JSM 2004 - Toronto

Abstract #301568

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Activity Number: 291
Type: Topic Contributed
Date/Time: Wednesday, August 11, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301568
Title: Post-randomization Change in Cancer Treatment: Statistical Analysis of Treatment Effect (2)
Author(s): Shenghui Tang*+ and Ning Li
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address: 1451 Rockville Pike, Rockville, MD, 20852,
Keywords: longitudinal data analysis ; survival analysis
Abstract:

Treatment effect in a randomized oncology study may be obscured due to changes in study arms prior to assessing the primary endpoint. The following approaches will be discussed to adjust the treatment effect due to treatment changes: (1) Longitudinal data up to the treatment change will be used in analysis while informative reasons for the treatment change will be incorporated through a joint model using a linear mixed effects model for repeated measurements and a proportional hazards model with competing risks for the treatment cross-over. (2) Time-to-event data after the cross-over will be modeled using measures at the switching time point to estimate treatment effect.

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Revised March 2004