Group Sequential Methods for Clinical Trials

Randomized clinical trials are recognized as the most appropriate scientific methods for evaluation of new treatment for human diseases. Because of ethical imperatives in experimentation on humans, outcome data needs monitoring to protect participants from undue experimentation as regards to efficacy and safety. Group sequential methods provide scientifically rigorous and valid methods for monitoring of outcome data and for consideration of early stopping. TOC: Introduction * Group Sequential Methods * Information-based Monitoring and Design * Upper and Lower Boundaries * Other Related Methods * Inference Following Group A Sequential Test * Software * Case Studies