S+SeqTrial is an S-PLUS software library for designing, monitoring, and analyzing clinical trials using group sequential methods. In a classical fixed sample design, the sample size is set in advance of collecting any data. In sequential design, data are monitored throughout the collection, and the data may be analyzed after a block of data is accrued. This is especially beneficial if electronic data capture (EDC) methods are used for data collection.
Group sequential designs are especially important for the design of Phase II and Phase III clinical trials, where ethical considerations such as patient safety and rapid approval of effective treatments are paramount. Indeed, the FDA now recommends group sequential studies in certain cases.
Key Benefits
* Reduced clinical trial costs using group sequential methods
* Improved study design and comprehensive design and evaluation tools
* Flexible monitoring methods
* Advanced visualization tools for analyzing and interpreting results
Statistical analysis software
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