JSM 2011 Online Program
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Activity Details
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| CE_30T | Wed, 8/3/2011, 10:00 AM - 11:45 AM | HQ-Poinciana Salon 4 | |
| New Developments in East® and SiZ® MCP: Designing and Simulating Confirmatory Trials with Multiple Treatment Arms — Continuing Education CTW | |||
| ASA , Cytel Software Corporation | |||
| Instructor(s): Cyrus Mehta, Cytel Inc. | |||
| A problem of increasing importance for later stage study design and analysis is the comparison of more than one treatment arm to the control arm. In contrast to conventional phase 3 clinical studies with two-arm trials involving a single endpoint,it's now common to include two or more dose groups of the experimental therapy along with an active comparator and possibly placebo, too. Such trials often involve multiple hierarchical objectives with logical relationships among them making testing for some objective conditional on the positive/negative test outcome on another objective. Regulators require that data analysis from such trials - where multiple claims of efficacy may be made in the product label - must be handled by multiple comparison procedures that guarantee strong control of the familywise error rate (FWER). We'll explore such methods while also demonstratingthe recently releasedMultiple Comparison Methodsand SiZ®software. Attendees will see how our newuser interface enables simultaneous specification and simulation of multiple design scenarios, including external calls to R and SAS. The same UI will be the basis for future versions of East®, making practicalsingle look, group sequential, adaptive and multiple comparisons procedures to work together in a unified manner. | |||
2011 JSM Online Program Home
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