Clinical Trials Arena

FDA report highlights need to improve diversity in clinical trials

There has been a real push among the industry to improve diversity in trials. The FDA report shows diversity statistics from US trials.

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.

White patients comprised more than 50% of the trial population enrolled for all programs except Loqtorzi (0%), Augtyro (33.9%) and Xacduo (49.2%).

Asian patients were the second largest race enrolled in pivotal trials. In six programmes, over 30% of patients enrolled were Asian, Fabhalta (33.6%), Filspari (34.5%), Xacduro (43.5%), Augtyro (59.1%), Fruzagla (43.1%), and Loqtorzi (100%).

Nine programmes enrolled less than 10% of black patients, however two programmes enrolled over 25% of black patients, Defencath (29.5%) and Zurzuvae (30.1%).

Eighteen drug programs enrolled less than 10% Hispanic or Latino patients; five programs enrolled more than 30% Hispanics, Inpefa (31.1%), Filsuvez (34.5%), Defencath (45.4%), Paxlovid (41.8%), and Zurzuvae (31.6%).

Participation in clinical trials of individuals from American Indian or Alaskan Native race has historically been under 1% to 2%. In 2023, Paxlovid enrolled a notable percentage from the American Indian or Alaskan Native category (7.3%).

Although highlighting the continued lack of diversity in trials overall, interpretation of racial and ethnic patient populations should also consider prevalence of the disease in these racial and ethnic populations.

The FDA said that presenting these demographics will allow the tracking of diversity in clinical trials by therapeutic area.

The CDER created the DTS transparency initiative in 2015 to report on the diversity of participants in clinical trials.