People of Color are Underrepresented in Clinical Trials at the NIH. A Group of Senators Want to Change That
Communities of color are underrepresented in clinical trials at the National Institutes of Health (NIH), despite a requirement by the NIH that members of minority populations be represented in clinical research. Without sufficient representation of racial and ethnic minorities in clinical trials, researchers cannot evaluate differences in the impact of treatments on these groups. A group of lawmakers penned a letter NIH Director Francis S. Collins urging the agency to ensure communities of color are appropriately represented in clinical trials. In a 2018 study published in the Journal of the American Medical Association, researchers examined eligibility criteria for clinical trials in prostate cancer, which disproportionately affects African American men in incidence and mortality compared with men of other racial and ethnic groups. Using a sample of prostate cancer clinical trials collected from ClinicalTrials.gov, the study found approximately 48% of those clinical trials used organ functioning eligibility criteria that disproportionately excluded Black men and did not consider ranges of organ functioning known to be “normal” for certain groups with no additional risk to their safety. In short, Black patients were excluded based on clinically insignificant reasons. In a systematic review of cancer treatment and prevention clinical trials that were conducted between 2001 to 2010 that reported race and ethnicity, researchers at Indiana University-Purdue University Indianapolis found more than 80% of clinical trial participants were Caucasian with less than 12% being African American, Asian, Hispanic, or Native American. “We urge that updated information on eligibility criteria be included in existing resources, ensuring ample opportunities for applicants and reviewers to recognize when proposals may cause barriers to clinical trial participation for racial and ethnic minority groups,” the Senators wrote. “We also ask that existing guidance include information on accounting for variations in organ functioning across population groups when determining eligibility criteria.” Read the full letter here.