Enrolling Minority and Underserved Populations in Cancer Clinical Research

Abstract

Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials—a “gold standard.” Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. It is increasingly necessary to be aware of defining characteristics such as location and culture of the populations from which research participants are enrolled. Little research has examined the effect of location and cultural competency in adapting clinical trial research for minority and underserved communities on accrual for clinical trials. Utilizing embedded community academic sites, the authors applied cultural competency frameworks to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials. This strategy resulted in successful accrual of participants to new clinical research trials, specifically targeting participation from minority and underserved communities in metropolitan Washington, DC. From 2012 to 2014, a total of 559 participants enrolled across six non-therapeutic clinical trials, representing a 62% increase in the enrollment of blacks in clinical research. Embedding cancer prevention programs and research in the community was shown to be yet another important strategy in the arsenal of approaches that can potentially enhance clinical research enrollment and capacity. The analyses showed that the capacity to acquire cultural knowledge about patients—their physical locales, cultural values, and environments in which they live—is essential to recruiting culturally and ethnically diverse population samples.

Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual

“…Recently, the Clinical Trials Transformation Initiative (CTTI), a public-private partnership of more than 60 organizations from across the clinical trial enterprise, released a set of recommendations to guide study teams on how to efficiently and effectively plan for clinical trial recruitment (31). Attention should also be paid to enhancing accrual for minority and underserved patients who may otherwise be underrepresented, particularly in early phase trials (32, 33). Although more research is needed to further develop the evidence base for accrual, a number of resources and a curated library of relevant journal articles are available at NCI’s AccrualNet website (34, 35).…”

Inclusiveness and ethical considerations for observational, translational, and clinical cancer health disparity research

“…This can be accomplished by using various culturally competent approaches to engage minority patients in clinical trials. There are examples of success in minority‐driven recruitment in clinical trials . The culturally competent approaches also aid in enriching minority participation in biospecimen donation for LHS‐based observational research .…”

“…5,6 Underserved groups include racial/ethnic minorities, the young, the elderly, those with comorbidities, and those with rural residence. 7 Emerging approaches such as precision medicine offer promise for cancer treatment and prevention, yet they can exacerbate existing disparities. To the best of our knowledge, few genomic and molecular-based translational approaches are constructed with specimens from nonwhite research participants.…”

A Community-Based Outreach Navigator Approach to Establishing Partnerships for a Safety Net Mammography Screening Center

“…Our previous work [23] has noted that huge investments have to be made in terms of institutional commitment, space, human capital, and time and effort in order to build community capacity and relationships with diverse stakeholders within communities.…”