JSM 2011 Online Program

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Abstract Details

Activity Number: 339
Type: Topic Contributed
Date/Time: Tuesday, August 2, 2011 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301459
Title: Some Practical Issues in PFS Analysis from Industry Perspective
Author(s): Jingyuan Wang and Connie Lee and Jing Xu and Yuanjun Shi*+
Companies: Millennium Pharmaceuticals and Millennium Pharmaceuticals and Millennium Pharmaceuticals and Millennium Pharmaceuticals
Address: , , ,
Keywords: PFS ; censoring ; interval censored
Abstract:

We will talk on a few practical issues in PFS analyses. Monte Carlo simulations are used to study the impact of various methods on events time and censoring handling, including unscheduled assessments, frequency of assessments, start of new therapies etc. Methods recommended by regulatory agencies will be discussed. Theoretical explanation may be provided to support some of the simulation results.


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