Minorities Are Severely Underrepresented in Clinical Trials

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Rebecca R. Johnson, Director of Clinical Trial Recruitment at Sun Pharma Advanced Research Company (SPARC), USA and Michelle Lee D'Abundo of Seton Hall University, USA provide context for this ongoing issue, saying, "For three decades now, the National Institutes of Health (NIH) has mandated that members of diverse groups and their subpopulations (distinguished by racial, ethnic, and/or cultural heritage) are included as participants in NIH-funded clinical research. While not mandated, the FDA has also enacted many initiatives aimed at improving representation in clinical trials. Expectations for industry to diversify clinical trials has recently gained more momentum with the Food and Drug Omnibus Reform Act of 2022 (FDORA) being signed into law. We have been ‘admiring this problem’ long enough and this law holds promise to expedite the transition from talk to action. Industry will need to be ready to proactively plan for enrolling clinically relevant populations across their clinical development programs – this is no longer an expectation; it is a requirement."

In recent years, healthcare personnel in the United States have voiced the need to enhance diversity within clinical trial groups to better represent the demographics of a specific disease and/or reflect the broader US population. In December of 2022, the US Congress took steps towards improving clinical trial diversity through policy reform that requires sponsors of most clinical studies to submit a diversity action plan to the Food and Drug Administration (FDA).