Objectives/Goals: To describe the pathway of support trial-care has put into place for washu and partner ctsa researchers navigating the investigator-initiated clinical trial life cycle. Methods/Study Population: Trial-care is a centralized research support service at washu supported by the center for clinical studies (ccs) and the institute of clinical and translational sciences (icts). our team consists of experienced investigators and research professionals with expertise in clinical trial management across all phases of the trial life cycle. for washu and partner ctsa researchers planning investigator-initiated clinical trials, we provide a free 60-minute consultation to analyze barriers and streamline processes. after the initial consultation, researchers may receive trial-care services (e.g., project management, quality and regulatory management, and/or data management). these services can be billed at an hourly rate or through direct sourcing of trial-care staff to the funded grant. Results/Anticipated Results: Trial-CARE’s support for investigator-initiated clinical trials accelerates all phases of the trial life cycle, such as pre-award planning and post-award start-up, implementation, and closeout. Since 2019, Trial-CARE has completed over 142 consultations across 20 Departments at WashU, SLU, and Mizzou. At the time of consult, 54.4% were in the pre-award planning phase and 45.6% were in the post-award start-up, implementation, or closeout phase. About 20% of consultations lead to the utility of Trial-CARE Services, and the top reasons researchers connect for consultation to receive Trial-CARE Services: (1) regulatory guidance (FDA Part 11, IND, IDE, IRB) = 55% (2) safety monitoring or site/data monitoring = 33% (3) data management = 23% (4) study budgeting = 19% (5) protocol development = 17%. Discussion/Significance of Impact: Trial-care uses a clinical trial dashboard to identify and track pre-award investigator-initiated clinical trials and is developing outreach and training programs to pro-actively engage these studies. the goal is to maximize clinical trial impact through quality (rigor and best practices), innovative capacity, and reproducibility.
Keenoy et al. (Wed,) studied this question.