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Activity Number: 636
Type: Topic Contributed
Date/Time: Thursday, August 13, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #315235
Title: Sample Size Adjustment Based on Promising Interim Results and Its Application in Confirmatory Clinical Trials
Author(s): Joshua Chen*
Companies: Sanofi Pasteur
Keywords: sample size adjustment; promising
Abstract:

We consider application of sample size adjustment (SSA) in carefully planned and well-designed Phase 3 confirmatory trials. In such a clinical setting, SSA is not intended to re-design the ongoing trial; instead, it is to ensure that the ongoing study can meet the study objective at the end, if in fact the treatment is efficacious. SSA based on promising interim results, or conditional power being greater than 50%, is particularly useful in mitigating the risk. No modification to the conventional statistical procedure is necessary while the type I error rate is controlled. The conventional unweighted test statistics and critical values can be used without any change. This "no interference", or no change to the conventional statistical procedure with or without SSA, is important for confirmatory trials. Similarly, carefully planned and well-designed group sequential studies can also benefit from SSA to mitigate the risk of failing to meet the study objective. Two hypothetical trials using real clinical trial data are used to illustrate the SSA method and caution about the risk of increasing sample size for an ineffective therapy if interim results are not promising.


Authors who are presenting talks have a * after their name.

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