Developing InnoVative Equity-focused Regulatory SciencE (DIVERSE)

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Project Summary/Abstract Advancing health equity through diversity in clinical trials and other regulatory science research can be achieved with diverse community-based recruitment sites when amplified with innovative application of the science of engagement and appropriate community infrastructure. This proposal builds on The University of Maryland Baltimore (UMB) PATIENTS Program’s decade of advancing health equity research and the science of engagement in collaboration with established community-based organization (CBO) partnerships with (1) Walgreens, the nation’s second largest network of community pharmacies and (2) Mt. Lebanon Baptist Church (MLBC), an African American church that has been a longstanding partner of the PATIENTS Program. Dr. Mullins and the PATIENTS Program have advanced the science of engagement, which builds upon fundamental concepts of team science but expands the “team” to include non-traditional researchers, such as patients, community-based providers, community health advocates, learning health system administrators, and other stakeholders in scientific investigations. Including and engaging a more diverse team of stakeholders is proposed as a means to incorporate multistakeholder perspectives that collaboratively and synergistically can advance health equity. Before full scale implementation of diversity initiatives using CBOs, it is important to produce a “proof of concept” to demonstrate the feasibility of CBOs to effectively identify, recruit, refer, retain, and continuously engage patients and relevant stakeholders throughout the clinical trial. Our proof of concept is achieved through simulation exercises of clinical trial and other health equity regulatory science studies in CBO locations. The proposed simulation exercises align with Dr. Mullins’ evidence based 10-Step Framework for Continuous Patient and Stakeholder Engagement. Our simulation exercises are designed to assess whether and how to partner with CBOs to achieve health equity to enhance diversity in clinical trials and other regulatory science research. To achieve that overarching goal, we propose three Aims as follows: Aim 1: Collaboratively prioritize health equity simulation scenarios to address health equity-related barriers and facilitators for underrepresented populations’ enrollment in clinical trials and other regulatory science research in partnership with 2 CBOs: community pharmacies and faith-based organizations; Aim 2: Conduct and evaluate health equity simulation of enrollment in clinical trials and other health equity regulatory science research to test feasibility of workflow in CBO settings as enrollment, retention, and dissemination sites for clinical trials and other regulatory science research; Aim 3: Evaluate and prioritize action-oriented health equity activities to enhance CBO capacity to address health equity-related barriers and facilitators and increase enrollment in clinical trials and other regulatory science research by underrepresented populations.