Achieving diversity equity and inclusion in clinical trials

The prevalence of communicable and non-communicable diseases are increasing worldwide, placing considerable demand on public health systems and driving a necessity to develop more effective targeted therapies. This is reflected in the exponential growth of registered clinical trials in the last two decades – from 2,673 in 1999, to 600,713 in 2020. 1 Clinical trials are the cornerstone of precision medicine and are not possible without the volunteers who take part. As defined by the US National Institutes of Health (NIH), precision medicine is “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.”2 By considering this variability, the core of executing precision medicine is collecting data from a diverse study population representing real-word patients. However, despite growing initiatives and practices to make trials more patient-centric and representative of today’s societies, most studies still fail to enroll inclusive and diverse patient
populations. To illustrate, in 2020, minority racial/ethnic groups represented only 25% of patients in clinical trials,3 despite comprising 40% of the US population4 – limiting the generalizability and applicability of new treatments in underrepresented groups. Furthermore, this lack of diversity contributes towards growing social and health disparities, particularly among underrepresented, underserved, and minority populations who tend to bear the unbalanced brunt of some of the most common conditions and diseases (e.g., diabetes, cardiovascular disease, etc.). To improve social and health equity for everyone, the clinical trial research industry first needs to ensure that medicines and therapies are effective in the patients who need them most. This requires a nuanced and targeted approach to understand who these patients are.