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659 | Thu, 8/13/2015, 8:30 AM - 10:20 AM | CC-613 | |
Methods in Clinical Trials 2 — Contributed Papers | |||
Biopharmaceutical Section | |||
Chair(s): Maureen Reiner, Amgen | |||
8:35 AM | Validity and Power Considerations on Hypothesis Testing Under Minimization — Zhenzhen Xu, FDA ; Michael Proschan, NIH/NIAID ; Shiowjen Lee, FDA | ||
8:50 AM | Establishing Equivalence Margins for a Ph3 Biosimilar Trial in Rheumatoid Arthritis: From Choice of Endpoints to Regulatory Experience — Steven Y. Hua, Pfizer Research and Development ; Kerry Barker, Pfizer Inc. | ||
9:05 AM | Treatment Response Subgroup Identification Using Penalized Regression Spline and Mixture Models — Hongjie Zhu, Sanofi ; Lin Wang, Sanofi ; Lynn Wei, Sanofi ; Hui Quan, Sanofi | ||
9:20 AM | Using Tree-Based Methods for Identifying Predictive Biomarker in Clinical Trials — Michael Man ; Wei-Yin Loh, University of Wisconsin | ||
9:35 AM | Statistical Considerations in Detecting Circulating Tumor DNA Using Digital PCR — Shibing Deng, Pfizer Inc. ; Maruja Lira, Pfizer Inc. | ||
9:50 AM | From Statistical Power to Statistical Assurance: It's Time for the Paradigm Change in Clinical Trial Design — Din Chen, University of Rochester ; Shuyen Ho, GSK | ||
10:05 AM | Using a Predictive Probability Design for Faster Decision-Making in an Early-Phase Oncology Trial — Sharon Murray, PAREXEL International ; Grace Zhang, Merck ; Allison Florance, GlaxoSmithKline |
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