Sessions Were Renumbered as of May 19.
Legend:
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
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
