PROGRESS: Implementation of a novel hybrid decentralized clinical trial to support precision oncology uptake at academic and community oncology practices in North Carolina.

Abstract

e23150 Background: Rates of comprehensive molecular profiling (CMP), use of evidence-based genome-informed therapy (GIT), and clinical trial participation remain low in real-world data sets. We designed an interventional clinical trial (PROGRESS) using decentralized methodology to evaluate the impact of a centralized precision oncology navigator and pharmacist-led expert CMP review on GIT order rates and cancer outcomes in an academic practice and a network of community practice locations (CPLs) in North Carolina. We leveraged academic medical center (AMC) experience in hybrid decentralized clinical trials (hDCTs) to design a more accessible, community-friendly trial. Herein we describe the operational challenges and solutions. Methods: The PROGRESS study was operationalized as an hDCT in which local providers at CPLs were not engaged in research per the regulatory definition as they performed only assessments consistent with standard of care. Regulatory oversight was maintained by the AMC. A pre-launch meeting assessed CPL interest and feedback on study integration into clinical workflow. Launch meetings were then led by the AMC including PIs, study coordinator (SC), and regulatory staff. The AMC-based SC identified potential subjects via the shared electronic health record (EHR) and obtained electronic consent remotely; all follow up assessments were done via medical record abstraction. Descriptive qualitative and process-level metrics were used to identify challenges and guide workflow adaptations. Results: In addition to the AMC, three of four CPLs approached were onboarded with n = 40 subjects enrolled over 6 months. One CPL declined due to lack of provider time. Key onboarding facilitators included: a local study champion, integrating study requirements into clinical workflows, and addressing remote consent concerns. Post-launch enrollment barriers included: lack of multidisciplinary collaborators, participant language barriers, poor health literacy, research-fatigue (primarily at the AMC), and inefficient pre-screening tools. Adaptations to these barriers included a monthly enrollment newsletter, a protocol amendment to accommodate CMP order workflows, removal of burdensome surveys, translation of consent forms, and an efficient pre-screening report leveraging EHR-integrated CMP orders. Following these changes, enrollment increased by 50% in the second versus the first quarter. Conclusions: The implementation of PROGRESS using hDCT methodology generated practical insights to strengthen partnerships with CPLs, informing scalable approaches to expand access to precision oncology support and local clinical research opportunities. Clinical trial information: NCT06896162 .