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

Area of Science:

• Clinical Trials
• Medical Education
• Research Integrity

Background:

• Standard clinical trial staff training methods have limitations in specificity and long-term impact.
• Ensuring data integrity and participant safety necessitates strict adherence to protocols.
• A Supplemental, Reinforced, Risk-Based Training (SRRBT) program was developed to address study-specific challenges and provide continuous reinforcement.

Purpose of the Study:

• To evaluate the effectiveness of the SRRBT program in improving protocol adherence among clinical trial sites.
• To assess whether SRRBT enhances the proportion of eligible participants approached for study participation.

Main Methods:

• A cluster-randomized educational implementation study embedded in a multicenter clinical trial.
• Comparison of standard training versus standard training plus SRRBT across 23 clinical sites.
• SRRBT utilized five interactive electronic vignettes focusing on trial-specific competencies; primary outcome was participant approach rates.

Main Results:

• Sites using SRRBT showed a trend towards higher participant approach rates immediately post-training (OR=3.98), though not statistically significant.
• This initial trend attenuated over time, with non-significant odds ratios of 2.24 at six months and 1.38 at 12 months.
• Secondary outcomes like consent, enrollment, deviations, and documentation completeness were also assessed.

Conclusions:

• SRRBT demonstrates potential for improving early site-level protocol adherence in clinical trials.
• Sustaining the benefits of SRRBT may necessitate ongoing reinforcement strategies.
• The study underscores the need for continuous, adaptive training approaches in complex clinical trials.