQ-supported research includes priority populations unless a compelling justification is provided against inclusion. Priority populations initially included women, children, and racial and ethnic minority population groups; populations with special healthcare needs (chronic illness, disabilities, and end-of-life care needs)
From page 69...
... One notable change in the 2018 revision was the removal of pregnant women from the "vulnerable" category of research subjects. This was in response to criticism that women were being unfairly excluded from research studies, to the detriment of designing treatments for women (NIH, 2019a)
From page 70...
... According to a 2018 review, "when special populations have been included into clinical trials, numerous age-dependent, community, cultural and genetic features have come to light." However, including these populations on clinical research requires consideration and use of best practices, such as building trust, conducting clinical trials that are relevant to special population, providing incentives and compensation, as well as offering options for participants to easily opt-out of the research (Winter et al., 2018)
From page 71...
... 18) , which recognize tribal nations as sovereign "domestic dependent nations under the protection" of the United States, and as sovereign nations, "exercise inherent powers over their members and territory" (Executive Order 13084, May 14, 1998)
From page 72...
... . It is not difficult to understand why tribal members experience significant health disparities.
From page 73...
... What is or is not agreed upon with one tribe will not necessarily transfer to another tribe. And, there are no tribal- or federal-wide agreements for the inclusion of or data protections for tribal members who individually enroll in clinical studies not specific to tribes or tribal nations, such as the 19,806 American Indian/Alaska Native who participated in NIH-funded research in 2017.


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