Primary Author: Veronica Ajewole-Mwema, PharmD, BCOP, Texas Southern University

All Authors: 1. Randall J Urban, MD: University of Texas Medical Branch Galveston 2. Liz Hennessy MSN, RN, CCRP: University of Texas Medical Branch Galveston 3. Lori Simon, RN, BSN, CCRP: University of Texas Medical Branch Galveston 4. Ivy Poon, PharmD, BCPS: Texas Southern University 5. Elizabeth Ofili, M.D., M.P.H., FACC : PhRMA Foundation EQBMED (Morehouse School of Medicine), RCMI Coordinating Center, Clinical Trials Access Collaborative 6. Tesheia Howard Harris MBA, MHS: PhRMA Foundation EQBMED (Yale School of Medicine), Clinical Trials Access Collaborative 7. Edith Declan, BSc Ed., BSN-RN, MSN, APRN, FNP-C.: Texas Southern University 8. Tandeca King Gordon, Ed.D., MEd: PhRMA Foundation EQBMED (Morehouse School of Medicine), RCMI Coordinating Center 9. Nkechi Ogboh, PharmD, MPH, CPH: Texas Southern University 10. Esther A Olaleye, PhD, MPH: Texas Southern University

Lay Summary: Texas Southern University (TSU), a low-resourced HBCU and an Higher Education Institution created a new, community-focused clinical research site to help more community members—especially those with unmet health needs—learn about and join clinical studies. With mentorship by the University of Texas Medical Branch Galveston, PhRMA Foundation EQBMED, and RCMI Coordinating Center, TSU hired, trained and certified staff, engaged community members, leaders and advisors, and set up the needed systems (regulatory processes, data management, IRB, budgeting, and standard procedures). The site successfully launched a clinical research participant registry and began collaborations with research sponsors and community groups. While TSU faced challenges starting this first of its kind infrastructure, the successful effort shows how universities can expand access to clinical research through strong teamwork and community partnership.

Objectives/Goals: Texas Southern University (TSU), a low-resourced HBCU and one of the largest in the US, without an affiliated hospital, clinic network, or patient population, established a community-focused clinical research site to educate, recruit, and expand research participation, especially among those with unmet health needs.

Methods/Study Population: The implementation process involved strategic planning in five key areas as below: * Collaboration:Partnered with mentor site to align site capabilities with industry standards * Capacity Building:EstablishCTMS, eReg, eSource, and REDCap workflow * Workforce Training: Hired and strengthened research personnel expertise through training, certification, and mentorship * Community Engagement: Enhanced trusted relationships with community members, key stakeholders, and advisory board members * Infrastructure Development: Defined site capabilities: regulatory processes, data management, IRB optimization, budgeting, contract management, and prospective study feasibility assessments. Developed standard operating procedures and clinical research registry for site readiness

Results/Anticipated Results: A first of its kind Community-Focused Clinical Research Site in a low-resourced HBCU without an affiliated hospital, clinic network, or patient population was successfully established at TSU with mentorship by the University of Texas Medical Branch Galveston, PhRMA Foundation EQBMED, and RCMI Coordinating Center. A registry for potential research participants was successfully implemented in May 2025. Since its inception, 160 community members have indicated interest in clinical research registry participation. 56 community members are fully enrolled in the registry. Key challenges included bridging feasibility gaps at TSU, navigating the development of new clinical research infrastructure, and managing regulatory and contracting approval timeline.

Discussion/Significance of Impact: Establishing a clinical research site in a low-resourced HBCU without an affiliated hospital requires cross-disciplinary collaboration and intentional community engagement. TSU’s approach offers a replicable model for integrating clinical research to expand access to community member especially among those with unmet health needs.