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Activity Number:
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592
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 6, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305098 |
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Title:
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Comparing Statistical Approaches in Analysis of Clinical Trial Data with Patient Crossover
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Author(s):
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Tailiang Xie*+
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Companies:
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Brightech International
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Address:
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285 Davidson Ave, Suite 504, Somerset, NJ, 08873,
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Keywords:
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Randomized clinical trials ; Treatmen crossover ; survival analysis ; ITT analysis ; device clinical trials
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Abstract:
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More and more randomized trials allow patients in an active control to crossover an experimental therapy when disease was progressed. When such a crossover occurred, treatment effect of the experimental therapy was confounded. If the experimental therapy had a beneficial treatment effect, the crossover could result in an under-estimation of treatment difference. Otherwise, the crossover could result in an over-estimation of treatment difference. The conventional ITT analysis by ignoring the crossover could be severely biased if the percentage of subjects crossed is substantial. In this talk, we will discuss commonly used approaches for analyzing survival data in which the crossover had happened. Several alternative approaches will be proposed and compared via simulations and real examples in drug and medical device clinical trials.
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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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