JSM 2015 Preliminary Program

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Legend: Washington State Convention Center = CC, Sheraton Seattle = S, Grand Hyatt = GH and The Conference Center = TCC
* = applied session       ! = JSM meeting theme

Activity Details
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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