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Abstract Details
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Activity Number:
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70
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Type:
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Contributed
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Date/Time:
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Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301982 |
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Title:
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Predicting Data Cutoff Dates for Event-Driven Randomized Survival Clinical Trials Before and During Study Conduct
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Author(s):
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Ying Tian*+ and Alan Rong and Alicia Zhang and Hua Yu
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Companies:
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Amgen Inc. and Amgen Inc. and Amgen Inc. and Amgen Inc.
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Address:
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1 Amgen Center Dr, Thousand Oaks, CA, 91320,
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Keywords:
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Event Projection ;
Oncology Therapeutic Trial ;
Survival Analysis ;
Copula Function ;
PFS
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Abstract:
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Time to event endpoints are commonly used in randomized trials in Oncology, where the power or precision for the treatment comparisons is determined by the number of observed events. In this presentation, we will propose some methods to estimate the earliest data cutoff date to achieve the target event goals. At the design stage, an expected cutoff date can be obtained based on design assumptions. Once the study is initiated, the design stage parameters become less relevant over time as interim data accumulates. Interim data may then be utilized to refine the projected cutoff date. Special cases raise additional issues, e.g., a lag time in event reporting, and discordance with central versus investigator radiologic progression. Proposed solutions to these issues will be discussed.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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