This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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501
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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 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #306417 |
Title:
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A Comparison of the Results of Intent-to-Treat, per-Protocol, and g-Estimation in the Presence of Nonrandom Treatment Changes in a Time-to-Event Noninferiority Trial
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Author(s):
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Yutaka Matsuyama*+
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Companies:
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The University of Tokyo
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Address:
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7-3-1 Hongo, Bunkyo-ku, Tokyo, 1130033, Japan
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Keywords:
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g-estimation ;
Inten-to-treat ;
non-compliance ;
non-inferiority trials ;
per-protocol ;
randomization-based analysis
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Abstract:
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It has often been said that ITT analysis tends to be anti-conservative in demonstrating non-inferiority, suggesting that PP analysis may be preferable. We propose using randomization-based g-estimation analyses that more effectively preserve the integrity of randomization. Simulation studies were conducted to investigate the impacts of different types of treatment changes on the conservatism or anti-conservatism of analyses using ITT, PP, and g-estimation in a time-to-event outcome. ITT results were anti-conservative for all simulations. For outcome-dependent treatment change, PP analysis was either conservative or anti-conservative. G-estimation analysis maintained type I error near the nominal level even for outcome-dependent case. Randomization-based g-estimation analyses should be used to supplement the more conventional ITT and PP analyses, especially for non-inferiority trials.
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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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