Enhancing clinical trial diversity is a moral and scientific imperative. The lack of diversity is an obstacle to understanding the safety and efficacy of novel therapies across population subgroups, which is crucial to reducing disparities and advancing equity. Furthermore, the striking and persistent under-representation of minority racial and ethnic groups in clinical trials is harmful. In the USA, minority racial and ethnic groups comprise nearly 40% of the population; however, 75% of the 32 000 participants in the trials of 53 novel drugs approved in 2020 by the US Food and Drug Administration (FDA) were White.1US Food and Drug Administration
2020 drug trials snapshot. Summary report., 2US Food and Drug Administration
Enhancing the diversity of clinical trial populations—eligibility criteria, enrollment practices, and trial designs guidance for industry. Such over-representation of White participants is in stark contrast to the disproportionate burden of chronic disease in minority racial and ethnic populations, for whom clinical trials could provide life-saving therapies.3Thorpe KE Chin KK Cruz Y Innocent MA Singh L The United States can reduce socioeconomic disparities by focusing on chronic diseases. Health Affairs Blog. For example, according to a recent study,4

Herremans K. Trials and tribulations: diversity and inclusion in pancreatic ductal adenocarcinoma clinical trials. Abstract 901. Digestive Disease Week 2021; May 21–24, 2021.

, 5Healio
Pancreatic cancer trials fall short on diversity. 12·4% of pancreatic cancer diagnoses in the USA are among Black people, who represent only 8·2% of participants in pancreatic cancer clinical trials.Barriers to clinical trial diversity, such as medical mistrust; trial availability, access, eligibility, and enrolment practices; and negative beliefs, norms, and attitudes, present substantial challenges—and yet, they are modifiable.6Clark LT Watkins L Pina IL et al.Increasing diversity in clinical trials: overcoming critical barriers. To this end, proposed interventions have primarily focused on patient, provider, and system-level change. However, they have not resulted in broadly sustainable and scalable solutions.We believe that the engagement of—and bidirectional feedback between—these and other stakeholders including community, government, and pharmaceutical industry partners to be necessary and missing ingredients. This is the essence of community engagement—meaningful partnerships to foster trust, co-create strategies and solutions, and promote change for collective impact.7Clinical and Translational Science Awards Consortium
Principles of community engagement, 2nd edn. Leveraging partnerships between academia, community, government, and industry presents a tremendous opportunity to cultivate and sustain clinical trial diversity.8Joseph JJ Glover A Olayiwola JN et al.Mask up: academic-community-government partnerships to advance public health during COVID-19.

Unfortunately, many in academia, community-serving organisations, government, and the biopharmaceutical industry struggle to establish meaningful partnerships and are therefore unable to move beyond contemplation and into action. We recommend starting by convening key stakeholders and prioritising reciprocity, accountability, sustainability, and awareness of partners' needs and resources. Using this approach, we developed academic–community–government partnerships to advance public health during the COVID-19 pandemic and distributed 46 000 facemasks, 10 000 bottles of hand soap, 18 000 hand sanitisers, and 12 000 dental hygiene items within five target zip codes of communities with the most people susceptible to infection in Columbus, OH. The Ohio Governor subsequently scaled this strategy to more than 60 of Ohio's 88 counties.

We have since adapted this community engagement model to academic–community–government–industry partnerships, to address the lack of diversity in clinical trials. The biopharmaceutical industry in particular, as manufacturers of novel therapeutics and clinical trial sponsors, is well positioned to promote clinical trial diversity. The FDA recently highlighted the important role of the industry in advancing clinical trial diversity through modifications to protocol design, eligibility criteria, and study enrolment practices, which is concordant with many recent industry efforts.

We recently partnered with a pharmaceutical company and with a community organisation, the National African American Male Wellness Agency, on a live, interactive, and community-facing webinar series focused on improving health equity through diversity. The central theme of the inaugural webinar was increasing representation of racial and minority ethnic groups in clinical trials. The programme engaged over 250 global attendees and featured panellists from under-represented minority groups, including a US Congresswoman, a biotechnology industry representative, a clinician scientist, a local community member, and a local news anchor who participated in a clinical trial. Each discussed the importance of clinical trials and their lived experience with, or advocacy for, engagement in clinical trials.

Community members, scientists, clinicians, governmental officials, and biopharmaceutical industry leaders worked together to identify foci for potential solutions. Participants recommended that education on clinical trials included acknowledgment of historical trauma from unethical trial practices in the USA. They ascribed value to engaging grassroots and faith-based organisations in advocacy for clinical trial participation. They endorsed formal training for clinical trial staff on cultural humility, implicit bias mitigation, and recruitment strategies to facilitate accrual of under-represented minorities. They proposed developing culturally sensitive educational materials such as images and statements from under-represented minorities, and leveraging multimedia platforms to disseminate these materials. They advocated for resources that both minimise financial costs for clinical trial participants and that connect academia–community–government–industry partners in sharing best practices to improve diversity in clinical trials. They emphasised the importance of improving the diversity of the staff, scientists, and health-care providers doing clinical trials. Furthermore, they all stressed the fierce urgency of acting promptly to leverage these opportunities to advance inclusive research.

We thank Gerren Wilson, Senior Director of Inclusion & Health Equity at Genentech. DMG reports a consultant relationship with Genentech in 2018–19, unrelated to the contents of this Comment. All other authors declare no competing interests.

References1.US Food and Drug Administration

2020 drug trials snapshot. Summary report.

2.US Food and Drug Administration

Enhancing the diversity of clinical trial populations—eligibility criteria, enrollment practices, and trial designs guidance for industry.

3.Thorpe KE Chin KK Cruz Y Innocent MA Singh L

The United States can reduce socioeconomic disparities by focusing on chronic diseases. Health Affairs Blog.

4.

Herremans K. Trials and tribulations: diversity and inclusion in pancreatic ductal adenocarcinoma clinical trials. Abstract 901. Digestive Disease Week 2021; May 21–24, 2021.

5.

Pancreatic cancer trials fall short on diversity.

6.Clark LT Watkins L Pina IL et al.

Increasing diversity in clinical trials: overcoming critical barriers.

Curr Probl Cardiol. 44: 148-1727.Clinical and Translational Science Awards Consortium

Principles of community engagement, 2nd edn.

8.Joseph JJ Glover A Olayiwola JN et al.

Mask up: academic-community-government partnerships to advance public health during COVID-19.

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DOI: https://doi.org/10.1016/S2468-1253(21)00228-4

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