Description:
This handbook provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives and presents real-world examples of a range of adaptive designs. Leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies examine issues commonly encountered when applying adaptive design methods in clinical trials. They discuss the importance of sample size estimation/allocation, justification, and adjustment when implementing a complicated adaptive design.