Improving treatment of neurological diseases requires clinical research, but a barrier is a shortage of capable, well-trained clinician-scientists. The Clinical Trials Methodology Course (CTMC) was conducted from 2014-2023 to educate clinician scientists in the neurosciences in the design of clinical trials. The CTMC was designed with the goals of academic retention, enhancing research productivity, providing mentorship, and improving the likelihood of successful grant applications. 

We describe the structure and outcomes of the CTMC. Data were from surveys, PubMed.org, and NIH Reporter.

CTMC had competitive application of trainees. The course created small groups, consisting of 2 faculty advisors, one faculty biostatistician, and 2-4 trainees who met remotely approximately weekly over 12 weeks. Online webinars reinforced small group topics. Faculty and trainees then met for a 4-day in person residential course. Follow-up activities included 2-3 follow-up remote meetings and a mock study section review of draft grants applications.

CTMC enrolled 243 trainees (mostly asst. professors) from 2014-2023. 96% remained in academia. Trainees published 7666 peer-reviewed articles from their enrollment year to 2023 (mean 31.5 articles per trainee, or mean±SD of 5.0±5.1 per year per trainee). There were 7120 unique articles; trainees were mutual co-authors in 546. Of 173 surveyed trainees, 109 (63%) submitted an NIH grant as PI or co-PI, and 68 (62% of 109) were funded within a median of 3 years after course completion. Of the 243 total trainees, 91 (38%) were principal investigators for at least one NIH grant since their course participation to 2023. Trainees served as medical monitors, on Data and Safety Monitoring Boards, investigators for NIH research networks, and faculty in the CTMC itself.

CTMC provided a robust foundation in trial methodology to a generation of clinician-scientists. A new CTMC will enroll trainees in Spring 2025 with annual reunions and presentations with support from the AAN.