Applying a Conceptual Framework to Maximize the Participation of Diverse Populations in Cancer Clinical Trials

Abstract

The underrepresentation of ethnically diverse populations in cancer clinical trials results in the inequitable distribution of the risks and benefits of this research. Using a case study approach, we apply a conceptual framework of factors associated with the participation of diverse population groups in cancer clinical trials developed by Dr. Jean Ford and colleagues to increase understanding of the specific strategies, and barriers and promoters addressed by these strategies, that resulted in marked success in accrual of racially and ethnically diverse populations in cancer clinical research. Results indicate that the studies presented were able to successfully engage minority participants due to the creation and implementation of multi-level, multifaceted strategies that included: culturally and linguistically appropriate outreach, education, and research studies that were accessible in local communities; infrastructure to support engagement of key stakeholders, clinicians, and organizations serving minority communities; testimonials by ethnically diverse cancer survivors; availability of medical interpretation services; and providing infrastructure that facilitated the engagement in clinical research of clinicians who care for minority patient populations. These strategic efforts were effective in addressing limited awareness of trials, lack of opportunities to participate, and acceptance of engagement in cancer clinical trials. Careful attention to the context and population characteristics in which cancer clinical trials are conducted will be necessary to address disparities in research participation and cancer outcomes. These studies illustrate that progress on minority accrual into clinical research requires intentional efforts to overcome barriers at all three stages of the accrual process: awareness, opportunity and acceptance of participation.

The Representation of Gender and Race/Ethnic Groups in Randomized Clinical Trials of Individuals with Systemic Lupus Erythematosus

“…We found that the representation of blacks among RCT participants has decreased since 2006-2011 in the USA, which is consistent with reviews of race/ethnic representation in other disease states [16]. Reasons for minority under-representation in RCTs are multifactorial and often involve system-level actors-e.g, clinicians, hospitals, and the community [21][22][23][24]. Historical acts of discrimination and marginalization in healthcare settings (e.g., the Tuskegee Syphilis Study) have been hypothesized as reasons why racial minorities are more distrustful of health systems and may also contribute to the under-representation of these groups in RCTs.…”

Cancer Health Literacy and Willingness to Participate in Cancer Research and Donate Bio-Specimens

“…Factors that affect individuals’ willingness to participate in cancer research include perceived benefits, barriers, and facilitators as well as sociodemographic characteristics such as age, race/ethnicity, education, and income [ 18 , 19 , 20 , 21 , 22 ]. Studies assessing the relationships between CHL and willingness to participate in research and donate bio-specimens are lacking among minority populations.…”

Best strategies to recruit and enroll elderly Blacks into clinical and biomedical research

“…One of the most important obstacles to clinical research is the difficulty in recruiting and retaining study participants of all ethnic backgrounds. 5 , 6 Historically, Blacks have been disproportionately underrepresented in clinical trials. 7 – 9 Although incremental progress has occurred since the establishment of the National Institutes of Health (NIH) Revitalization Act, barriers that influence participation of Blacks in research continue to exist.…”