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Chapter 5 - Clinical Trial Simulations

from Part II - Basic Ingredients for Adaptive Trial Designs and Common Types

Published online by Cambridge University Press:  20 March 2023

Jay J. H. Park
Affiliation:
McMaster University, Ontario
Edward J. Mills
Affiliation:
McMaster University, Ontario
J. Kyle Wathen
Affiliation:
Cytel, Cambridge, Massachusetts
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Summary

In this chapter, we discuss the use of simulations for clinical trials. Simulation in statistics generally refers to repeated analyses of randomly generated datasets with known properties. Clinical trial simulation is required to explore, compare, and characterise operating characteristics and statistical properties of adaptive and other innovative trials with complex designs. Clinical trial simulation is an important tool that allows for comparison of different design choices during the planning stage to enhance the quality and feasibility of the trial. While simulations are most frequently used in adaptive and other complex trial designs, they can be applied to fixed trial designs.

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Publisher: Cambridge University Press
Print publication year: 2023

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