JSM 2004 - Toronto

Abstract #300515

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Activity Number: 112
Type: Contributed
Date/Time: Monday, August 9, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #300515
Title: Tests for Time to a Favorable Event
Author(s): David R. Bristol*+ and Nicole O. Stouffer
Companies: and Purdue Pharma LP
Address: 59 Cottonwood Court, Monmouth Junction, NJ, 08852,
Keywords: censoring ; analgesia
Abstract:

When assessing the time to success (favorable event), the times to failure (unfavorable event) can be handled in various ways. Small times to success are consistent with a response to an effective treatment; also, large times to failure may contribute to the evidence of an effective treatment. The approaches considered here are to treat the unfavorable events as (1) censoring events at the time of occurrence, (2) censoring events at the end of the study (EOS), or (3) observed events at EOS. The analyses for between-treatment comparisons are the log-rank and the (generalized) Wilcoxon tests when the unfavorable events are considered censoring events and the Wilcoxon rank sum test when the unfavorable events are considered observed events at EOS. The methods of data handling and analysis may affect the significance of the treatment differences. Results of simulations, conducted using various exponential distributions for times to success and failure, are presented to examine the impact. If the two treatments have the same distributions of the time to failure, the log-rank test is preferable.

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