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ISCB2014_abstract_book

88Monday25thAugustTuesday26thAugustThursday28thAugustAuthorIndexPostersWednesday27thAugustSunday24thAugust ISCB 2014 Vienna, Austria • Conference course Thursday, 28th August 2014 • 9:00-12:30 Conference course Course 7 Designing adaptive clinical trials Y Jemiai1 , R Mukherjee2 1 Cytel Inc., Cambridge, United States, 2 Cytel Inc., Geneva, Switzerland   The objective of this course is to provide practical strategies and tools for efficient decision-making via interim analyses of ongoing clinical trials, us- ing state-of-the-art methods for group sequential and adaptive designs. Topics covered will include group sequential design and monitoring with sample size re-estimation, preserving type-1 error, computing power, ob- taining point estimates, and computing confidence intervals in the adap- tive setting. We will also cover modern methods for model-based dose- escalation in Phase 1 oncology studies. Case studies in oncology and cardiology are used to reinforce the main points. The workshop includes a hands-on session with the East 6.3 soft- ware. Firsthand experience with East will be used throughout as a running ex- ample to illustrate concepts.

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