Professor of Pediatrics (Neonatology) Golisano Children's Hospital at The University of Rochester Medical Center Rochester, New York, United States
Background: Multicenter clinical trials advance our understanding of pathophysiology and evaluate potential advances in care. They are often complex, involving multiple services and time-limited study procedures. Although experienced clinical trialists may anticipate start-up challenges, unexpected issues may be detrimental to successful study completion. Simulation, utilized to identify latent safety events in patient care, could be used to identify study-related challenges and solutions for successful study implementation. Objective: To identify challenges during screening, enrollment, and implementation of study procedures for a clinical trial using team-based simulations. Design/Methods: A neonatologist, study coordinator and simulationist reviewed all aspects of the clinical trial, which randomized infants with seizures to receive study drug or placebo. They identified individuals from key stakeholder groups to participate in the simulations and developed 2 clinical scenarios that included various clinical and environmental conditions that would present different challenges. They conducted two 1-hr simulations followed by 1-hr debriefings. Debriefings were facilitated using a loosely structured debriefing guide. The authors engaged in a post-debriefing discussion to resolve identified challenges. Field notes were compiled from audio-recorded debriefings, which were coded and categorized into thematic categories. Results: Eleven individuals representing 6 stakeholder groups (clinical, encephalography, neurology, pharmacy and study teams) participated. Between the 2 scenarios, they raised 80 discrete questions, comments and items requiring clarification. Only 19% (6/31) of debriefing points overlapped between scenarios. The debriefing after the second simulation revealed 25 new questions, fewer than after the first scenario. Debriefing points were classified into 4 thematic categories with subthemes: communication among stakeholders, execution of study procedures, resources, and standard of care vs. study protocol (Table).
Conclusion(s): Simulation and debriefing may be utilized as a valuable tool to engage stakeholders in identifying potential barriers and complexities associated with clinical trials that are not apparent from reviewing the protocol prior to study initiation. Resolution of issues may improve enrollment rates and decrease the frequency of protocol deviations and violations.
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