title: Clinical trials simulation: a statistical approach.
abstract: A 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.
authors.affiliation: Texas Tech University, Lubbock, Texas 79409-2101, USA. peter.westfall@ ttu.edu
authors.forename: Peter H
authors.initials: PH
authors.lastname: Westfall
authors.forename: Kuenhi
authors.initials: K
authors.lastname: Tsai
authors.forename: Stephan
authors.initials: S
authors.lastname: Ogenstad
authors.forename: Alin
authors.initials: A
authors.lastname: Tomoiaga
authors.forename: Scott
authors.initials: S
authors.lastname: Moseley
authors.forename: Yonggang
authors.initials: Y
authors.lastname: Lu
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D003198:Computer Simulation; D006801:Humans; D015233:Models, Statistical; D010352:Patient Dropouts / Q000706:statistics & numerical data