2025 Fall CTSA Program Annual Meeting

Tufts Clinical and Translational Science Institute launched the Blue Star Investigator Certificate Program in 2021, an education innovation designed to address a gap in hands-on training in the operational skills of developing and running investigator-initiated clinical trials. The first iteration of the program was designed as an 8-week blended learning experience, combining self-paced online didactic content with weekly 2-hour live sessions where participants engaged in active learning to apply concepts to real-world scenarios. After a successful initial cohort, [1] the program was expanded from 8 to 10 weeks in 2022 and 2023 to incorporate more opportunities for learners to develop their own clinical trial ideas in consultation with project mentors. Across all three cohorts, program participants consistently reported that the live in-person sessions were one of the most valuable aspects of the program. These sessions, however, are also resource- and labor-intensive and do not scale well. The challenge, then, was to develop a strategy to disseminate this training innovation to other audiences to expand reach and impact.

In collaboration with our partners at MaineHealth Institute for Research and the Northern New England Clinical and Translational Research Network (NNE-CTR) we developed a new variation of the program, Blue Star – Maine and an accompanying train-the-trainer model to adapt and scale the core curriculum to new audiences. In response to local needs, we adapted this program to focus on serving as a site Principal Investigator (PI) for industry clinical trials and shortened the in-person sessions to 1 ½ days. In 2025 we developed and offered a third variation of the core Blue Star curriculum, this time tailored to the needs of lay leaders in patient advocacy groups – an underserved audience with an identified need for education in clinical trial operations.

This poster illustrates how Tufts CTSI is adapting the Blue Star program to meet the needs of different learner groups and scaling our training innovation to other sites while retaining the key components that contribute to high-impact learning.

1. Markman KM, Brewer SK, Klein AK, Magnuson B. Developing an engaging and accessible clinical research training program for new investigators. Journal of Clinical and Translational Science. 2023;7(1):e53. doi:10.1017/cts.2022.446