National Institute of Neurological Disorders and Stroke Clinical Trials Methodology Course: Summary and Accomplishments 2014-2023.

Abstract

The Clinical Trials Methodology Course (CTMC), given from 2014 to 2023, was conducted to educate early-career clinical investigators from various backgrounds in neurosciences in the design of clinical trials and to provide mentorship to enhance academic careers and retention plus improve research productivity and the likelihood of successful grant applications. This summary describes the rationale, history, structure, and trainee outcomes of the CTMC. The course used small groups, consisting of 1-2 clinical faculty advisor(s), 1 faculty biostatistician, and 2-4 trainees who met remotely approximately weekly over 12 weeks. 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 grant applications. The CTMC enrolled 243 trainees from 2014 to 2023 (excluding 2020) into Foundation (173) or other (70) tracks. Ninety-six percent of trainees remained in academic positions. Trainees published 7,666 peer-reviewed articles from their enrollment year to 2023 (mean 31.5 articles per trainee, or mean ± SD of 5.0 ± 5.1 articles per year per trainee). There were 7,120 unique articles; trainees were coauthors in 546. Of 173 Foundation Track trainees, 109 (63%) submitted an NIH grant as principal investigator or co-principal investigator, and 68 (62% of 109 submitters) were funded within a median of 3 years after course completion. Of the 243 total trainees, 91 (38%) were principal investigators for at least 1 NIH grant since their course participation to 2023. Trainees have participated as medical monitors, members of data and safety monitoring boards, investigators for NIH research networks, and faculty in the CTMC itself. CTMC has provided a robust foundation in clinical trial methodology in neuroscience research to a generation of clinical investigators.