UNDER EMBARGO UNTIL 16:00 UK TIME (11:00AM ET) ON WEDNESDAY 7 MAY 2025
A new study led by the University of Southampton has found that the race and ethnicity of participants in clinical trials of medications for mental health and neurodevelopmental conditions often go unrecorded.
In the first comprehensive quantitative review of its kind, an international team of researchers found that just four in ten clinical trials (39%) report the race or ethnicity of the participants involved.
The research was funded by the National Institute for Health and Care Research (NIHR) and published today [Wednesday 7 May] in JAMA Psychiatry. It found that some groups such as Hispanic and Asian people as well as Black children were underrepresented in US-based clinical trials reporting race and ethnicity.
The findings mean scientists don’t know as much as they could about potential differences in how people from different racial or ethnic backgrounds might respond to or tolerate various treatments.
The study, led by Dr Alesso Bellato from the University of Southampton.
Dr Alessio Bellato said: “To tailor treatments for mental health and neurodevelopmental conditions to individual patients, it’s important to understand variations in how different racial or ethnic groups respond to and tolerate medications.”
“The lack of consistent and comprehensive data collection and reporting poses significant challenges for developing and testing inclusive, effective and equitable treatments for people with mental health and neurodevelopmental conditions worldwide.”
Researchers analysed over 1,600 randomised controlled trials of medications for a wide range of mental health and neurodevelopmental conditions, including mood disorders, schizophrenia, anxiety disorders, autism and Attention-Deficit/Hyperactivity Disorder (ADHD).
“It is perhaps unsurprising that most of the trials included in our review (with over 375,000 participants) were conducted in Europe and the United States. Greater efforts are needed to conduct trials in other regions, particularly Central and South America, and Africa,” says Dr Bellato.
The researchers also found that, since 1980, reporting of race and ethnicity had increased each year in the USA, where most studies took place. However, it remained unchanged or even declined in other parts of the world.
NIHR Research Professor Samuele Cortese, a senior author from the University of Southampton says: “Our findings call for an international set of guidelines to provide more comprehensive reporting on race and ethnicity in scientific publications and promote equitable recruitment in clinical trials. This will ensure research better reflects and serves diverse populations globally, mitigates biases and improves the generalisability of study findings.”
The paper Reporting and representation of race/ethnicity in 1683 RCTs of pharmacotherapy for mental disorders: a meta-analysis is published in JAMA Psychiatry and is available online.
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JAMA Psychiatry
10.1001/jamapsychiatry.2025.0666
Systematic review
People
Reporting and Representation of Race and Ethnicity in Clinical Trials of Pharmacotherapy for Mental Disorders
7-May-2025
Dr. Bellato declares honoraria as Joint Editor of JCPP Advances. Prof. Correll has been a consultant and/or advisor to or has received honoraria from: AbbVie, Alkermes, Allergan, Angelini, Aristo, Boehringer-Ingelheim, Bristol-Meyers Squibb, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Darnitsa, Delpor, Denovo, Eli Lilly, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Jamjoom Pharma, Janssen/J&J, Karuna, LB Pharma, Lundbeck, MedInCell, MedLink, Merck, Mindpax, Mitsubishi Tanabe Pharma, Maplight, Mylan, Neumora Therapeutics, Neurocrine, Neurelis, Newron, Noven, Novo Nordisk, Otsuka, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Saladax, Sanofi, Seqirus, Servier, Sumitomo Pharma America, Sunovion, Sun Pharma, Supernus, Tabuk, Takeda, Teva, Terran, Tolmar, Vertex, Viatris and Xenon Pharmaceuticals. Dr. Correll provided expert testimony for Janssen, Lundbeck and Otsuka; he served on a Data Safety Monitoring Board for Compass Pathways, IntraCellular Therapies, Relmada, Reviva, Rovi; he has received grant support from Boehringer-Ingelheim, Janssen and Takeda; he received royalties from UpToDate and is also a stock option holder of Cardio Diagnostics, Kuleon Biosciences, LB Pharma, Medlink, Mindpax, Quantic, and Terran. Prof. Cortese, NIHR Research Professor (NIHR303122), is funded by the NIHR for this research project. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR, NHS or the UK Department of Health and Social Care. Prof. Cortese is also supported by NIHR grants NIHR203684, NIHR203035, NIHR130077, NIHR128472, RP-PG-0618-20003 and by grant 101095568-HORIZONHLTH- 2022-DISEASE-07-03 from the European Research Executive Agency. Prof. Cortese has declared reimbursement for travel and accommodation expenses from the Association for Child and Adolescent Central Health (ACAMH) in relation to lectures delivered for ACAMH, the Canadian AADHD Alliance Resource, the British Association of Psychopharmacology, and from Healthcare Convention for educational activity on ADHD, and has received honoraria from Medice. Prof. Fusar-Poli has received grant support from Lundbeck and honoraria fees from Angelini, Menarini, and Lundbeck outside the current work. Dr. Raduà received CME honoraria from Inspira Networks for a machine learning course promoted by Adamed (outside the submitted work); his work is supported by the CERCA Program / Generalitat de Catalunya and Secretaria d’Universitats i Recerca del Departament d’Economia I Coneixement (2021 SGR 01128). Dr. Solmi received honoraria/has been a consultant for Angelini, AbbVie, Boehringer Ingelheim, Lundbeck, Otsuka. All other authors have no conflicts of interest to declare.