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Activity Number:
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1
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Type:
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Invited
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Date/Time:
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Sunday, August 2, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303036 |
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Title:
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Impact of Variability in Progression Assessments on Type I and Type II Errors
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Author(s):
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Shenghui Tang and Kun He*+ and Rajeshwari Sridhara and Xiaoping Jiang
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Companies:
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FDA and FDA
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Address:
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CDER/OB/DB5, 10903 New Hampshire Ave., Silver Spring, MD, 20993,
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Keywords:
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Progression-free survival ; Disease progression ; Progression assessment
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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 scheduled visits. The frequency and length of schedule visits are designed based on clinical practices and the natural history of disease. In this study we examine the impact on type I and type II errors as well as the estimated treatment effects using simulations when there are differences in (1) the overall length of scheduled assessments, (2) more visits during treatment and fewer visits in the follow-up period, (3) the variability around the scheduled assessment times changes as trial continues, and (4) lengths of visit intervals changes as trial continues. We will examine these in several scenarios from fast growing to slow growing tumors.
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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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