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Activity Details

CE_31T Wed, 8/7/2013, 10:00 AM - 11:45 AM W-Ville-Marie
Compass 2.0: Software for the Design and Execution of Dose-Finding Trials — Continuing Education CTW
ASA , Cytel Software Corporation
Instructor(s): James Bolognese, Cytel, Charles Liu, Cytel Inc.
"The high failure rate of phase 3 clinical trials is often attributed to selection of an inappropriate dose level fromearly stages. The consequences of getting the dose right, or not, significantly impacts the entire development program. Designing phase 2 dose finding trial poses a significant statistical challenge: to efficiently find a range of dose levels that are neither too low and ineffective, nor too high and unsafe. Compared with traditional approaches, adaptive designs can more effectively identifytarget doses with substantial savings in sample size. Compass® extends Cytel's extensive experience in statistical software development, including popular East® and StatXact®. Compass combine an intuitive user interface - connected to a powerful computational engine - for a natural workflow to efficiently design, simulate and deploy the optimal dose selection study. Workshop attendees will learn using new Compass 2.0 to compare, assess, and implement an adaptive Phase 2 design. Features examined include: (1) a randomization dashboard to perform randomization, conduct interim data analysis and update allocation ratios; (2) two-stage (dose dropping) designs; (3) the Gibbs sampling algorithm and Monte Carlo diagnostics; and (4) stopping rules for futility based on conditional power. "

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