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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 - #300948 |
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Title:
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Consequences of Asymmetry in Progression Assessments
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Author(s):
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Shenghui Tang*+ and Chris Holland 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 Hampshire Avenue, Silver Spring, MD, 20993,
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Keywords:
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Asymmetry ; Simulation ; False Positive Rate ; Disease Growth Rate ; Cancer
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Abstract:
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Progression-free survival defined as the time from randomization to either progression or death, is one of the efficacy endpoints used in evaluating oncology drug products. Disease progression is generally measured using pre-defined criteria at a pre-planned frequency of visits. Some studies have shown that asymmetry in pre-defined progression assessments between the treatment arms can introduce bias and confound the true treatment differences. In this study we examine the impact of asymmetry with respect to false positive rate using simulations when (1) the scheduled assessments are made for different lengths of visits, (2) the disease under consideration is fast growing versus slow growing, and (3) the percentage of censored data varies.
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