 |
 |
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).