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Sessions Were Renumbered as of May 19.

CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

254 * ! Mon, 8/1/2016, 2:00 PM - 3:50 PM CC-W192c
Early-Phase Clinical Trials: Setting the Stage for Success — Contributed Papers
Biopharmaceutical Section
Chair(s): Yanxun Xu
2:05 PM Randomization does not prevent bias when we assess treatment by covariate interaction Lei Nie, FDA ; Zhiwei Zhang, FDA/CDRH ; Jialu Zhang, FDA
2:20 PM Application of Propensity-Score Matching in Data Augmentation of Randomized Clinical Trials: A Case Study Junjing Lin, AbbVie ; Margaret Gamalo-Siebers, Eli Lilly and Company ; Ram Tiwari, FDA/CDER/OT/OB
2:35 PM Enabling Robust PK/QTc Assessment in Single and Multiple Ascending Dose Trials for Evaluation of QTc Prolongation Fang Liu, Merck ; Li Fan, Merck ; Kuenhi Tsai, Merck ; Devan V. Mehrotra, Merck
2:50 PM Enrichment Design with Patient Augmentation for Time-to-Event Data Yijie Zhou, AbbVie ; Bo Yang, Vertex Pharmaceuticals ; Lanju Zhang, AbbVie ; Lu Cui, AbbVie
3:05 PM Dose-Ranging Design and Analysis Based on MCP-Mod to Identify the Minimum Effective Dose (MED) Ying Zhang, AbbVie ; Su Chen, AbbVie ; Yihan Li, AbbVie ; Wangang Xie, AbbVie ; Yijie Zhou, AbbVie ; Li Wang, AbbVie ; Alan Hartford, AbbVie
3:20 PM Optimal Borrowing of Historical Control Data in Clinical Trials Saurabh Mukhopadhyay, AbbVie ; Qi Tang, AbbVie ; Alan Hartford, AbbVie
3:35 PM Never Fit Sequence: The Design and Analysis of Multi-Period Clinical Trials Hans Hockey, Biometrics Matters Ltd.
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