31 Dec Enhancing diversity in clinical trial populations: An agency-industry perspective

By Mathilda Fienkeng, Alysha Croker, Zaida Recinos-Vasquez, and Monique Carter, RAPS

Historically, many clinical trials have not been representative of the patients most likely to use a medical product upon its approval. There is frequent underrepresentation of people from diverse groups defined by factors such as race, ethnicity, sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and comorbidity. The lack of diversity in trial participation has created gaps in the understanding of treatment safety and effectiveness across the different populations. These knowledge gaps ultimately impede the quality of healthcare decision-making and the development of more effective and safer treatments or interventions.¹

Achieving clinical trial diversity will require a multi-stakeholder approach across the healthcare ecosystem. Key efforts to enhance clinical trial diversity by FDA, Health Canada, and Pfizer are outlined in this article. Read more …