JSM 2011 Online Program

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CE_26T	Wed, 8/3/2011, 8:00 AM - 9:45 AM	HQ-Poinciana Salon 4
Better Ways to Get the Dose Right with Cytel's New Compass — Continuing Education CTW
ASA , Cytel Software Corporation
Instructor(s): Jim Bolognese, Cytel Software Corporation
Designers of phase 1 and 2 dose-related studies are challenged to identify the right dose to carry forward into late stage development. The FDA's 2010 draft guidelines encourage adaptive designs use especially in this learning stage of clinical development. The PhRMA Adaptive Dose Response Group also hasshown that adaptive designs are often a substantial improvement on traditional studies. In similar fashion to Cytel's East®, the trusted adaptive and group sequential design software for late stage trials, Compass® stems from our considerable adaptive dose-finding biopharma client experience.Offering an array of both frequentist or Bayesian-based methods, Compass® provides a sensible workflow specifically for designing, simulating and comparing dose finding studies. Workshop attendees will learn what to consider in determining the most suitable dose-finding study adaptive method, practicalities of simulating and comparing the operating characteristics of different trial design candidates, and how to design a single study that addresses multiple research objectives.

2011 JSM Online Program Home

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