The Journal of Clinical Pharmacology | 2019
What Drug Development Sponsors, Contract Research Organizations, and Investigators Can Do to Increase Diversity in Clinical Trials
Abstract
Research subjects participate in clinical trials for various reasons, including to learn more about their health condition, to access new cutting-edge treatment options—often as a last resort for serious or lifethreatening conditions—to receive a high standard of care, and to help others with their condition and advance medical science. In the 59 drug products approved by the Food and Drug Administration (FDA) in 2018 and of the 43 966 subjects who participated in these clinical trials, 69% participants were white, 11% were African American, 10%were Asian, and 14%wereHispanic.1 Overall, clinical trial populations slightly skewwhite compared with the demographics of the U.S. population2; however, racial and ethnic minority participation varies widely by trial and therapeutic area. In 2018, minority subjects were generally well represented in infectious disease product approvals (23% of subjects in infectious disease trials were African American, 17% were Hispanic, and 10%were Asian) but not in oncology product approvals (4% of subjects in oncology trials were African American, 4% were Hispanic, and 15% were Asian, although several trials had less than 5% Asian subjects).1 Many current clinical trial populations do not reflect the true demographics and disease prevalence. Clinical trials should reflect the racial and ethnic demographics of the intended treatment population, that is, the population affected by the disease under study who could potentially benefit from the treatment. Racial and ethnic minorities are underrepresented in many clinical trials because of less awareness of and access to clinical trials; a lack of direct recruitment because of provider bias; financial, transportation, and child care burdens; language barriers; health literacy barriers; misunderstandings about clinical research; and medical mistrust.3 In addition, minority populations are less often asked by providers if they want to participate in clinical trials.3