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On the prior use of high-fidelity simulation to improve clinical trial development and implementation

Published online by Cambridge University Press:  22 January 2026

Jeffrey Taekman*
Affiliation:
Professor Emeritus of Anesthesiology, Duke University School of Medicine , Durham, NC, USA
*
Corresponding author: J. Taekman; Email: jeffrey.taekman@duke.edu
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Abstract

Information

Type
Letter
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
Copyright
© The Author(s), 2026. Published by Cambridge University Press on behalf of Association for Clinical and Translational Science

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:

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.

References

Dadiz, R, Jones, R, Guillet, R. Simulation as a potential tool for successful clinical trial initiation. J Clin Transl Sci. 2024;8:e109.10.1017/cts.2024.559CrossRefGoogle ScholarPubMed
Taekman, JM, Hobbs, G, Barber, L, et al. Preliminary report on the use of high-fidelity simulation in the training of study coordinatorsconducting a clinical research protocol. Anesth Analg. 2004;99:521527.10.1213/01.ANE.0000132694.77191.BACrossRefGoogle ScholarPubMed
Wright, MC, Taekman, JM, Barber, L, Hobbs, G, Newman, MF, Stafford-Smith, M. The use of high-fidelity human patient simulation asan evaluative tool in the development of clinical research protocols and procedures. Contemp Clin Trials. 2005;26:646659.10.1016/j.cct.2005.09.004CrossRefGoogle Scholar
Taekman, JM, Stafford-Smith, M, Velazquez, EJ, et al. Departures from the protocol during conduct of a clinical trial: a pattern fromthe data record consistent with a learning curve. Qual Saf Health Care. 2010;19:405410.Google Scholar