I read with great interest the recent article by Dadiz et al., “Simulation as a Potential Tool for Successful Clinical Trial Initiation” [Reference Dadiz, Jones and Guillet1], which describes the use of simulation to identify latent barriers in trial start-up and optimize team-based implementation. The authors are to be commended for advancing this important conversation and documenting a process that will likely improve trial readiness across many domains.
In reviewing their work, I noted a close parallel to a body of research my team and I published between 2004 and 2010, in which we developed and evaluated the use of high-fidelity simulation not only for training research coordinators, but also as a systems-level tool to refine clinical trial protocols, clarify team roles, and proactively mitigate latent safety threats before real-patient enrollment.
Our early work – conducted in collaboration with the Duke Clinical Research Institute and Dr Robert Califf (former Commissioner of the U.S. Food and Drug Administration) – demonstrated:
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Improved study coordinator confidence and protocol readiness through simulation [Reference Taekman, Hobbs and Barber2].
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The value of “walking through” a trial using simulation to identify operational pitfalls [Reference Wright, Taekman, Barber, Hobbs, Newman and Stafford-Smith3].
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Evidence of learning curves in protocol adherence, highlighting the importance of pre-implementation rehearsal [Reference Taekman, Stafford-Smith and Velazquez4].
While the current paper appears to have been developed independently, I write to provide this context for historical completeness and to encourage recognition of simulation as a field-tested methodology with a deeper legacy in clinical research operations than is often cited. I appreciate the authors’ open and collegial response to this point and their invitation to continue the conversation.
As interest in simulation grows across the translational science ecosystem, I hope this lineage is helpful to other investigators working at the intersection of protocol development, human performance, and team science.
Competing interests
Dr Taekman is the owner of Knowvigate LLC, a consulting company whose activities include work related to simulation methods and clinical trial development.