Editor’s note: The opinions expressed by the authors do not necessarily reflect the opinions of the AAMC or its members.
Why are racial and ethnic minorities less likely than the general population to participate in clinical trials? Researchers have tried several strategies to get these populations involved, and while some have been successful, minority participation in clinical research remains low. However, by making an effort to understand the cultural and historical factors at play and involving minority groups in solutions, investigators can go a long way toward encouraging underrepresented groups to participate in clinical trials.
Most researchers today readily acknowledge historical research abuses. The Tuskegee syphilis case is one of the better-known examples, but more recent injustices continue to cause concern about safety and harm in minority communities. Henrietta Lacks, a black woman whose story has been the subject of a book and a movie, died from cervical cancer in 1951. Lacks’ cells were used in research across the world, but investigators did not obtain consent from Lacks before she died or from her family after her death. In the 1990s, the Havasupai Native American tribe consented to research looking into the tribe’s high rate of diabetes. But researchers also used their blood samples for mental illness research and population studies. Although protections and oversights now guide research on human subjects, many investigators fail to recognize that these cases and recent events, such as the Flint water crisis, contribute to continued distrust and concerns.
Why minority participation matters
Health disparities persist in part because racial and ethnic minorities are unwilling to participate in clinical trials that can lead to interventions that improve health. African American, Latino, Hispanic, and Native American populations suffer higher rates of obesity, cancer, cardiovascular disease, asthma, and other diseases than the general population. For example, the American Diabetes Association reports that American Indians/Alaskan Natives account for 15.9% of diabetes cases, while non-Hispanic whites account for 7.6% of diagnosed cases.
Health professionals and researchers with cultural humility will have the skills to appreciate and consider the multiple factors—values, beliefs, and sociocultural characteristics—underlying diversity among individuals and groups and to make minority inclusion an explicit, thoughtful process during the design of clinical trials.
Nearly 25 years ago, the National Institutes of Health (NIH) issued a policy requiring that all NIH-funded clinical research include women and minorities, but there are still frequent reports of failure to enroll minorities. Without minority participation, researchers cannot adequately test new prevention methods and treatments in underrepresented groups, although this is important because efficacy and safety can vary among different racial and ethnic groups. For example, a Mayo Clinic Proceedings study found that about 86% of Asian Americans are sensitive to a common blood thinning medication, which means they could be at risk for bleeding if they take the same dose prescribed to white patients. Low participation rates among minorities can limit the generalizability of research results and may bias measures of efficacy, harm, and cost-effectiveness.
Fundamental issues related to minority recruitment in clinical trials are well-documented and include ineffective communication, lack of trust in research, as well as practical factors such as time commitments and awareness of trial opportunities. Other barriers involve complexities of the health system and the research process: navigation of academic health systems, insurance coverage, restrictive inclusion or exclusion criteria, and complicated consent forms.
A particularly challenging obstacle among clinical research teams is the lack of cultural humility—a commitment to self-evaluation and to valuing the unique characteristics of individuals across diverse populations. The ways in which researchers deliver information about clinical trials or consider individuals’ cultures and beliefs, among other factors, affect minority participation rates. Researchers often underestimate the time and resources required to engage minorities and may lack empathy regarding concerns these populations have related to safety and harm. Investigators who are well trained in research methods may have little experience engaging minorities and may be unaware of the cultural nuances and needs of minority groups for participation in clinical trials.
Fostering cultural humility
Despite these ongoing challenges, a number of approaches have proven successful in recruiting minorities. Underrepresented groups have been more likely to participate when researchers engage with communities to develop tools and strategies that facilitate recruitment and increase community knowledge and awareness of clinical trials. Researchers have also been effective in increasing minority participation by moving recruitment events from clinics to community centers and culturally tailoring recruitment materials.
Cultural humility, which requires openness, self-awareness, and being egoless, has long been considered critical for clinicians to gain patients’ trust and was recently identified as foundational for clinical researchers across all disciplines. Health professionals and researchers with cultural humility will have the skills to appreciate and consider the multiple factors—values, beliefs, and sociocultural characteristics—underlying diversity among individuals and groups and to make minority inclusion an explicit, thoughtful process during the design of clinical trials. A researcher who embraces cultural humility will seek to understand the needs and values of groups underrepresented in research and will consider these in all stages of research, from the conception of the clinical trial through dissemination of the research findings. This inclusive approach transforms recruitment from an activity with the primary goal of enrolling participants to engagement, which entails more meaningful, authentic involvement of minorities.
Multifaceted, innovative solutions that tackle all elements of clinical research—from direct communication with participants to study design to changes in research policies—are needed to overcome the ongoing challenges of minority recruitment. These transformational changes will lead to research teams fully equipped with the skills to do the following:
- design clinical trials with inclusion and exclusion criteria that reflect diverse populations,
- create recruitment plans that include preferred communication strategies and incentives, and
- develop policies that increase transparency, enhance privacy protections, and facilitate trust.
For these efforts to be successful, clinical investigators and research teams must be trained in cultural humility. Academic medical centers should integrate training in cultural humility into standard clinical research curricula. Investments in this training will nurture an inclusive research culture that promotes equitable research and evidence. Ultimately, it is up to investigators to include all groups affected by specific health conditions in clinical trials, thereby ensuring that the potential benefits of research are available to the entire population.