This work began at an MRCT Center Bioethics Collaborative, a neutral forum during which a number of clinical research stakeholders convened to discuss diversity in clinical trials.
The attendees of that meeting, represented by a multi-stakeholder group of industry, academia, government, and patient advocacy, agreed that the participant population enrolled in a clinical trial ought to be representative of the general population at a minimum and, optimally, of the intended population for the intervention.
If study populations are skewed, if they lack diversity, then the safety and efficacy, effectiveness, and value of medical interventions—the biological heterogeneity of treatment effect— cannot be adequately investigated and understood. Justice issues also influence diversity – or lack thereof – of study populations, with a fundamental unfairness perceived if specific populations are either disproportionately burdened, or unfairly excluded, from study enrollment.
The attendees at that meeting agreed that, despite the understood necessity as a matter of science and ethics, underrepresentation of gender, sex, ethnic, and racial minorities in drug development, and in clinical research more generally, persists.
The Diversity, Inclusion, and Equity in Clinical Research project was established as an output of that meeting. Click here to learn more about our Bioethics Collaborative.