Clinical trials simulation: a statistical approach.
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.
Westfall
Peter H
PH
Texas Tech University, Lubbock, Texas 79409-2101, USA. peter.westfall@ ttu.edu
Tsai
Kuenhi
K
Ogenstad
Stephan
S
Tomoiaga
Alin
A
Moseley
Scott
S
Lu
Yonggang
Y
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