Ethically and scientifically, clinical research is only possible if there is diversity. Researchers lack the ability to understand how novel treatments will affect these populations if there is not enough representation of ethnic and racial minorities. From a scientific standpoint, an incomplete dataset hinders drug delivery and the development of breakthrough therapies – but from an ethical standpoint, underrepresentation creates a barrier to treatment options for populations that are often the most vulnerable and predisposed to health challenges.Â
In a 2021 study, 40% failed to report the race of trial participants. Of those who did report, 78% were white. Stakeholders have been trying to overcome and resolve barriers to representative enrollment in clinical trials for over a decade. With the FDA’s April 2022 release of draft guidance, regulators have placed greater importance on diversity in clinical trials. Data show that clinical trial enrollment is…
