Lack of Diversity in Clinical Trials: FDA Releases 2023 Drug Trials Report

FDA Releases 2023 Drug Trials Snapshot Summary Report Showing Lack of Diversity in Clinical Trials

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has published its 2023 drug trials snapshots (DTS) summary report, shedding light on the demographics of patients involved in clinical trials for the 55 drugs approved that year. The report emphasizes the ongoing efforts to enhance diversity in US clinical trials, providing insights into the sex, race, ethnicity, and age of the patients. Despite some progress, the report reveals that white patients still represented over 50% of the trial population for all programs except three, while black and Hispanic or Latino patients continued to be underrepresented. However, the FDA's presentation of these demographics will enable the tracking of diversity in clinical trials by therapeutic area.

Key Takeaways

• The 2023 DTS summary report released by FDA's CDER showcases diversity statistics for 55 drugs approved in 2023, including gender, race, ethnicity, and age data from 44,000 patients.
• Efforts to improve diversity in trials remain a pivotal focus within the industry, characterized by the conduct of all pivotal trials at multiple sites.
• White patients dominated the trial population in all programs except Loqtorzi, Augtyro, and Xacduo, while Asian patients emerged as the second largest race enrolled in pivotal trials, with over 30% participation in six programs.

Analysis

The underrepresentation of minority groups in US clinical trials, as highlighted in the FDA's 2023 DTS summary report, raises concerns regarding the potential impact on the accumulation of data concerning drug efficacy and safety for these underrepresented populations. Such lack of diversity may result in insufficient information for healthcare providers, potentially leading to disparities in the administration of appropriate dosages and management of side effects for minority patients, thus affecting their overall health.

Did You Know?

• Center for Drug Evaluation and Research (CDER): This branch of the U.S. Food and Drug Administration (FDA) is accountable for ensuring the safety and effectiveness of drugs approved for human use in the United States. CDER assesses new drugs before their release into the market and monitors their post-market safety.
• Drug Trials Snapshots (DTS) Summary Report: This annual report released by the FDA's CDER provides statistics on the demographics of patients involved in clinical trials for drugs approved in a given year, including data on sex, race, ethnicity, and age. It serves the purpose of tracking diversity in clinical trials by therapeutic area.
• Pivotal Trials: These are phase 3 clinical trials conducted to verify the safety and efficacy of a new drug. Pivotal trials are typically carried out at multiple sites, encompassing a diverse patient population, to ensure the generalizability of the results to the larger population. In the context of the DTS summary report, pivotal trials are utilized to assess the diversity of patients involved in clinical trials for drugs approved in a given year.