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Activity Number:
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217
- Theory and Algorithms for Adaptive Clinical Trial Design with Multiple Objectives
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Type:
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Invited
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Date/Time:
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Tuesday, August 9, 2022 : 8:30 AM to 10:20 AM
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Sponsor:
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WNAR
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Abstract #320465
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Title:
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Grammar of Group Sequential Design
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Author(s):
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Keaven M Anderson* and Yilong Zhang and Nan Xiao and Yujie Zhao
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
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Keywords:
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group sequential design;
software;
clinical trials;
multiplicity;
survival analysis
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Abstract:
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We discuss a general grammar intended for design and evaluation of group sequential designs. The objective is to allow writing and review of simple, readable code for a wide range of designs. This begins with simpler designs such as two-arm trials with binomial, normal or time-to-event designs under a proportional hazards assumption. Next, we consider asymptotic methods for non-proportional hazards with logrank and other test statistics. We then extend to more complex designs with multiple endpoints in a trial. This last topic can involve many endpoints, some of which have tests with known correlations. Both asymptotic methods and simulation are incorporated. All methods have been used in multiple trials over the last several years. However, we also strive to make the grammar extensible for further applications such as adaptive designs.
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Authors who are presenting talks have a * after their name.
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