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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

548 * Wed, 8/3/2016, 10:30 AM - 12:20 PM CC-W187c
Clinical Trial Monitoring — Contributed Papers
Biopharmaceutical Section
Chair(s): Theodore Lystig, Medtronic
10:35 AM The Three Pillars of a Successful Data Monitoring Committee Organizational Meeting and Interim Monitoring of a Randomized Clinical Trial and the Eventual Impact on Public Health Navneet Ram Hakhu, Axio Research
10:50 AM Group-Sequential Clinical Trials for Comparing Two Interventions Using Two Time-to-Event Outcomes Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center ; Tomoyuki Sugimoto, Hirosaki University ; Koko Asakura, National Cerebral and Cardiovascular Center ; Scott Evans, Harvard
11:05 AM Enhanced Conditional Power and Predictive Power Using Auxiliary Information Libo Sun, Janssen R&D ; Ying Wan, Janssen R&D
11:20 AM Best Practices for Reporting Adverse Event Data to Data-Monitoring Committees Hengrui Sun, The University of North Carolina at Chapel Hill ; Kwanhye Jung, The University of North Carolina at Chapel Hill ; Sonia Davis, The University of North Carolina at Chapel Hill
11:35 AM Statistical Issues for Safety Monitoring of Recurrent Adverse Events in Clinical Trials LiAn Lin, Merck Research Laboratories ; Greg Ball, Merck Research Laboratories ; William William Wang, Merck Research Laboratories
11:50 AM Modeling Events and Early Terminations to Predict John Johnson, PPD
12:05 PM Collection of Adverse Events Data for the Supplemental Indications in Cancer Clinical Trials: Is It Needed? Sirisha Mushti, FDA ; Huanyu Chen, FDA ; Yun Wang, FDA ; Rajeshwari Sridhara, FDA
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