Simulation of clinical trials: a review with emphasis on the design issues

GIOVAGNOLI, ALESSANDRA; Department Of Statistical Sciences - University Of Bologna & ZAGORAIOU, MAROUSSA; Department Of Statistical Sciences - University Of Bologna
Simulation is a widely used tool to investigate real-world systems in a large number of fields, including clinical trials for drug development, since real trials are costly, frequently fail and may lead to serious side effects. This paper is a survey of the statistical issues arising in these simulated trials, with particular emphasis on the design of such virtual experiments, stressing similarities and differences with the design of real trials. We discuss the aims and...