Developing strategies to engage clinical trial participation in underrepresented groups will require a thorough understanding of past challenges, current attitudes, and future implications. Almost 50 years after the unethical research practices in the Tuskegee Syphilis study caused public outrage, remnants of mistrust among African American/Black communities continue to impact confidence in clinical trials. Despite decades of reforms aimed at establishing basic research standards and protecting the rights of trial participants, African American/Black communities remain underrepresented in clinical trials. In a 2020 FDA report on clinical trials resulting in 53 novel drug approvals, African Americans represented only 8% of U.S. clinical trial participants despite comprising 13% of the U.S. population. Across therapeutic areas, the gap between the disease population and trial representation widens. For example, in multiple myeloma (MM) oncology trials, a disease in which Black Americans account for approximately 20% of annual cases, the median percentage of Black Americans enrolled across 21 pivotal trials was just 4.5%. Strategies for proportional clinical trial representation must address cultural barriers to enrollment and improve upon outdated recruitment and retention practices. Increasing African American/Black participation in clinical trials ensures that treatments are adequately tested in populations to whom it will be marketed. Increased diversity in clinical trial populations can also yield racial and ethnic differences in disease progression and drug response across demographic groups.
By convening many of the country’s leading clinical trial and diversity experts, physicians, scholars, authors, and key opinion leaders, this program will provide best practices, new insights, and novel trends in building a more diverse and inclusive clinical trial ecosystem in the U.S.
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