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What is the Clinical Trial Simulator (CTS)? |
A free software package that can simulate Randomized Controlled
Clinical Trials (RCTs). With the CTS a user can explore aspects
of the design, conduction and analyses of RCTs |
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Pragmatic
Randomized Controlled Trials In Health Care
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Typically, the user conceives a trial, including risk subgroups,
sample size, outcome rates, effect size, lost to follow-up,
compliance, stopping rules, etc. Then the program generates 1000s of
such trials. A summary of the results is presented, including
relative risks, relative risk reductions, confidence intervals,
p-values, etc. A number of graphics is also available. The simulator
also includes a sample size calculator for cluster or individually
randomized trials. |
To
learn how to design, analyze and report RCTs. The program tries to comply
with the recommendations of the CONSORT
statement when reporting the results of the trials.
To answer questions like: "What if I lose 30% of the patients?",
or "What if 10% of the patients do not take their study pills? What
is the likely impact of these problems on the results of the study?
In the current version the user can define the proportion of patients
that are lost-to-follow-up, and the proportion not complying with assigned
intervention, in one or more populations subgroups.
Explore the impact of sample size on study results. Can be also used as
a sample size calculator, taking into account the impact of lost to follow-up
and protocol violations.
Explore the impact on sample size of changing inclusion / exclusion
criteria by changing the risk profile of study subjects.
To use and teach "physiological
statistics".
The
development of this simulator was partially supported by PRACTIHC
with funding from the European Commission's 5th Framework
international collaboration with Developing Countries, Research
Contract. ICA4-CT-2001-10019, and by the Global Health Research
Initiative (GHRI) of the Canadian Institutes of Health Research (CIHR).
The
simulator was inspired on a trial simulator developed by D.W. Taylor,
E.G. Bosh and D. Sacket in 1990. (D.W. Taylor, E.G. Bosch. CTS: a clinical
trials simulator, Statistics in Medicine, 9:787-801,1990). [MEDLINE]
IcebergSim was designed by Eduardo Bergel and David Sackett. Eduardo
Bergel is the main developer. Luz Gibbons participated in the
development of the Cluster and the Stopping Rules Modules, and as a beta
tester. The logo was designed by Steve Janzen.
Marcelo
Delgado,
Alvaro Ciganda
and Martin Silva participated in the development of the previous version
(v 1.0).
The software was developed using the python programming language, with
the qt GUI toolkit. Graphics were developed using and external, free
graphic library (PLOTICUS).
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