This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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569
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #306377 |
Title:
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Adaptive Dose Finding Using the 'Maximizing Procedure': Case Study and Missing Data Simulation
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Author(s):
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Kenneth Liu*+
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Companies:
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Merck & Co., Inc.
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Address:
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, , ,
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Keywords:
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Three period crossover study ;
Active control ;
Sample size ;
Isotonic regression ;
Missing data mechanism
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Abstract:
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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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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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