JSM 2011 Online Program
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Activity Details
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37 * | Sun, 7/31/2011, 2:00 PM - 3:50 PM | CC-A208 | |
Topics with Placebo Response and Historical Control — Contributed Papers | |||
Biopharmaceutical Section | |||
Chair(s): Cindy Xu, Novartis | |||
2:05 PM | Estimating Putative Placebo in the Two-Arm Noninferiority Clinical Trial — Abdul J. Sankoh, Vertex Pharmaceuticals ; Cynthia DeSouza, Vertex Pharmaceuticals | ||
2:20 PM | The Evaluation of the Sequential Parallel Design: A Design Strategy to Deal with High Placebo Response in Psychiatric Clinical Trials — Yang Yang, U.S. Food and Drug Administration ; Yeh-Fong Chen, U.S. Food and Drug Administration ; H.M. James Hung, U.S. Food and Drug Administration ; Sue-Jane Wang, U.S. Food and Drug Administration/CDER | ||
2:35 PM | Adjusting for Patients' Unmasking in Clinical Trials: Estimation of Direct Effects in Longitudinal Studies — Farid Jamshidian, University of California at Berkeley ; Alan Hubbard, University of California at Berkeley ; Nicholas P. Jewell, University of California at Berkeley | ||
2:50 PM | Estimation of the Adverse-Events Warning Signal Through the Historical Event Rate — Qian F. Graves, U.S. Food and Drug Administration ; Peng Tu Liu, U.S. Food and Drug Administration ; Stuart Chirtel, U.S. Food and Drug Administration | ||
3:05 PM | Analytical and Statistical Considerations for Prospectively Collected Data on Suicidal Thoughts and Behaviors — Mary E. Nilsson, Eli Lilly and Company ; Shailaja Suryawanshi, Merck & Co., Inc. ; Cristiana Gassmann-Mayer, Johnson & Johnson Pharmaceutical R&D, LLC ; Sarah Dubrava, Pfizer Inc. ; Paul A. McSorley, GlaxoSmithKline Beecham ; Kaihong Jiang, sanofi-aventis ; Ramin Arani, Bristol-Myers Squibb | ||
3:20 PM | Borrowing Strength from Historical Control Data in Bayesian Trials — Xue Lin, U.S. Food and Drug Administration ; Boguang Zhen, U.S. Food and Drug Administration | ||
3:45 PM | Floor Discussion |
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