JSM 2004 - Toronto

Abstract #300380

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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 - #300380
Title: Post-randomization Change in Cancer Treatment: Statistical Analysis of Treatment Effect (1)
Author(s): Peiling Yang*+ and Yong-Cheng Wang
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address: 1451 Rockville Pike, HFD-710, Rockville, MD, 20852,
Keywords: noncompliance ; survival analysis
Abstract:

In randomized studies of cancer treatments, oncologists may change treatments prior to assessing the primary endpoint, thus potentially obscuring treatment effects from study treatments. Reasons for change in therapy include drug toxicity, tumor progression, and changes in surrogate markers. This presentation will focus on estimating treatment effect when patients switch treatments from the assigned to the alternative after randomization in oncology clinical trials. We will explore the prognostic factors that may be correlated with treatment noncompliance and discuss issues in statistical analysis from the regulatory perspective.


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Revised March 2004