Both the public and private sectors have shown a renewed focus on expanding the diversity of clinical trial participants.  To date, most research on medical treatments, interventions, and cures has not appropriately represented all communities of patients, especially racial and ethnic minority populations (Figure 1). Clinical trials that do not include a diverse range of participants may overlook relevant patient perspectives and risk unpredictable post-market product results in populations that were not included in initial studies.

* Note: Of the 20,692 US-based trials represented, only 43% (8,898) reported any race/ethnicity data.

1. US Census, Quickfacts (date accessed: May 18, 2022).
2. E.B. Turner et al., “Race/Ethnicity Reporting and Representation in US Clinical Trials: A Cohort Study,” The Lancet Regional Health: Americas 8.100252 (2022).

Legislative and Regulatory Outlook

In addition to past decades of policymaking to tackle ethical issues and increase equity in clinical trials, the Biden administration, federal agencies, and professional organizations are prioritizing diversity by highlighting specific initiatives to improve equity in clinical trials. For example, the Food & Drug Administration (FDA) released guidance for including older adults in cancer clinical trials, while the National Institutes of Health released a strategic plan on minority health and health disparities, which includes ensuring appropriate representation of minority populations. Additionally, PhRMA released an equity initiative that includes clinical trial diversity.

Currently being considered at the federal level are FDA draft guidance and multiple bills to support enhancing equity in clinical trials. The FDA released draft guidance in April on how medical product sponsors can develop race and ethnicity diversity plans to enroll clinical trial participants from underrepresented racial and ethnic groups. Additionally, several bills have been proposed to enhance diversity in clinical trial populations, including the House FDA User Fee Amendment (UFA) Package (H.R.7667).

Public comments were collected for the FDA’s draft guidance in June, and it is expected final guidance will be released after review. Conversely, little movement has occurred with the bills proposed to enhance diversity in clinical trial participation. Additionally, the Senate’s version of the FDA UFA package does not include the House’s clinical trial diversity provisions. While these proposed bills aim to increase diversity in clinical trials, this lack of advancement creates an opportunity for life sciences companies and other stakeholders to lead efforts to identify and implement solutions.

Barriers and Approaches to Improving Equity

Improving equity in clinical trials requires considering barriers to patient participation at multiple levels (Figure 2) and identifying strategies to help address specific issues at each level. For example, at the institutional level, leaders can increase diversity of research teams and expand resources for research (e.g., staffing, financial supports).

BIPOC: Black, Indigenous, and People of Color. Sources: D.H. Bodicoat, A.C. Routen, A. Willis, et al., “Promoting Inclusion in Clinical Trials: A Rapid Review of the Literature and Recommendations for Action,” Trials 22.880 (2021); N. Thakur, S. Lovinsky-Desir, et al., “Enhancing recruitment and retention of minority population for clinical research in pulmonary, critical care, and sleep medicine: An official American Thoracic Society research statement,” Am J Respiratory and Critical Care Medicine 204.3 (2021); 204(3).

Life sciences companies may consider both qualitative and quantitative approaches to increasing clinical trial diversity. For example, manufacturers can lead qualitative research with patients and providers to understand how their needs vary among different subgroups or assess patient data to understand social needs within potential study populations. As stakeholders consider future clinical trial design, including diverse populations will be important to ensuring that products are effective for a broad range of patients.

To talk with our experts about identifying barriers to trial participation and options for addressing those barriers, connect with us.

The information featured in this Insight comes from Avalere Federal Policy 360™. For information on subscription pricing or for in-depth context and recommendations on advancing equity in clinical trials, contact us.