Trajectory of NIH Funding and Clinical Trials Activity in Trainees of a Clinical Trials Methodology Course

Abstract

Introduction: While clinical trials are necessary for determining new treatments, many trials fail to advance through the different phases due to the complexity and cost of the process. To address this, the NINDS Clinical Trials Methodology Course (CTMC) was created to identify promising investigators in clinical neurosciences and provide them with specific training to lead successful trials. The course has been run for multiple years and includes webinars, in-person conferences, and small group experiences that provide education in designing, conducting, and reporting clinical research. It is hypothesized that the CTMC will help investigators receive NIH grants and become involved in National Clinical Trials (NCTs) after completion of the course.

Methods: There is a readily available list of CTMC alumni from 2008-2017. Their names were input into the NIH Research Portfolio Online Reporting Tools (RePORT) and data was collected regarding if they had a NIH grant prior to taking the course and if they received a new NIH grant after the course, and if so, the new grant’s Project Number and Project Start Date. Similar steps were taken on ClinicalTrials.gov for NCTs, including collection of new NCT’s Identifier and Study Start Date. Withdrawn NCTs were excluded. The names used in the search were combinations of first name, last name, middle name, and middle initial, and results were cross-matched with the institutions each investigator has been associated with. The date of a participant’s CTMC was designated as January 1st of the year following their completion of the course. Data was collected with Google Forms and quantitative analysis was done in Microsoft Excel.

Results: There were 307 clinical investigators who participated in the CTMC between 2008-2017. From this group, 31.9% (N=98) received a new NIH grant after the course, and 51.1% (N=157) became involved in a new NCT after the course. Of those who received a NIH grant after the CTMC, 45.9% (N=45) had never had a NIH grant before. In other words, 19.7% (N=45) of the participants without a NIH grant prior to the course received one after taking the CTMC. Of those who became involved in a NCT after the CTMC, 67.5% (N=106) had never been involved in a NCT before. Similarly, 47.5% (N=106) of the participants without prior involvement in a NCT became involved after taking the CTMC. For all participants, the average time between taking the course and receiving a new NIH grant was 2.2 years (N=97, SD 1.8 years), and the average time until involvement in a NCT was 2.8 years (N=157, SD 2.5 years).

Conclusion: Many investigators obtained new NIH grants and became involved in new NCTs after completion of the CTMC course.