Duke University Human Simulation and Patient Safety Center is pioneering the use of high-fidelity simulation in the deployment of clinical research protocols.
Our methods make clinical trials safer for patients and less costly for sponsors.
We can replicate ANY clinical location.
Our investigative group, the Research Organization on Clinical Trials (ROCT) is building an argument for the use of high-fidelity simulation in two distinct phases of protocol development.
1. Pre-enrollment Protocol Walkthrough (Protocol Design): Protocol developers observe their study performed by research personnel in a simulated clinical setting PRIOR to subject enrollment. Walkthroughs highlight potential protocol errors and inefficiencies early in the deployment cycle (thereby minimizing subject exposure, minimizing amendments, improving study “usability” and improving data quality).
2. Research Personnel Training: Learning curves are present in all complex human behaviors (performance improves with repetition). Proper performance of a clinical trial depends upon complex, intertwined behaviors of the research team. Training research personnel in simulated environments allow monitors, coordinators, and investigators to make mistakes without risk to enrolled subjects or data integrity. Upon conclusion of simulation training, the research personnel are closer to optimal performance when subject enrollment begins.
The potential impact of these training methods include: improved patient safety, fewer protocol amendments, fewer data queries, improved data quality, and faster completion of studies.
Literature highlighting the use of high-fidelity simulation in clinical trials:
- Wright MC, Taekman JM, Barber L, Hobbs G, Newman MF, Stafford-Smith M. The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures. Contemp Clin Trials. 2005 Dec;26(6):646-59. Epub 2005 Oct 14. (pubmed)
- Stafford-Smith M, Lefrak EA, Qazi AG, et al. Efficacy and safety of heparinase I versus protamine in patients undergoing coronary artery bypass grafting with and without cardiopulmonary bypass. Anesthesiology 2005;103(2):229-40. (pubmed)
- Taekman JM, Stafford-Smith M, Velazquez EJ, Wright MC, Phillips-Bute BG, Pfeffer MA, Sellers MA, Pieper KS, Newman MF, Van de Werf F, Diaz R, Leimberger J, Califf RM. Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve. Qual Saf Health Care. 2010 Oct;19(5):405-10. Epub 2010 Aug 10. (pubmed)
- Taekman JM, Hobbs G, Barber L, Phillips-Bute BG, Wright MC, Newman MF, Stafford-Smith M. Preliminary report on the use of high-fidelity simulation in the training of study coordinators conducting a clinical research protocol. Anesthesia & Analgesia 2004 99 (2):521-7. (abstract) (pubmed)
For further information please contact Ankeet D. Udani, MD, MSEd, Director, Human Simulation and Patient Safety Center (919-684-3661 or ankeet.udani@duke.edu).