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FDA report highlights need to improve diversity in clinical trials

By Abigail Beaney, Clinical Trials Arena

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is continuing a push to improve diversity in US clinical trials.

The agency has released the 2023 drug trials snapshots (DTS) summary report which illustrates the demographic groups represented in clinical trials for the 55 drugs approved in 2023 involving 44,000 patients.

The summary provides statistics for patients’ sex, race, ethnicity and age in clinical trials of the approved drugs. Improving diversity in trials has been one of the key areas the industry is working on over the past few years.

All the pivotal trials supporting each of the novel therapy approvals were conducted at multiple sites and the majority were multinational. Read more…