A study within a trial evaluating supplemental, reinforced risk-based training to reduce implementation barriers in a...

High-quality conduct of clinical trials depends on strict adherence to both regulatory protocols and trial-specific procedures to ensure data integrity and participant safety. Standard methods utilized to train research staff have limitations, including lack of specificity and declining impact over time. We developed a Supplemental, Reinforced, Risk-Based Training (SRRBT) program, designed to target study-specific challenges and provide ongoing reinforcement. Our objective was to evaluate whether SRRBT improves protocol adherence.

SRRBT was executed as a cluster-randomized, educational implementation study embedded in a multicenter clinical trial. We compared standard training with and without the addition of SRRBT across 23 clinical sites. SRRBT consisted of five interactive electronic vignettes focusing on trial-specific competencies. The primary outcome was the proportion of eligible participants approached for study participation. Secondary outcomes included consent and enrollment rates, protocol deviations, and completeness of study documentation.

Approach rates immediately following training trended higher at SRRBT sites compared to those receiving standard training alone (OR = 3.98, 95% CI [0.87, 18.17], p = 0.074); however, this difference was not statistically significant and attenuated over time, with odds ratios of 2.24 (95% CI [0.78, 6.49], p = 0.14) at six months and 1.38 (95% CI [0.53, 3.59], p = 0.51) at 12 months post-training.

SRRBT shows potential in enhancing early site-level protocol adherence but may require ongoing reinforcement to sustain benefits over time. This study highlights the need for continuous, adaptive training approaches in complex clinical trials to maintain high standards of protocol adherence.