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Activity Number:
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240
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Type:
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Contributed
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Date/Time:
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Tuesday, August 5, 2008 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300942 |
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Title:
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Relationship Between Type I/II Errors and Frequency of Progression Assessment
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Author(s):
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Xiaoping Jiang*+ and Kun He and Rajeshwari Sridhara
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration
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Address:
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10903 New Hapmshire Ave, SIlver Spring, MD, 20993,
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Keywords:
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Progression free survival ; type I error ; log-rank test ; Interval censoring ; Type II error
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Abstract:
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Progression free survival (PFS) is defined as the time from randomization to disease progression or death by any cause, and is commonly used as an endpoint of clinical trials in evaluating oncology drug products. Disease progression is assessed by applying pre-defined criteria at pre-planned frequency of visits. Disease progression assessments are expensive and therefore disease monitoring frequency is generally guided by clinical practice based on the natural history of the disease. In this paper we examine by simulation study the impact of frequency of assessment on statistical testing, especially, the relationship between statistical testing errors (Type I and II) and the frequency of assessment.
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