Impact of a Collaborative Clinical Trials Methodology Course on Trainees’ Funding and Clinical Trials Activity

Abstract

Introduction Clinical trials are challenging, and many junior investigators lack the skills to move through the phases in a coherent way. To address this issue in the clinical neurosciences, the NINDS Clinical Trials Methodology Course (CTMC) was created through cross university collaborations to provide junior investigators with relevant education and training to promote well-designed clinical trials. This study aims to explore the impact of CTMC by determining the trajectory of NIH funding and clinical trials activity in trainees after completion of the course. Methods The online databases NIH RePORTER and ClinicalTrials.gov were searched respectively to determine NIH funding and clinical trials activity of each CTMC trainee between 2014-2017. Data was collected on the Project Start Date of the first NIH grant and the Study Start Date of the first non-withdrawn clinical trial each trainee had after taking CTMC. Grants or trials prior to CTMC were noted. The date of a trainee’s CTMC was designated as January 1\n st of the year following course completion. Time until grant or clinical trial was calculated as the difference between the Project/Study Start Date and the trainee’s CTMC date. Results and Discussion There were 131 CTMC trainees between 2014-2017. As of early 2019, 23.7% of these trainees received a NIH grant and 43.5% became involved in a clinical trial after the course. Excluding those with prior experience, 11.5% of all trainees received their first-ever NIH grant and 27.5% became involved in their first-ever clinical trial following completion of CTMC. For all trainees who received a NIH grant or became involved in a clinical trial after the course, the median times to these achievements were 1.1 years (IQR 0.5-1.9 years) and 1.2 years (IQR 0.6-2.2 years), respectively. These results suggest that completing CTMC may help promote successful funding and clinical trials by junior investigators.