Embedding community voices in clinical research: The value of community scientists in IIT protocol review

Introduction: Investigator-Initiated Trials (IITs) advance scientific discovery, test interventions, and address unmet clinical needs; however, traditional research processes often overlook the perspectives of communities most affected by cancer disparities, leading to protocols that unintentionally reinforce barriers to participation among underrepresented groups. Community Scientists , comprising patients, caregivers, health professionals, and community leaders, offer lived expertise to ensure that study materials, eligibility criteria, and recruitment strategies reflect the realities of the populations affected by cancer. Methods: Cedars-Sinai Cancer Center Community Outreach & Engagement (COE) identified and trained 11 lay community members as Community Scientists, equipping them with foundational knowledge in clinical trial design, ethical and informed consent considerations, and practical approaches to mitigating participation barriers. COE facilitated engagement between clinical researchers and Community Scientists by integrating them into the IIT protocol review process, resulting in 18 IITs and 243 PRMC reviewed in the past 3 years. To assess the integration and impact of Community Scientist recommendations, COE surveyed 14 clinical researchers (11 initiated, 5 fully completed). Recommendations focused on gender-neutral language, language accessibility, financial toxicity, transportation support, food insecurity, navigation and referral pathways, and health literacy. Results: Clinical researchers rated COE and Community Scientists as effective or very effective (80%, n=5) in providing valuable recommendations on IIT protocols, resulting in increased participation and retention of underrepresented communities in clinical trials (1-2 patient referrals yearly from COE). Qualitative feedback from clinical researchers highlighted meaningful practice changes, highlighting that Community Scientists' recommendations were either already adopted or being considered for future studies: “We adjusted our discussion with patients to improve engagement and retention in trials”. Adoption was highest for recommendations related to interpretation and translation services, parking voucher availability, financial and social support navigation, and warm handoffs to internal and external community partners (60%, n=5, respectively). Conclusion: Clinical researchers recognized the value of collaboration with COE and Community Scientists, and expressed a strong interest in expanding Community Scientists' involvement in early-stage study design, translational and therapeutic science, protocol development, dissemination of findings, and participation in educational activities. The contributions meaningfully enhance the cultural relevance, feasibility, and inclusivity of investigator-initiated trials.