Clinical trials simulation: a statistical approach

J Biopharm Stat. 2008;18(4):611-30. doi: 10.1080/10543400802071303.

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.

Publication types

  • Comparative Study

MeSH terms

  • Clinical Trials as Topic / methods
  • Clinical Trials as Topic / statistics & numerical data*
  • Computer Simulation*
  • Humans
  • Models, Statistical*
  • Patient Dropouts / statistics & numerical data