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

Abstract Details

Activity Number: 569
Type: Topic Contributed
Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306377
Title: Adaptive Dose Finding Using the 'Maximizing Procedure': Case Study and Missing Data Simulation
Author(s): Kenneth Liu*+
Companies: Merck & Co., Inc.
Address: , , ,
Keywords: Three period crossover study ; Active control ; Sample size ; Isotonic regression ; Missing data mechanism
Abstract:

This is a case study of a recent clinical trial that combines proof-of-concept with dose finding. Proof-of-concept in clinical trials usually focuses on identifying a maximum tolerated dose (MTD) and assumes that higher doses provide better efficacy. However adverse events associated with an MTD may blunt efficacy. We present an adaptive dose-finding strategy which concentrates assignments at and around the dose which has the best efficacy/tolerability profile based on a utility function. The strategy is applied to a three period crossover design to improve power and allow for inclusion of an active control. Operating characteristics over various efficacy/tolerability scenarios and missing data mechanisms (MCAR, MAR, NMAR, and a mixture of the three) were studied via simulation. Advantages and disadvantages of this adaptive design versus traditional trial designs will be discussed.


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