Race and Ethnicity Often Not Reported in Clinical Trials for Mental Health Medications

A recent comprehensive review led by the University of Southampton has highlighted a significant gap in the reporting of race and ethnicity data in clinical trials for mental health and neurodevelopmental treatments. The study, published in JAMA Psychiatry, analyzed over 1,600 randomized controlled trials and found that only approximately 39% of them included information on participants’ racial or ethnic backgrounds. This lack of detailed demographic reporting is particularly concerning for underrepresented groups such as Hispanic, Asian, and Black populations, especially within U.S.-based studies.

The absence of consistent data on race and ethnicity limits our understanding of how different populations respond to mental health medications, impeding the development of tailored and effective treatments. Dr. Alessio Bellato emphasized the importance of recognizing variations among racial and ethnic groups to improve efficacy and tolerability of therapies. The study also revealed that although reporting on race and ethnicity has increased in the U.S. since 1980, progress remains uneven globally, with many regions still lacking comprehensive demographic data.

Most of the trials reviewed—over 375,000 participants—were conducted in Europe and the United States. The researchers stress the need for international guidelines to improve the reporting standards and promote equitable recruitment across diverse populations. Such measures would enhance the generalizability of research findings and ensure treatments are effective for all.

Senior author NIHR Research Professor Samuele Cortese called for global efforts to establish better reporting practices in scientific publications and clinical trials. This initiative aims to reduce biases, improve inclusivity, and better serve diverse patient populations worldwide.

For more details, see the study titled "Reporting and Representation of Race and Ethnicity in Clinical Trials of Pharmacotherapy for Mental Disorders" in JAMA Psychiatry (2025). Source: https://medicalxpress.com/news/2025-05-ethnicity-trials-medications-mental-health.html