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Abstract Details
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Activity Number:
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387
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305233 |
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Title:
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Multiple Primary Endpoints in Oncology Trials
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Author(s):
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Ai Li*+ and Bin Yao
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Companies:
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Amgen, Inc.
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Address:
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One Amgen Center drive, Thousand Oaks, CA, 91320, USA
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Keywords:
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group sequential trials ;
multiple endpoints ;
Multiplicity ;
primary endpoints ;
Oncology
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Abstract:
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In oncology trials, overall survival (OS) is the gold standard preferred by regulators. However, it is often challenging to demonstrate treatment effect on OS. A great deal of attention has been on the roles of endpoints such as PFS and duration of response in the drug approval process. Pivotal trials with either OS or PFS as the primary endpoint are very common. In some cases sponsors even switch endpoints in the middle of the trials. Based on the experience of an actual phase 3 oncology trial, we describe situations where it may be appropriate to consider OS and PFS as co-primary endpoints. We propose a procedure that takes into account the nature of the co-primary endpoints and the timing of different analyses (i.e. interim and final analyses).
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