This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 554
Type: Invited
Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
Sponsor: ENAR
Abstract - #306112
Title: Simulation of a Phase III Trial Using Realizations of Posterior Distribution Based on a Phase IIb Trial
Author(s): A. Lawrence Gould*+
Companies: Merck Research Laboratories
Address: , , ,
Keywords: Trial Design ; Prediction ; Bayesian

Simulation of Phase 3 trial outcomes on the basis of findings from Phase 2 trials is an efficient way to explore design alternatives, but generally requires a number of assumptions about the distribution of key parameters. Directly using a large number of realizations from the posterior distribution of the parameters based on the findings from a Phase 2 trial obviates the need for many of the distributional assumptions and, in addition, explicitly accommodates correlations among the parameters. This presentation describes the process and its implementation in the design of a Phase 3 trial.

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