Keyword Search
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
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Keyword Search Criteria: safety returned 33 record(s)
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Monday, 08/01/2016
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Detecting Vaccine-Vaccine Interactions in Large Spontaneous Reporting Databases
Kijoeng Nam, Merck; Nicholas Henderson, The Johns Hopkins University
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Web-Based Application of Likelihood Ratio Test (LRT)--Based Method for Signal Detection in OpenFDA
Yuyi Hsu; Jyoti Zalkikar, FDA; Ram Tiwari, FDA/CDER/OT/OB; Jay Levine, FDA
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Confounder Adjustments by Propensity Score and Disease Risk Score in the Early Stage of Post-Marketing Drug Safety Surveillance
Tae Hyun Jung, Yale University; Jessica Kim , FDA
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Crash-Safety Ratings and the True Assessment of Injuries by Vehicle
Cody Philips, Miami University
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Time-Dependent Clustering Tells a Danger on the Road
Eunice Kim
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Crash-Safety Ratings and the True Assessment of Injuries by Vehicle
Cody Philips, Miami University
8:40 AM
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Time-Dependent Clustering Tells a Danger on the Road
Eunice Kim
8:55 AM
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Effect of Differential Discontinuations Across Treatment Arms on Survival Estimates in Randomized Clinical Trials
Shanti Gomatam, FDA
9:35 AM
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Two-Stage Statistical Evaluation of Cardiovascular Safety Assessment of Diabetes Drugs
Raymond Lam, Merck; Shailaja Suryawanshi, Merck
11:20 AM
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ASA Biopharm's Safety Monitoring Subteam: Survey of Statisticians, Thought Leaders, and Regulatory Guidance
Mike Wright Colopy, UCB Bioscience; Susan Duke, AbbVie
2:05 PM
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Safety-Monitoring Methodology in the Premarketing Setting
Melvin Munsaka, Takeda Development Center
2:25 PM
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Statistical Considerations for Cardiovascular Outcome Trials in Patients with T2DM
Maria Matilde Sanchez-Kam, Arena Pharmaceuticals
2:45 PM
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Wednesday, 08/03/2016
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The Naturalistic Driving Study and Statistical Modeling Challenges
Feng Guo, Virginia Tech
8:35 AM
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On Bayes and Frequentist Meta-Analyses
Hal Li, Merck Research Laboratories; William William Wang, Merck Research Laboratories
9:05 AM
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Causal Inference Methods in Traffic Safety Research
Fan Li, Duke University
9:25 AM
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Generating Policy-Relevant Statistical Evidence in Sequentially Monitored Vaccine and Drug Safety Evaluations Using Electronic Health Record Data
Jennifer Clark Nelson, Group Health Research Institute; Andrea J. Cook , Group Health Research Institute; Robert Wellman, Group Health Research Institute; Ram Tiwari, FDA/CDER/OT/OB; Michael Nguyen, FDA; Estelle Russek-Cohen, FDA; Tracey Marsh, University of Washington; Azadeh Shoaibi, FDA; Denise Boudreau, Group Health Research Institute
9:25 AM
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Bayesian Design of Phase II Noninferiority (NI) Safety Clinical Trial
Lu-May Chiang, Novartis Pharma; David Ohlssen, Novartis; Dong Xi, Novartis
11:20 AM
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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
11:35 AM
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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
12:05 PM
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Aviation Safety: Analysis of Historical Accident Data
Nastaran Coleman, Federal Aviation Administration
3:20 PM
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Improved Designs and Analyses of Safety and Efficacy in Immuno-Oncology
Bo Huang, Pfizer; Margarida Geraldes, Pfizer
3:25 PM
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Thursday, 08/04/2016
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Identifying Risk Factors for Interstate Crashes Using Spatial Statistics
Kaitlin Gibson, Brigham Young University; Matthew J. Heaton, Brigham Young University
8:35 AM
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Outside the Closed Door: Industry Statisticians Discuss the DMC Process
Paul Gallo, Novartis; Walt Offen, AbbVie; Markus Abt, Roche/Genentech; Gordon Sun, BioMarin; Gary Aras, Amgen
8:35 AM
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Evaluation of Logistic and Cox Regression Models Using Simulated Survival Data and Clinical Practice Research Datalink
Jessica Kim , FDA; Chenyi Pan, University of Virginia; Clara Y. Kim, FDA/CDER; Esther Zhou, FDA/CDER
9:20 AM
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A Class of Semiparametric Models in Analysis of Adverse Events in Drug Safety
Richard Entsuah, Merck
10:35 AM
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