National Academies Progress Report Shows Consequences of Underrepresentation in Clinical Research
The author suggest how to improve the representation of women, older adults, and minorities in clinical research that will require effort from a broad range of stakeholders.
The underrepresentation of women, minorities, and older adults in clinical research has multiple consequences that are significant, emphasizes the author of an analysis published in the Journal of the American Geriatrics Society. The analysis indicates that the underrepresentation in 3 common conditions—diabetes, heart disease, and hypertension—cost an estimated $11 trillion, while also hindering new discoveries in medicine and preventing access to effective intervention methods for patients.1,2
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The analysis was commissioned by the National Academies of Sciences, Engineering, and Medicine (NASEM) Committee and used the Future Elderly Model. The author explains that barriers to the necessary representation of underrepresented and excluded populations in clinical research have reduced participation at multiple levels. Specifically, individual research studies, institutions that conduct research, institutional review boards (IRBs), medical journals, and study funders, as well as the broad landscape of national practices and policies which oversee research all contribute to these barriers the historically excluded face.2
“The goal of my paper is to empower efforts on multiple levels to enhance the representation of women, minorities, and older adults to improve their health outcomes. It serves as a valuable resource of actionable suggestions and reports on the progress that’s been made through coordinated national policy efforts and collaboration from various stakeholders, including research institutions, funding bodies and medical journals,” Jonathan Watanabe, professor of clinical pharmacy practice and director of the Center for Data-Driven Drugs Research and Policy at University of California Irvine, said in a news release.1
Watanabe suggests a more rigorous and standardized approach to ensure clinical trials are inclusive and representations of the populations they intend to serve. He explains a theme present across NASEM is that large medical research centers, such as the National Institutes of Health (NIH), should better leverage funds toward older adults and minorities. Additionally, the NIH can conduct assessments in its annual review to determine if the proposed enrollment goals for race or ethnicity, sex, and gender were met, and should establish a plan for remediation. He urges that journal publishers, editors, and the International Committee of Medical Journal Editors should consider the following: require information on representativeness of studies for journal submissions in the context of the affected population; consider information in acceptance decisions; and publish this information for manuscripts that are accepted, making the overall representativeness “evident” within publications.2
Further, incentive programs can be designed to improve representativeness in clinical research, ensuring they do not hinder access to new therapies. Expedited coverage decisions should be considered for therapies based on clinical programs that achieve representativeness of the populations that are the most affected.2
Watanabe also suggests that federal agencies, such as the FDA and NIH, should develop guidance to direct IRBs on the appropriate payment for study participants. Specifically, this method should focus on the proper compensation for study participants and their caregivers for their commitment and the potential financial burdens of participation. As an example, Watanabe notes that there are trial designs that include adaptive platform trial designs, home-based trials, mechanistic modeling, real-world data, simulations, and pragmatic clinical trials. Some of these changes, notes Watanabe, will require time and effort.2
Watanabe urges that to properly begin bridging these inclusion gaps for older adults, minorities, and women within clinical research, intentional and committed policy efforts with collaborating stakeholders are required. Diversity within the workforce is also critical because it has previously been shown that inclusivity within the workplace improves the ability to understand the populations that are being served. Additionally, he believes that existing informed guidance will aid in these initiatives, helping to reverse flagging population health outcomes.1,2
“Addressing study participant and workforce inclusion gaps is both achievable and necessary. It requires intentional and committed efforts now coordinated by a broad range of stakeholders,” Watanabe said in the news release. “Fortunately, thanks to NASEM and the resulting federal efforts, we have taken a crucial step forward in improving the quality and applicability of clinical studies and now have informed guidance that can be applied to ensuring equitable representation and improving health outcomes for all.”1
