The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures

Melanie C. Wright, Jeffrey M. Taekman, Linda Barber, Gene Hobbs, Mark F. Newman, Mark Stafford-Smith

Research output: Contribution to journalArticlepeer-review

23 Scopus citations


Errors in clinical research can be costly, in terms of patient safety, data integrity, and data collection. Data inaccuracy in early subjects of a clinical study may be associated with problems in the design of the protocol, procedures, and data collection tools. High-fidelity patient simulation centers provide an ideal environment to apply human-centered design to clinical trial development. A draft of a complex clinical protocol was designed, evaluated and modified using a high-fidelity human patient simulator in the Duke University Human Simulation and Patient Safety Center. The process included walk-throughs, detailed modifications of the protocol and development of procedural aids. Training of monitors and coordinators provided an opportunity for observation of performance that was used to identify further improvements to the protocol. Evaluative steps were used to design the research protocol and procedures. Iterative modifications were made to the protocol and data collection tools. The success in use of human simulation in the preparation of a complex clinical drug trial suggests the benefits of human patient simulation extend beyond training and medical equipment evaluation. Human patient simulation can provide a context for informal expert evaluation of clinical protocol design and for formal "rehearsal" to evaluate the efficacy of procedures and support tools.

Original languageEnglish
Pages (from-to)646-659
Number of pages14
JournalContemporary Clinical Trials
Issue number6
StatePublished - Dec 2005

Bibliographical note

Funding Information:
This work was funded by grant No. R01 NS049548 from the National Institute of Neurological Disorders and Stroke (Bethesda, Maryland) and the Office of Research Integrity (Rockville, Maryland); the Global Perioperative Research Organization, Durham, NC; and the Department of Anesthesiology, Duke University Medical Center, Durham, NC. We would like to thank Elisabeth Williams and Kate Davis of the START (Study Tools and Resources for Trials) team of the Duke Clinical Research Institute (DCRI) of Durham, NC for their efforts in the development of the data collection and instructional tools presented in Appendices A, B, and C . The DCRI START team collaborates with project leaders and site-management team members to develop user-friendly, trial-specific materials such as pocket cards, worksheets, patient educational materials, and study manuals.


  • Clinical research
  • Clinical trials
  • Human factors
  • Human-centered design
  • Simulation
  • User centered design

ASJC Scopus subject areas

  • Pharmacology (medical)


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