Lack of diversity in clinical trials


In the FDA 2018 Drug Trial Snapshots report, it was demonstrated that there’s a significant imbalance in the representation of racial and ethnic minorities in clinical research. Participants in clinical trials should reflect the diversity of the population, but this lack of representation has led to the development of drug interventions that may cause safety or efficacy issues for underrepresented populations. It's not just potential genetic predispositions of certain racial/ethnic groups to specific adverse events, but differences in experiences and exposure to environmental stressors among racial/ethnic groups may not be accounted for when clinical trials do not test their drug interventions on diverse participants. 

A 2021 cross-sectional study looked at 230 vaccine clinical trials between 2011 and 2020, and the results highlighted disparities over the past decade where Black or African American, American Indian or Alaska Native, Hispanic or Latinx populations, and older adults were underrepresented compared to the US population in vaccine clinical trials. It was also found that ClinicalTrials.gov was consistently lacking in reporting race and ethnicity information, with missing ethnicity data in 60% of trials and missing race data in 40% of trials. So it's difficult to gauge the actual representation of clinical trial participants. 

People of color have been disproportionately affected by the pandemic, and scientists have agreed that the COVID vaccine clinical trials should overrepresent people of color compared to their population share. However, Pfizer and Moderna's demographic data for participants in their clinical trials show that overall, people of color are still underrepresented in these trials, with the largest disparity among Black or African Americans. It is noted that these vaccine clinical trials have greater diversity in representation compared to previous clinical trials and how clinical trials have historically been.

References: 
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2776562
https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/
https://www.contagionlive.com/view/minorities-are-underrepresented-in-vaccine-clinical-trials
https://acrpnet.org/2020/08/10/representation-in-clinical-trials-a-review-on-reaching-underrepresented-populations-in-research/

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