• J Biopharm Stat · Jan 2008

    Comparative Study

    Clinical trials simulation: a statistical approach.

    • Peter H Westfall, Kuenhi Tsai, Stephan Ogenstad, Alin Tomoiaga, Scott Moseley, and Yonggang Lu.
    • Texas Tech University, Lubbock, Texas 79409-2101, USA. peter.westfall@ ttu.edu
    • J Biopharm Stat. 2008 Jan 1; 18 (4): 611-30.

    AbstractA generic template for clinical trials simulations that are typically required by statisticians is developed. Realistic clinical trials data sets are created using a unifying model that allows general correlation structures for endpoint*timepoint data and nonnormal distributions (including time-to-event), and computationally efficient algorithms are presented. The model allows for patient dropout and noncompliance. A grid-enabled SAS-based system has been developed to implement this model; details are presented summarizing the system development. An example illustrating use of the system is given.

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