Improving Representation in Clinical Trials and Research Building Research Equity for Women and Underrepresented Groups (2022) / Chapter Skim
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6 Recommendations for Improving Representation in Clinical Trials and Clinical Research
6 Recommendations for Improving Representation in Clinical Trials and Clinical Research
Pages 127-134
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From page 127... ...
2. Improving representation in clinical research requires investment.
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From page 128... ...
Transparency and accountability throughout the entire research enter prise will be critical to driving change and must be present at all points in the research life cycle -- from the questions being addressed, to ensuring the populations most affected by the health problems are engaged and considered in the design of the study, to recruitment and retention of study participants, to analysis and reporting of results. Individual investigators and research institutions on the front lines bear responsibility for transpar ency in reporting progress toward the goals of inclusion in research, but this must be reinforced by transparency and accountability that funding agencies and industry sponsors have across their portfolios, that regula tory agencies have in their role governing the conduct of research as well as the approval and reimbursement of the drugs and devices that are often the final products of clinical research, and that journal editors and others that disseminate research have in communicating findings (see Chapters 3, 4, and 5)
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From page 129... ...
The committee presents 17 recommendations to improve the representation of underrepresented and excluded populations in clinical trials and clinical research and create lasting change. The urgency of addressing the equity in research participation and the lack of substantial progress despite stated commitments led the committee to propose bold recommendations with potentially far-reaching implications.
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From page 130... ...
This task force should be charged with the following: a. Producing an annual report to Congress on the status of clinical trial and clinical research enrollment in the United States, including the number of patients recruited into clinical studies by phase and condition; their age, sex, gender, race, ethnicity, and trial location (i.e., where participants are recruited)
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From page 131... ...
3. The NIH should standardize the submission of demographic charac teristics for trials to ClinicalTrials.gov beyond existing guidelines so that trial characteristics are labeled uniformly across the database and can be easily disaggregated, exported, and analyzed by the pub lic. The data reported should include the number of patients; their age, sex, gender, race, ethnicity, and trial location (i.e., where partici pants are recruited)
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From page 132... ...
Incentive pro grams should be designed to improve representativeness in clinical research, improve clinical outcomes, and ensure they do not reduce access to new therapies. Some ideas include: a.
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13. All sponsors of clinical trials and clinical research (e.g., federal, foun dation, private and/or industry)
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From page 134... ...
This funding should go to agencies such as the HRSA, NIH, AHRQ, CDC, and IHS to expand the capacity of community health centers and safety net hospitals to participate in and initiate clinical research focused on conditions that disproportionately affect the patient popu lations they serve.
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