Work

Validation of research site mentorship as an approach for increasing study site performance (enrollment)

Year: 2026

Type: article

Abstract: The identification of strategies that improve participant enrollment in clinical trials remains a key focus of stakeholders in this field, due to its role as a leading indicator of timely trial completion and its contributions to the validity and generalizability of clinical trial results. The VA Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) replicated a previously piloted research site mentorship model in two actively enrolling CSP-funded clinical trials to validate its impact on study participant enrollment (CSP #2005: VA Lung Cancer Surgery vs. Stereotactic Radiotherapy trial (VALOR) and CSP #2008: Pentoxifylline in Diabetic Kidney Disease (VA PTXRx)). The “Total Randomized Participants (#) by Mentee Site” and the “Percentage of Randomized Participants (Actual/Expected) Monthly Average By Site (%)” were evaluated across participating mentee study sites over three time periods: 1) 5-month pre-intervention period (PIP), 2) 5-month intervention period (IP), and 3) 3-month follow-up period (FUP). These data were averaged across months during the respective time periods (PIP, IP, FUP). Our findings demonstrate an association between the NODES site mentorship model and improvements in most mentee sites’ “Total Randomized Participants (#) ” (4/7; 57%) at the end of the 5-month intervention period (IP), as compared to the 5-month pre-intervention period (PIP) (Table B). Increases in most sites’ (5/7; 71%) “Percentage of Randomized Participants (Actual/Expected) Monthly (Average) By Site (%)” at the end of the 5-month intervention period (IP), as compared to the 5-month pre-intervention period (PIP) was also observed (Table C).

Source: Contemporary Clinical Trials Communications

DOI: 10.1016/j.conctc.2026.101703