Effective Oversight To Meet Diversity, Inclusion And Equitable Trial Participation Goals

Over the past few years, several government entities have published guidelines and regulations with the goal of achieving more representative populations in clinical trials. In November 2020, FDA published “Enhancing the Diversity of Clinical Trial Populations”, which supported efforts to expand eligibility criteria, improve enrollment practices and trial designs, so that clinical studies would better reflect the population most likely to use the drug if approved.

Over a year later, in May 2022, the FDA proposed further guidelines on patient diversity in clinical trials with the publication of the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. This legislation further authorizes FDA to require sponsors who fail to meet diversity enrollment targets, obtain that data in post-marketing studies.

More recently, however, experts in the pharmaceutical industry have taken these efforts a step further to promote Diversity, Inclusion and Equitable participation. By accessing this article, readers can learn more how, specifically, eClinical is using its clinical data platform elluminate® to ensure appropriate oversight and provide reassurance that every effort has been made to meet the desired recruitment goals.