Purpose. The National Institutes of Health have long challenged academia to improve clinical trial enrollment, especially in underrepresented populations; inclusive of geography, age, disability status, racial and ethnic minorities. It has been shown that rural and urban residents enrolled in clinical trials have similar outcomes, yet, rural healthcare systems struggle to provide opportunities to participate in clinical trials when infrastructure is limited or unsupportive of research programs and/or research staffing levels are insufficient. To fully address the barriers to clinical trial access in rural areas, it is not adequate to simply open more trials. Community receptivity of research as well as organizational and community capacity must be considered.
Methods. Herein we present the co-creation and implementation of a community-oriented approach to the receipt, review, and acceptance of clinical research in a rural community setting. We used an adapted 5 step Implementation Mapping approach to develop a systematic strategy intended to increase the success, and therefore, the number of clinical trials in a rural community.
Results. The review strategy, inclusive of a Regional Cultural Landscape and 3 co-created project submission and feasibility review forms, was pilot tested using a cancer early detection clinical trial that requires engagement from primary care and oncology and was shown to support strong researcher-community stakeholder communication, resulting in early identification and resolution of potential barriers and timely trial opening.
Conclusion. We propose that this approach may be replicated broadly as a key component of increasing clinical trial opportunities in rural and frontier settings.