Introduction: Most research on the barriers to recruitment of ethnic and racial minorities focuses on patient factors. The purpose of this exploratory case study was to examine how institutional factors impacted recruitment and enrollment in a public hospital clinic frequented by minority patients.
Methods: We used ethnographic methods (observations of patient-provider interactions and semi-structured interviews) to document and explain how a number of institutional barriers hindered trials enrollment in a public hospital outpatient breast cancer clinic.
Results: We identified two categories of institutional barriers: (1) organizational climate, and (2) research specific resources. Organizational climate included qualities of the clinic and hospital such as the clinic structure (clinic hours, patient assignment method), the interdisciplinary care team, the lack of continuity of care, and competing provider priorities of clinical care, teaching, and research. Research specific resources included: staff, funds and institutional status to facilitate opening a range of trials; and linguistically and literacy-appropriate research resources.
Conclusion: Although we cannot determine from our qualitative data the relative impact of different kinds of barriers (e.g. patient, provider, institutional barriers), our data highlights the need to address the role of institutional barriers in efforts to improve minority recruitment to clinical trials. Recruiting participants in safety-net settings may be a reasonable strategy for increasing accrual of ethnic and racial minority patients to cancer clinical trials. However, our qualitative data suggest that while opening protocols for accrual at minority-serving institutions may signal nominal access to trials, achieving substantive access may require further steps to overcome substantial institutional barriers.