Abstract
Objective: The presentation aims to demonstrate the utilization of an innovative trial design, incorporating a smaller trial within a larger trial to assess the effects of supplemental, reinforced, risk-based training.
Background: Historically there is a lack of research on clinical trial operations. Our approach is rooted in addressing this gap, by exploring the impact of supplemental, reinforced risk-based trainings on clinical site preparedness within the context of a large-scale PRECISE trial.
Methods: We leveraged the existing infrastructure of the large-scale multi-center PRECISE trial and implemented a trial within the trial design, randomly assigning 12 sites to receive supplemental Training and the remaining 12 to follow standard training protocols. The REDCap survey served as the platform for Training implementation.
Results: Findings showed a trend in immediate increases in approach rates following training (p-value 0.074) but it did not reach statistical significance compared to their counterparts.
Conclusion: The insights gained from this trial underscore the need in studying the clinical trial operations themselves. To strengthen the credibility the innovative trial-within-a-trial model, it is recommended to replicate similar trials within larger RCTs over 12-month period. The positive findings encourage further exploration and validation of the risk-based training approach as a valuable tool for optimizing site performance.
References
- Bechtel, J., et al., Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates. Contemp Clin Trials, 2020. 89: p. 105918.
- Arango, J., et al., Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency. Ther Innov Regul Sci, 2016. 50(4): p. 480-486.
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Enhancing Clinical Site Preparedness in Pediatric Sepsis-Induced MODS: A Trial Within the Trial Approach by Valeriya Vasenina, MS & John VanBuren, PhD