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%).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.