Enhancing Diversity in Clinical Trial Enrollment through the DIVERSE Community-Based Protocol Review Process

What this Trial Is About

This research focuses on improving inclusion and diversity in clinical trial enrollment by piloting a community-based protocol review process called DIVERSE. The study evaluates the feasibility, acceptability, and initial effectiveness of this approach, which involves training participants to provide feedback on clinical trial protocols in development. It is based on a community-based participatory research model and is supported by the National Cancer Institute and American Society of Clinical Oncology. Participants include both patients and community members as well as investigators. Enrolled participants complete confidentiality agreements, demographic questionnaires, specialized online and in-person or remote training, and provide timely protocol reviews. They also participate in audio recorded meetings and exit interviews or focus groups to give feedback on the process. Investigator participants request reviews, complete surveys, and provide feedback on the DIVERSE process. Participation lasts about 18 months and involves completing questionnaires, training sessions, protocol reviews, meetings, and interviews. Researchers measure outcomes such as the rate of protocol review completion, timeliness of reviews, and acceptability scores of the intervention over the study period. The study collects feedback to assess and improve the protocol review process aimed at enhancing trial diversity and inclusion.

Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)