Challenging Assumptions About Minority Participation in US Clinical Research

Abstract

Although extensive research addresses minorities' low participation in clinical research, most focuses almost exclusively on therapeutic trials. The existing literature might mask important issues concerning minorities' participation in clinical trials, and minorities might actually be overrepresented in phase I safety studies that require the participation of healthy volunteers. It is critical to consider the entire spectrum of clinical research when discussing the participation of disenfranchised groups; the literature on minorities' distrust, poor access, and other barriers to trial participation needs reexamination. Minority participation in clinical trials is an important topic in public health discussions because this representation touches on issues of equality and the elimination of disparities, which are core values of the field.

Returning to Earth: Setting a Global Agenda for the Anthropology of Cancer

“…Presently only about 3% of the US population participates in clinical trials and the rate is even lower among minorities (Baquet, Henderson, Commiskey, and Morrow 2008;Epstein 2009;Evelyn et al 2001;Fisher and Kalbaugh 2011). Barriers to the participation of ethnic minorities in US trials include unfamiliarity with their purpose, distrust of the medical system in general, and lack of referrals for those who do not have regular access to care (Ford et al 2008).…”

Gender differences in clinical registration trials: is there a real problem?

“…Traditionally, studies have been carried out in predominantly Caucasian countries, using mainly adult white males, especially for phase I clinical trials investigating tolerability, clinical pharmacology, dose‐related side effects and early evidence of efficacy 1. Historically, women of child‐bearing age have been discouraged from participation in phase I trials because of undue risk to fetal development, especially after the thalidomide scandal of the 1960s 2.…”

African American Women's Perceptions and Attitudes Regarding Participation in Medical Research: The Mayo Clinic/The Links, Incorporated Partnership

“…Passage of the National Institutes of Health (NIH) Revitalization Act in 1993 required that scientists receiving NIH funding for their research articulate plans to enroll minorities and women into clinical research studies. [10][11][12][13] While minority enrollment in clinical trials has generally improved, enrollment of African Americans in clinical trials remains suboptimal, particularly in trials related to cardiovascular 14 and cancer outcomes. 15 Underrepresentation of minority groups in research limits the validity and generalizability of study results, affects access to cutting-edge therapies for these groups, and propagates health disparities.…”