ASPO Abstracts
New community research review system tests feasibility of subsites to boost diverse recruitment to early detection trials
Category: Early Detection & Risk Prediction
Conference Year: 2023
Abstract Body:
Purpose: Only 2% of the ten thousand NCI-supported clinical trials have sufficient diversity. Challenges to achieving diversity for Early Detection trials are different than for treatment trials. Typically, they are not offered in clinical settings, require enrollment of healthy individuals from the general public and in large numbers. Method: Collaboration on two consecutive trials with the same sponsor served to test a new process to increase diversity in enrollment at OHSU Knight Cancer Institute's Early Detection Program (CEDAR). Both studies evaluated a multi-cancer early detection (MCED) test with a blood draw and return of results to participants. Trial1 was run entirely at OHSU and while we exceeded enrollment goals, our cohort was not diverse. Prior to Trial2, our team, in collaboration with longstanding community partners, used novel tools to assess feasibility of running subsites for enrollment. Deployed early in the trial planning phase, the Research in Oregon Communities Review (ROCR) system allows the community to determine Go/NoGo, identify obstacles, and gives opportunity for culturally appropriate adjustments to recruitment and implementation. Importantly, this bi-directional negotiation results in tangible investment from key collaborators. Results: In Trial2 we are partnering with 4 remote health systems serving diverse communities. From ROCR we learned that local enthusiasm was great, but resources, personnel and experience with large trials were roadblocks. Through collaborative problem-solving with the community prior to trial initiation, we implemented tailored adaptations and gained community buy-in. These efforts have resulted in dramatic success: increasing our racial diversity 4-fold, ethnicity 15-fold, and doubling rural representation. As evidence of sustained relationship and trust building, new trials are launched and cancer prevention education is expanding in these subsite communities. Conclusion: Engaging the community early and collaboratively comes with challenges; be prepared to overcome hurdles, spend extra time and money to achieve partnerships that will be sustainable into the future. Early Detection trials are not a passing fad and relying on established relationships will be critical to building representative cohorts.
Keywords: community engagement, relationship building, MCED, trials, enrollment