Impacts of Clinical Trial Didactic Curriculum for Vascular Neurology Fellows
Karen Shabano Stalin Durairaj1, Abbey Staugaitis1, Christopher Streib2
1University of Minnesota, 2Department of Neurology
Objective:
To study the impact of a formal clinical trial didactic curriculum on stroke fellows.
Background:
A key barrier to stroke clinical trial recruitment is the lack of experienced investigators at the site level. However, there are currently no standards for training Vascular Neurology Fellows in clinical trial recruitment.
Design/Methods:
Our fellowship initiated a formal clinical trial curriculum for Vascular Neurology fellows in 2016. The curriculum began with dedicated trial protocol training and expanded yearly to include: didactic lectures on clinical equipoise and clinical trials, mock informed consent practice, eConsent training, research operations meetings, shadowing faculty consents, and 1:1 study onboarding. We reviewed all clinical trial enrollments from 2015-2022 and determined the number completed by stroke faculty, fellows, or other. The proportion of fellow enrollments was analyzed using the Mann-Kendall test. We surveyed previous fellows regarding the curriculum and determined whether they were currently participating in clinical trials.
Results:
Our analysis found that fellow enrollment and total enrollments progressively increased by academic year as the training curriculum was implemented. The Mann-Kendall test demonstrated a trend for an increasing proportion of fellow enrollments during the study period (p=0.08). Fifteen of sixteen (93.7%) graduated fellows completed the survey; seven (46.6%) are currently enrolling in clinical trials–four of whom (57.1%) enrolled ≥3 subjects during fellowship; thirteen (86.6%) intend to enroll in stroke clinical trials in the future. The majority of graduated fellows stated that the most valuable aspect of their clinical trial curriculum was learning how to conduct informed consent and complete an enrollment.
Conclusions:
We found that total clinical trial enrollments and trial enrollments completed by Vascular Neurology fellows increased with the intensity of the clinical trial didactic curriculum. Active recruitment during fellowship was suggestive of ongoing participation in stroke clinical trials post-fellowship.