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Design and Analysis of Clinical Trial Simulations

Kazuhiko Kuribayashi ()
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Kazuhiko Kuribayashi: Pfizer Japan Inc.

Chapter Chapter 8 in Developments in Statistical Evaluation of Clinical Trials, 2014, pp 139-151 from Springer

Abstract: Abstract Clinical trial simulation is a powerful tool for supporting decision making in designing clinical trials, and plays an important role in clinical research and drug development. In clinical trial simulation, however, the design is often not well-considered and the results are empirically assessed. In this chapter, we present points to consider when planning a clinical trial simulation, and discuss how to design a clinical trial simulation employing a fractional factorial design and how to analyze the simulation results.

Keywords: Clinical Trial Simulation (CTS); Monte Carlo Error; Expected Sample Size; Full Factorial Experiment; Simulation Replications (search for similar items in EconPapers)
Date: 2014
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-642-55345-5_8

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DOI: 10.1007/978-3-642-55345-5_8

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