Understanding organizational perspectives from clinical research stakeholders involved in recruitment for biopharmaceutical-sponsored clinical trials in the United States: Recommendations for organizational initiatives to improve access and inclusivity in clinical research

BACKGROUND: Equitable representation of racially and ethnically diverse subpopulations in clinical trials continues to be a problem, and trial participants do not always reflect the demographics of the population that the investigational product will be used to treat. The imperativeness of equitable representation of clinically relevant populations in clinical trials has implications for improving health outcomes, increasing knowledge about the safety and efficacy of new treatments across a wider population, and broadening access to innovative treatment options offered in clinical trials. METHODS: The purpose of this study was to understand organizational elements that are involved in the active implementation of racially and ethnically diverse inclusive recruitment practices for biopharmaceutical-funded trials in the United States. Semi-structured, in-depth interviews were used in this qualitative study. The interview guide was designed to explore the perceptions, practices and experiences of 15 clinical research site professionals related to recruiting diverse trial participants. Data analysis utilized an inductive coding process. RESULTS: Five themes were identified pertaining to the actual implementation of inclusive recruitment practices that provided explanations for organizational components: 1) provision of culturally appropriate, general disease and clinical trial education 2) organizational structure tailored for diverse recruitment 3) strong sense of mission related to improving healthcare through clinical research 4) culture of inclusion 5) inclusive recruitment practices evolving based on learning. CONCLUSION: The findings from this study offer insight into improving access to clinical trials by focusing on organizational change initiatives.