At the American Society of Clinical Psychopharmacology (ASCP) annual meeting held earlier this month, a panel of distinguished psychiatrists presented data and statistics related to disparities in healthcare. As part of their discussion, they focused on clinical trials in a piece just published in The Journal of Clinical Psychiatry.
Clinical Trial Disparities
Racial and ethnic disparities in clinical trials mirror persistent issues within the US healthcare system itself. Lack of diversity in both trial participants and the researchers conducting the studies can skew findings. Medical questions viewed through a narrow lens often return results that have limited value.
For instance, genetic data’s predictive power for complex traits is significantly lower in populations of non-White European descent. This makes it a challenge to accurately assess health information needed to make crucial clinical decisions. Medication efficacy, safety profiles, and pharmacokinetics can also vary between different racial and ethnic groups.
Shockingly, despite this knowledge, most FDA-approved drugs are still tested primarily on White participants. It’s impossible to evaluate potential differences in safety, efficacy, dosing, and other factors for various other racial and ethnic groups. The consequences of this biased approach were evident in recent trials evaluating cancer treatments. The increased risk of toxicity in Black participants went unnoticed due to their low representation in the subject groups.
Data from 2018 reveals that only 41 percent of reported clinical trials included race and ethnicity data from all five commonly reported groups. There was an overrepresentation of White participants and underrepresentation of Hispanic/Latinx, Asian, and American Indian/Alaska Native participants. Similar disparities exist in psychiatric and depression treatment trials, with underrepresentation of Asian, Native Hawaiian, Pacific Islander, and other historically marginalized populations.
However, while underrepresented in most trials, Black individuals are overrepresented in trials using the FDA’s exceptions from the informed consent (EFIC) process. This often yielded ineffective experimental treatments and creates mistrust of science in that community.
Proposed Solutions
The FDA has attempted to address lack of representation. Recently they released draft guidance recommending sponsors submit diversity plans with an eye toward enrolling participants from racial and ethnic populations in proportions representative of the US population. But this doesn’t solve the persistent disparities that persist within the healthcare workforce itself.
There are fewer Asian, Black, and Hispanic psychologists and psychiatrists compared to the general population. Furthermore, grant applications from Black investigators face lower discussion and funding rates compared to their White counterparts. Implicit biases also seem to hinder discussions about clinical trials with BIPOC patients.
The ASCP panel proposed focusing on community engagement as a way to recruit marginalized populations into clinical trials. That said, they recognize the need for even more comprehensive efforts to enhance diversity at all levels of clinical research – and healthcare in general.
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A new podcast episode drops today with NAMI Ambassador, @ALtorresani, she discusses her experience with navigating bipolar disorder during pregnancy.
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