Annual Report 2025 | Blue Star Investigator Program Expands Reach to Improve Clinical Trials

Launched in fall 2021, the original Blue Star Program is a 10-week blended learning experience that trains junior investigators in the practical skills of developing and running a clinical trial. Responding to the demands of busy clinical schedules, the program team revamped the original curriculum for fall 2025 and offered the Blue Star Investigator Accelerated Training Program.
Inspired by adaptations developed in collaboration with our partners at MaineHealth, the Accelerated program focuses on the skills needed to serve as a site-PI on an industry-sponsored clinical trial. Using the case study approach that is the hallmark of the Blue Star curriculum, learners follow the arc of a trial, from assessing feasibility, to site implementation, adverse event assessment, audit readiness, and study close-out. Eleven learners from Tufts Medical Center, Tufts University School of Medicine, and Lowell General Hospital completed the online didactic pre-work and participated in two full-day, hands-on, in-person learning sessions. All participants reported an increase in their overall confidence in running a clinical trial and in their proficiency across all 14 program competencies.
Additionally, in summer 2025 the team collaborated with Sharon Terry, MA, Director of the Recruitment and Retention Support Unit, to pilot a new five-week version, Blue Star BRIDGES (Building Research & Innovation for Drug Effectiveness & Safety). The Blue Star BRIDGES pilot brought together eight lay leaders from patient advocacy communities to explore the operational skills of developing and running clinical trials focused on repurposing drugs within the rare disease space.
One of the key elements across all versions of the Blue Star program is the mandatory live sessions, where learners apply the skills and knowledge gained in the online didactic content. These hands-on activities are consistently called out by participants in all programs as one of the most important elements to the Blue Star Program.
