Tips and Tools to Overcome DE&I Challenges in Clinical Trials: Navigating FDA's draft guidance and heightened diversity recommendations.

The article highlights 2022 draft which offers a glimpse into when —and how—the Food and Drug Administration-expects sponsors to build a diversity plan into their drug development process. It also recommends that sponsors submit a "race and ethnicity diversity plan" to the investigational new drug application or the investigational device exemption application; and mentions TransCelerate's initiative which recognizes that improving diversity in clinical trials is larger than an R&D issue.