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We illustrate the use of marginal proportional hazards models and other survival models with various group sequential methods to test multiple survival endpoints at K interim analyses. However, when trials are conducted using a group-sequential design with interim analyses or can be extended using an adaptive design with an increase of sample size or total number of events, this conventional hierarchical testing strategy may violate the closure principle and the overall type I error rate may not be controlled in the strong sense. This research gives methods for sequential monitoring of survival data in clinical trials with multiple endpoints.
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This testing strategy ensures a strong control of the overall type I error.
#GROUP SEQUENTIAL TESTING TRIAL#
In conventional fixed designs without any interim analysis or trial extension, these endpoints are often tested in a pre-specified hierarchical order, following the closed testing principle. Several authors have proposed group sequential procedures to satisfy the ethicalneed in clinical trials for interim analyses. KEY WORDS: Acute respiratory distress syndrome Clinical trials Futility stopping rules Group sequential designs Hypothesis test Numerical integration. When the trial is completed and the primary efficacy endpoint achieves statistical significance, formal statistical testing of other clinically important secondary endpoints often follows in order for the statistically and clinically significant results of these endpoints to be included in the label of the test pharmaceutical product. Many clinical trials are designed with a fixed sample size or total number of events to detect a postulated size of treatment effect on a primary efficacy endpoint.