Please visit www.randomization.org <http://www.randomization.org/>  for more
information and to download the simulator.



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.



How it works?



Typically, the user conceives a trial, including patients subgroups, sample
size, outcome rates, effect size, lost to follow-up, patients compliance,
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.



What can be used for?



The CTS can be used for a number of different things:



Learn how to analyze and report RCTs. The program tries to comply with the
recommendations of the CONSORT statement when reporting the results of the
trials.

Explore the impact of sample size on study results. Can be also used as a
sample size calculator, although it is not its main objective.

Explore the potential impact of problems during the conduction of a trial.
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.



This program is one of the tools been developed by PRACTIHC (Pragmatic
Randomized Controlled Trials In Health Care). Please visit the PRACTIHC
website for more information (www.practihc.org).



Current state



The simulator is in Beta version, meaning that is under active development,
and might produce unexpected results.



Funding



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, by the Latin American Center for Perinatology (CLAP -
PAHO/WHO) and by the Global Health Research Initiative (GHRI) of the
Canadian Institutes of Health Research (CIHR).



Development



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).



The CTS was developed by Eduardo Bergel and a team of programmers (Marcelo
Delgado, Alvaro Ciganda and Martin Silva) at the Latin American Center for
Perinatalogy, in Montevideo, Uruguay.

The software was developed  under Microsoft .NET using C#. It turn out that
there were no good graphic libraries in .NET and the graphics were developed
using and external, free graphic library (PLOTICUS).