Abstract: Enhancing Minority Participation in Clinical Trials: A Region-Based, National Approach to Overcoming Minority Participation Barriers to Clinical Trials
Health disparities are particularly significant across the cancer continuum. The burden of cancer in racial and ethnic minorities is great. The most recent cancer statistics from the American Cancer Society, confirm that minority populations continue to have poor chances of survival once cancer is diagnosed, suggesting possible influence of disparities in access to and receipt of quality health care. In lieu of a full understanding of the etiology of the disparities, efforts can be directed to provide opportunities for participation in state-of-the art cancer therapies for those diagnosed with cancer. Because access to the cutting-edge medical treatments and state-of-the-art care that clinical trials provide is not equally available to people in minority communities, this inequity in participation contributes to the ongoing health disparities. It is clear that successful recruitment of minority participants to clinical trials needs to begin with efforts to develop trusting relationships between the minority community and the research institution. Mounting evidence also suggests that efforts to recruit minorities are more labor intensive and need to involve more personal contacts. These findings speak to the importance of developing culturally appropriate recruitment strategies. A review of the literature suggests that minorities are just as willing to be involved in research studies as the general population. Therefore, structures need to be in place to help minorities overcome barriers to participation and improve their representation in clinical trials.
To address these issues, the EMPaCT Consortium was established in 2009 and includes five regional EMPaCT Cancer Centers: 1) University of Minnesota (Midwest); 2) University of Alabama at Birmingham (Southeast); 3) Johns Hopkins University (East); 4) University of Texas MD Anderson (South); 5) University of California, Davis (West). Qualitative and quantitative research done at each of the regional sites identified patient, institutional and system level barriers, as well as facilitators to clinical trial enrollment. Based on these findings, the EMPaCT The Consortium is currently developing and implementing a comprehensive effort to enhance clinical trials recruitment and retention in the United States by utilizing two strategies to enhance minority accrual in cancer trials: a) education and training approach, implemented through Web-based modules; and b) intervention approach, which will establish a patient navigation and clinical trial support system including cancer center ombudsmen. The EMPaCT consortium will also develop and pilot additional innovative recruitment and retention models. Each of these approaches will be empirically tested at each of the regional sites with the primary outcome of a 5% increase in minority enrollment into therapeutic cancer clinical trials.