Clinical trials are an integral part of the drug development and approval process. In order for a pharmaceutical company to receive approval from the Food and Drug Administration (FDA) for a developed intervention, it must undergo a series of clinical trials to observe its human health outcomes. The effectiveness of a drug or vaccine depends on whether its clinical trials are representative of the population it is being made for. The inclusion of minority races and ethnicities in clinical trials is a critical need for eliminating disparities in medicine and healthcare.
A 2022 study published in the Lancet Regional Health Journal compared the participation of different races and ethnicities in clinical trials with census estimates of those groups. The study analyzed race/ethnicity data from 8,871 clinical trials between 2000 and 2022. This is approximately 44% of all clinical trials that took place in the time period; less than half of all trials report the races and ethnicities of their participants. The study found that while Black, Hispanic, Asian, and other minority race and ethnicity populations make up approximately 39% of the US population, they make up approximately 2% to 16% of patients in clinical trials.
The discovery of proprotein convertase subtilisin (PCSK9), which revolutionized the understanding of cholesterol homeostasis, would not have been made if there hadn’t been diversity in its research study. The research study that led to the discovery of PCSK9 involved observing cholesterol metabolism differences in a cohort of participants with atherosclerotic risk, or increased risk of developing atherosclerosis. 2% of the Black subjects in the cohort had one of two mutations in the PCSK9 gene, associated with a 40% reduction in low density lipoprotein cholesterol. These mutations are rare among white Americans, and the discovery of PCSK9 would not have been made had there not been a high enough Black participation. The issue of minority inclusion in clinical trials and research studies gained attention in 2020 when it was reported that Black Americans only made up 7% of the participants in Moderna’s trials of their COVID-19 vaccine. According to census estimates, Black Americans make up 13% of the US population.
There are several factors that contribute to low minority participation in clinical trials. Low recruitment of trial participants, regardless of race or ethnicity, is a struggle in itself. Accrual, or enrollment rates for 22% to 50% of proposed clinical trials are insufficient, causing the trials to be canceled. Only approximately 55% of clinical trials meet their originally identified target of participants, and only 78% are able to meet 80% of their participant target. Perceived risk and fear of the drug being tested provides a significant barrier for meeting the participant target of many trials. Prospective participants often have concerns related to unknown side effects of the treatment, which is still in its experimental stage. Another major reason for low clinical trial participation is distrust in the medical field or the public health system. According to a 2014 study published in the New England Journal of Medicine, only 23% of Americans described their trust in the medical system as “a great deal” or “a lot”. Past unethical human abuses and mistreatment of trial participants further decreases trust in medical experiments, particularly among minority populations. The most famous case is the Tuskegee Syphilis Trial, a 40-year trial which took place between 1932 and 1972 and included 600 Black Americans, 399 of whom were diagnosed with the infection Syphilis. The participants in the study were continuously misled about the nature of the trial and denied treatment upon penicillin being discovered as an intervention for Syphilis. Informed consent was not taken from participants in the trial. The healthcare industry’s history of mistreatment against minority groups further decrease willingness to participate in trials among these groups. The process to enter a clinical trial is lengthy and involves a large amount of paperwork, consisting mostly of consent forms. Consent forms often use complex legal terminology and are only available in a few languages, causing language barriers to further impede pharmaceutical companies from being able to recruit diverse participants.
Progress is being made to mend these disparities. In 2020, the FDA updated their advisory to recommend approaches for increasing minority participation in trials, insisting that recruiting a representative population is necessary for the testing of a drug. This change has made it difficult for pharmaceutical companies to get approval from the FDA if their clinical trials do not include sufficient participation from different ethnic groups.
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