JSM 2011 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Activity Details


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

2011 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.