Organizational Determinants of Minority Participation in Clinical Research

Poor rates of minority participation in cancer clinical trials, and inequitable distribution of results from clinical research contribute to persistent disparities in cancer care outcomes. Systematic reviews of minority participation in clinical research reveal extensive research on patient and provider-level barriers to participation in clinical trials; however, there is limited research on the organizational drivers of minority enrollment in clinical treatment trials. The goal of this dissertation is to enhance our understanding of the organizational determinants of minority participation in cancer treatment trials. The objectives of this dissertation are: (1) estimate the impact of organizational characteristics associated with black enrollment in National Cancer Institute (NCI) sponsored clinical treatment trials offered by organizations participating in the NCI Community Clinical Oncology Program; (2) examine the strategies of organizations participating in the NCI Community Clinical Oncology Program resulting in high enrollment of minorities in National Cancer Institute (NCI) sponsored clinical treatment trials; and (3) evaluate disparities in geographic access to organizations offering National Cancer Institute (NCI) sponsored clinical treatment trials for minority populations in the continental United States. The first study employs a multivariate, longitudinal regression approach to empirically estimate the impact of organizational characteristics on enrollment of blacks in clinical treatment trials. Results demonstrate that few modifiable organizational characteristics are associated with enrollment of blacks in treatment trials. However, it appears that organizations that do and do not serve large minority populations with culturally competent services can implement policies and practices that enhance black participation in clinical research. The second study employed a fuzzy-set qualitative comparative analysis in order to investigate organizational strategies, comprised of tactics, which achieve high enrollment of minorities in clinical treatment trials as defined by NCI officials. In the study, tactics represent organizational design features. For example, a clinical trial organization may choose to have or not have annual training events. Results indicate that there are 4 strategies that consistently achieve high enrollment of minorities in treatment trials, and also demonstrates strategies employed by clinical trial organizations (CTOs) that do not serve large minority populations can implement policies and procedures that achieve high enrollment of minorities. Finally, a network analysis approach was employed using ZIP code tabulation area (ZCTA) data, and geocoded locations of organizations offering NCI-sponsored clinical trials in order to investigate disparities in geographic access to CTOs. Results from the three studies have theoretical, practical, and policy implications. This dissertation provides empirical support for Ford and colleagues conceptual framework describing barriers and facilitators to underrepresented populations' participation in clinical trials. CTO leaders can use findings from this dissertation to enhance their strategies to enroll minority patients in clinical treatment trials. Additionally, whereas our results demonstrate that overall geographic access to CTOs is excellent, policymakers can use the findings from the network analysis in order to address disparities in geographic access to CTOs for racial and ethnic groups residing far from CTOs.Doctor of Philosoph