Barriers and Facilitators for Equitable Clinical Research Among Pragmatic Trialists: A Qualitative Study

Purpose: There is a growing urgency to address health inequities in clinical trial design. Pragmatic trials hold promise in addressing inequities in research. We conducted a rapid qualitative analysis of barriers and facilitators to implementing health equity practices in pragmatic trials within the NIH Pragmatic Trials Collaboratory, informed by the DUSON-INFUSE checklist. Participants and Methods: A descriptive qualitative design was used to address barriers and facilitators to equitable pragmatic trials. Twelve semi-structured interviews with primary investigators and research associates were conducted. Included trials were selected to represent a variety of phases of funding and study progress to examine the full lifecycle of research. Interview transcripts were summarized using a standardized matrix. Rapid qualitative analysis was implemented to condense data into four emergent themes. Results: Trialists were in the enrollment (n=8), follow-up (n=1), and completion (n=3) phases of their research. Study themes described how (1) funding timelines dictate community relationship building, (2) concordant identities between research teams and study populations promote equity, (3) community alignment on priorities facilitates success, and (4) intervention flexibility is necessary to support participant engagement. Conclusion: To optimize the potential for pragmatic clinical trials to reduce health inequities, all phases of research must be designed with health equity in mind. This includes funding timelines and research budget planning that leave space for relationship building, as well as co-developed priorities between investigators and communities to ensure research fosters trust and engagement. Keywords: health services accessibility, clinical trials, study design, qualitative research