WASHINGTON, D.C. (Date, 2021) – A new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA) and Deloitte Center for Health Solutions 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 has included research and feedback from more than 500 stakeholders across 150+ organizations, including community stakeholders, experts in clinical trials, racial justice experts, health practitioners and pharmaceutical companies.

“This research is an important step in our industry’s broader effort to address disparities within the U.S. health care system,” said Richard A. Moscicki, M.D., PhRMA’s executive vice president of science and regulatory advocacy and chief medical officer.

“Empowered patients and their families are better prepared to make informed choices about their health care and about participating in clinical trials. 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.” 

DELOITTE QUOTE

The five strategies outlined in the report build toward a community-based infrastructure and are key to building trust with communities to help ensure clinical trials better reflect patient populations:

• Creating 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 federally qualified health centers (FQHCs), can help improve clinical trial diversity.
• Developing 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.
• Establishing long-term relationships and investing 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.
• Engaging the community in conversations. Sponsors should communicate with the community about the importance of volunteer participation and should share the results of trials conducted in the community. They should also seek input on clinical trial design, including endpoints of interest and elements of design like testing requirements that might impact patients’ ability to participate.
• Providing sustainable support and standardized platforms. Building a data infrastructure that leverages real world data could make it seamless for investigators to identify and engage with patients appropriate for clinical trials and should include baseline measurements to improve data on race and ethnicity.

Building trust and enhancing opportunities to participate in clinical trials are key steps in improving health equity. This community-based report serves as a resource as our industry continues work 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 $91.1 billion in 2020 alone.

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