Diversity in Clinical Trials: Life Sciences Initiatives and Challenges in Light of the FDA’s Latest Guidance

To date, life sciences’ efforts towards driving equitable healthcare have centered around access to care, early identification and prevention. Meanwhile, less attention has been given to the impact of the racial and ethnic homogeneity in trial populations. Clinical trial diversity continues to be one of the greatest challenges pharmaceutical and biotech companies face in ensuring the delivery of medicines that are effective for all people. Diverse clinical trial populations are an integral step in achieving equitable healthcare treatment.

While we understand “diversity” to be more broadly inclusive of women, disabled persons, rural populations and racial minorities, when assessing the diversity of clinical trials, the FDA focuses mostly on racial and ethnic minorities, which will be the focus of this white paper.

While efforts to improve racial and ethnic diversity in trials have increased in the last decade, disparities still remain. Although over 40% of the United States (U.S.) population is currently comprised of ethnic and racial minorities, often only 5 to 10% of clinical trial participants represent any minority population. This disparity is striking and exposes the non-white population to harm as a result of an uncomfortable gap of knowledge around what is effective and ineffective (or even dangerous) in minority patients.

In 2022 the U.S. Food and Drug Administration (FDA) released draft guidance for the pharmaceutical industry outlining tactics and plans to improve clinical trial participation from underrepresented racial and ethnic populations within the U.S. Clinical trial diversity is not a new topic for pharmaceutical companies who have implemented strategies to address it throughout the past decade. However, as the FDA’s focus has shifted to this topic, with clearer guidelines coming into view, there has been a significant uptick in pharmaceutical engagement on the topic.

This paper is a follow up to Diversity in Clinical Trials Participation: A Life Sciences Perspective focused on understanding what is being done to recruit and retain diverse trial populations from the perspective of African American/Black and Hispanic/Latinx former clinical trial participants, clinical trial coordinators and principal investigators (physicians). From that research, we learned where the gaps are and provided some prescriptive guidance on what initiatives would help increase the number of diverse trial participants.

For this paper, our research sought to understand what initiatives are being undertaken at the corporate level to improve the diversity of trials, the effectiveness of those initiatives and the impact of the FDA’s guidance to improve diversity now and in the future.

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