Evaluating a community-focused approach to increase representation of understudied populations in clinical studies

Background: Our Community Scientist Advocate (CSA) program aimed to address the critical underrepresentation of ethnic minority populations in cancer-focused clinical trials by preparing health leaders to promote clinical research engagement in their communities. We developed and implemented an evidence-based training curriculum with six modules that discussed the role and benefit of clinical studies, research ethics, barriers to participation, social drivers of health, cancer care, and research engagement promotion strategies. Methods: CSAs are community health leaders and educators recruited via community health services or advocacy organizations. We delivered modules through Zoom and Teams with six CSA cohorts serving diverse communities in California. CSAs were encouraged to conduct community science and clinical study dissemination and log their activities. We assessed CSA preparedness to promote clinical research engagement through analysis of 12 items gathered in pre- and post-surveys. We evaluated the scope and reach of participants' community outreach activities, as well as barriers to study participation, through analysis of activity tracking forms and surveys. Results: A total of 103 participants, 83% female and 14% male, completed pre- and post-program surveys (n=103). Participants represented diverse communities, with 50% self-identifying as Latinx, 37% as Asian, 12% as African American/Black, and 2% as Pacific Islander. The mean score of participant preparedness increased from 24.7 at baseline to 31.3 post-intervention. 72 community outreach activities were reported through tracking forms and were estimated to serve more than 1662 community members. Activities consisted of 40 informal health research education and 32 formal health research education events such as community presentations, health fairs, etc. Participants noted that ongoing barriers to clinical study participation include concerns about research or health system trustworthiness; concerns about privacy or data use; language barriers; lack of information tailored to communities, cost barriers, lack of doctor referral, and embarrassment/cultural stigma. Conclusions: The CSA program offered an impactful approach to increase representation in clinical research through advocacy development. Further efforts are needed to continue building trust between clinical researchers and underrepresented communities, develop close partnerships between multisectoral stakeholders, and address structural barriers to research participation.