Ashley Daigneau , 2025-05-09 13:09:00
Representative clinical studies are important as diseases and medicines can affect people differently depending on their age, sex, and race and ethnicity. According to the Food and Drug Administration (FDA), diversity in clinical trials is not just a regulatory requirement; it is essential for producing reliable data that reflects the varied demographics of the population that will ultimately use these products. Clinical studies that include diverse participants are more likely to yield results that are applicable to the entire patient population.
Recent FDA guidance aims to improve research inclusivity and the generalizability of clinical findings by ensuring diverse participant representation — it’s about better science, improved patient outcomes, and equitable healthcare access.
Pharmacogenetic research in the past few decades has uncovered significant differences among racial and ethnic groups in the metabolism, clinical effectiveness, and side-effect profiles of many clinically important drugs. With so much at stake, and ever-increasing pressure on drug makers and the FDA to hasten the development of new drugs, why does a large percentage of biomedical research not reflect the American population? Too often, minority populations are underrepresented, even in clinical trials for new treatments of diseases, including diseases such as diabetic retinopathy, that disproportionally affect them. This ethnic diversity gap exacerbates minority health issues and drives up the nation’s health care costs. Patient-centricity is at the forefront of transforming clinical trials by putting patients at the center of protocol development and enhancing full representation in research. Without accurate and inclusive data, clinicians cannot confidently prescribe therapies or other treatment options for diseases that affect their minority patients.
Myths have circulated about the guidance — particularly concerns around increased costs and longer recruitment timelines to access underrepresented populations. While there may be some validity to these concerns, in the long run, including historically marginalized communities can improve the generalizability of study findings and potentially reduce costs associated with postmarketing commitments. In fact, between 2019 and 2022, the FDA issued more than 600 postmarketing commitments, many of which were due to insufficient data on specific sub-populations at the time of approval. These commitments often require additional studies to evaluate safety and efficacy in groups that were underrepresented in the original trials, underscoring the importance of inclusive enrollment from the outset.
Achieving diversity in clinical trials is no small feat. Significant hurdles include recruitment barriers, systemic inequities, complex protocols, and cost. To address these challenges and bring greater proactive planning to the initiation of clinical trials, forward-looking sponsors and contract research organizations (CROs) are leveraging de-identified real-world data (RWD), sourced from an array of healthcare settings and electronic health record (EHR) technologies, to provide timely and accurate assessments of eligible patient populations that are most likely to benefit from treatment or have a treatment effect, as well as assessments of patients most likely to drop — representing a critical tool in their fight against wayward studies destined for rescue.
Photo: Rawpixel, Getty Images
Ashley Daigneau is head of clinical trials at Verana Health, where she oversees the strategy and execution of innovative clinical research solutions leveraging real-world data. Ashley has more than 15 years of experience supporting the development of real-world evidence strategies and overseeing clinical study execution.
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