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High-Fidelity Simulation of Clinical
Research Protocols
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 work closely with the Duke
Clinical Research Institute (DCRI) and the Global
Perioperative Research Organization (GPRO) as well as individual
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:
- Pre-enrollment Protocol Walkthroughs: 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).
- 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. (accepted for publication September 2005,
Contemporary
Clinical Trials).
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.
Morgan, Pamela J a; Cleave-Hogg, Doreen, Simulation technology
in training students, residents and faculty. Current
Opinion in Anaesthesiology. 18(2):199-203, April 2005.
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 Jeffrey M. Taekman, M.D.,
Director, Human Simulation and Patient Safety Center (919-684-3661
or jeffrey.taekman@duke.edu
).
(download
a brochure on high-fidelity simulation of clinical trials)
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