Five Key Strategies for Enhancing Diversity in Clinical Trials

A new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Deloitte Center for Health Solutions (CHS) outlines five critical strategies for enhancing diversity in clinical trials during the research and development of new medicines. The report, titled “Enhancing Clinical Trial Diversity: Stakeholder Perspectives on Advancing Research Through Representative Clinical Trials,” is based on a year-long stakeholder engagement effort that included research and feedback from more than 500 stakeholders across 150+ organizations, including community stakeholders, experts in clinical trials and in racial justice, patient advocates, health care practitioners, pharmaceutical companies, academia, and more.

This effort is part of PhRMA’s Equity Initiative and the Deloitte Health Equity Institute, part of CHS. The PhRMA Equity Initiative launched in June 2020 and strives to build upon PhRMA member company efforts by driving real change in several areas, including improving diverse participation in clinical trials. Through the Deloitte Health Equity Institute, Deloitte is expanding its long-standing commitment to help align health care ecosystems to positively impact health outcomes.

“Empowered patients and their families are better prepared to make informed choices about their health care and about participating in clinical trials,” said PhRMA President and CEO Stephen J. Ubl. “By working toward the strategies outlined in this report, we can help improve health outcomes in communities of color and help ensure people who want to participate in trials have the opportunities to do so.”

“The COVID-19 pandemic and racial unrest in 2020 illuminated long-standing health and social inequities in the United States. Enhancing diversity in clinical trials is imperative to help improve health equity and ensure access to potentially life-saving therapies,” said Greg Reh, principal, Deloitte Consulting LLP, and Deloitte global life sciences and health care industry leader. “It is even more important that participants enrolled in clinical trials reflect the intended population, and our research findings outline key next steps that the ecosystem can take to achieve this goal.”

The five strategies in the report outline the parameters for supporting more robust engagement in communities to improve clinical trial diversity and are key to building trust to help ensure clinical trials better reflect patient populations:

• Create a network of clinical trial sites in underserved communities. Establishing research sites in locations where potential participants already receive care, including non-traditional locations such as community health centers and pharmacies, can help improve clinical trial diversity.
• Develop a diverse pool of investigators and staff. Racially and ethnically diverse investigators and staff who reflect the communities they serve are key community ambassadors for clinical trials and can help ensure trials are culturally competent and mindful of unconscious/implicit bias.
• Establish long-term relationships and invest in the community. Stakeholders of a community-based clinical-trial infrastructure should prioritize long-term and sustainable community building efforts, like investing in health education or supporting the next generation of diverse health practitioners and investigators.
• Engage the community in conversations. Sponsors should communicate and work toward shared understanding with the community about the importance of volunteer participation in trials. They should also commit to transparent engagement throughout the process, including design of the trial, desired endpoints and the results of the trial. They should also seek input into the elements of design that might impact community members’ ability to participate.
• Provide sustainable support and standardized platforms. Building a data infrastructure that leverages real world data could facilitate investigators identifying and engaging with patients appropriate for clinical trials and should include baseline measurements to improve data on race and ethnicity.

Building trust and enhancing opportunities for diverse communities to participate in clinical trials are key steps in improving health equity. This report serves as a foundational resource as our industry continues to engage on this issue. Learn more at PhRMA.org/equity.

About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than $1 trillion in the search for new treatments and cures, including an estimated $91.1 billion in 2020 alone.

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