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Sunday, 08/01/2010
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The OMOP Project: A Large-Scale Evaluation of Drug Safety Surveillance Algorithms in Longitudinal Databases
David Madigan, Columbia University; Patrick Ryan, GlaxoSmithKline
4:05 PM
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Follow-Up of Subjects in Event Rates for Periodic Safety Monitoring Reports in Open Enrollment Clinical Trials
Maria Carola Alfaro, Boston Scientific Corporation
4:05 PM
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Sequential Analytic Methods for Prospective Drug Safety Surveillance
Lingling Li, Harvard Medical School/Harvard Pilgrim Health Care Institute
4:30 PM
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Using Bayesian Adaptive Designs for FDA Event Safety Studies
Jason Connor, Berry Consultants, LLC; Scott Berry, Berry Consultants, LLC; Donald Arthur Berry, MD Anderson Cancer Center
4:45 PM
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Empirical Comparison of Different Drug Safety Signal Detection Assays Based on Incident User Designs
Maurice Alan Brookhart, Brigham and Women's Hospital/Harvard Medical School; Eric Brinsfield, SAS Institute
4:55 PM
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Monday, 08/02/2010
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Globalization of Biostatistics: The Development Treatments and Preventative Products for Infectious Diseases
Tammy Massie, FDA/CBER
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Applications of the Truncated Robust Distance (TRD) Method on Large Aggregated Clinical Lab Data for Safety Monitoring and Assessment
Daniel Parks, GlaxoSmithKline; Xiwu Lin, GlaxoSmithKline; Lei Zhu, GlaxoSmithKline; Jie Cheng, GlaxoSmithKline; Kwan Lee, GlaxoSmithKline
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The Use of Contrast-Enhancing Lesions to Predict Imminent Relapse: Validating Cutter's Rule
Charity Johanna Morgan, The University of Alabama at Birmingham; Ashutosh Ranjan, The University of Alabama at Birmingham; Gary Cutter, University of Alabama at Birmingham
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Competing Risks Methods in Safety Analysis of Oncology Clinical Trials
Sofia Paul, Novartis Pharmaceuticals Corporation; Bingqing Zhou, The University of North Carolina at Chapel Hill; Samit Hirawat, Novartis Pharma; Glen Laird, Novartis Pharmaceuticals Corporation
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Globalization of Biostatistics: The Development Treatments and Preventative Products for Infectious Diseases Including Applications in H1N1, Travelers Diarrhea, and/or Malaria
Tammy Massie, FDA/CBER
9:55 AM
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Performance Characteristic of Sequential Probability Ratio Test (SPRT) for Data Monitoring Committee (DMC) Review in Drug-Eluting Stent Clinical Trials
Yun Lu, Boston Scientific Corporation; Huyuan Yang, Boston Scientific Corporation
3:05 PM
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Tuesday, 08/03/2010
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Meta-Analysis for Rare Adverse Event Data from Clinical Trials
Brenda Crowe, Eli Lilly and Company
10:35 AM
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Real-Time Safety Assessment: A Sponsor's Approach on Tool Development to Facilitate the Assessment
Christy Chuang-Stein, Pfizer Inc.; Craig Hartford, Pfizer Inc.; David M. Jones, Pfizer Inc.; Janice Lamb, Pfizer Inc.
10:55 AM
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Prospective Safety Analysis Plans: Critical Elements and Principles
George Rochester, FDA
11:35 AM
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Crime Mapping in The Netherlands
Elke Amelie Moons, Statistics Netherlands; Leanne Houben, Statistics Netherlands
2:50 PM
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Collapsing Ordered Categories for Detecting the Emergence of Toxic Chemical by Using Dose-Response Curves
Takashi Yanagawa, Kurume University
2:55 PM
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Wednesday, 08/04/2010
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Are Some Vehicle Colors Safer Than Others?
Peter William Hovey, University of Dayton/Air Force Academy; Deogratias Eustace, University of Dayton; Stephen Owusu-Ansah, University of Dayton
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Bias Correction for Rare Events in Self-Controlled Case Series Design of Vaccine Safety
Chan Zeng, Kaiser Permanente Colorado; Jason M. Glanz, Kaiser Permanente Colorado; Sophia R. Newcomer, Kaiser Permanente Colorado; Stanley Xu, Kaiser Permanente Colorado
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The Role of Statistics and Opportunities for Statisticians in Active Drug Safety Surveillance
Patrick Ryan, GlaxoSmithKline
9:05 AM
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A Dose-Finding Method in Joint Modeling of Efficacy and Safety: An Extension of the MCP-Mod Method
Aiyang Tao, Novartis; Yong Lin, University of Medicine and Dentistry of New Jersey; Jose Carlos Pinheiro, Johnson & Johnson; Weichung J. Shih, University of Medicine and Dentistry of New Jersey
11:35 AM
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Comparing Proportions of Extremely Rare Events of Uncertain Status with Applications to Vaccine Safety Studies
Hongyuan Cao, The University of North Carolina at Chapel Hill; Lisa M. LaVange, The University of North Carolina at Chapel Hill; Joseph Heyse, Merck Research Laboratories; Michael Kosorok, The University of North Carolina at Chapel Hill
11:35 AM
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Bayesian Applications in Drug Safety Evaluation
Amy Xia, Amgen Inc.
2:55 PM
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Medical Device Software Safety, Validation, Verification, and Effectiveness
Carolyn Carroll, STAT TECH, Inc.
3:05 PM
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Thursday, 08/05/2010
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Comparison of Hauer's EB method, Causal Inference Methods, and a Full Bayesian Method for Estimating Countermeasure Effectiveness in Transportation Safety Studies
Courtney Bokenkroger, Midwest Research Institute
8:35 AM
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Modeling Teen Driving Behavior
Feng Guo, Virginia Tech
8:55 AM
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A Bayesian Self-Controlled Case Series Method for Large-Scale Longitudinal Data in Drug Safety Surveillance
Shawn Evelyn Simpson, Columbia University; David Madigan, Columbia University
9:05 AM
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Bayesian Hierarchical Models for Detecting Safety Signals in Clinical Trials
Haijun Ma, Amgen Inc.; Amy Xia, Amgen Inc.; Bradley P. Carlin, University of Minnesota
10:35 AM
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Sequential Conditional Tests for an Increasing Trend in a Sequence of Binomial Proportions with Applications to Safety Signal Detection
Jie Chen, Abbott Laboratories
10:55 AM
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Comparison of Different Choices of Baseline Values in Parallel Thorough QTc Studies
Qianyu Dang, FDA; Joanne Zhang, FDA
11:15 AM
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