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Tuesday, November 5, 2024

MSU study finds biases affect diversity in clinical trials

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Kevin M. Guskiewicz President at Michigan State University | Official website

Kevin M. Guskiewicz President at Michigan State University | Official website

Randomized controlled trials (RCTs) are considered the gold standard for studying the safety and efficacy of new treatments in clinical research. However, a recent study from Michigan State University (MSU) has revealed significant underrepresentation of people of color and white women in these trials due to systematic biases.

The study, published in the Journal of Ethnicity in Substance Abuse, reviewed 18 RCTs conducted over the past 15 years that tested treatments for post-traumatic stress disorder (PTSD) and alcohol use disorder. Researchers found that although women experience PTSD and alcohol use disorder at twice the rate of men, and people of color face worse chronicity than white individuals, most trial participants were white (59.5%) and male (approximately 78%).

Nicole Buchanan, a professor in MSU's Department of Psychology, commented on these findings: “Because RCTs are the gold standard for treatment studies and drug trials, we rarely ask the important questions about their limitations and failings. For RCTs to meet their full potential, investigators need to fix barriers to inclusion. Increasing representation in RCTs is not simply an issue for equity, but it is also essential to enhancing the quality of our science and meeting the needs of the public that funds these studies through their hard-earned tax dollars.”

The study identified several factors contributing to this lack of representation. Trials were often conducted in areas where white men were the majority demographic group, resulting in study samples that reflected this demographic makeup. Additionally, those designing the studies rarely acknowledged race or gender differences and did not intentionally recruit diverse samples.

Moreover, journals publishing these studies did not have regulations requiring sample diversity or equity as appropriate to the conditions under investigation.

Mallet Reid, co-author of the study and doctoral candidate in MSU’s Department of Psychology, emphasized: “Marginalized groups have unique experiences from privileged groups, and when marginalized groups are poorly included in research, we remain in the dark about their experiences, insights, needs and strengths. This means that clinicians and researchers may unknowingly remain ignorant to how to attend to the trauma and addiction challenges facing marginalized groups and may unwittingly perpetuate microaggressions against marginalized groups in clinical settings or fail to meet their needs.”

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