JSM 2015 Preliminary Program
Legend: Washington State Convention Center = CC, Sheraton Seattle = S, Grand Hyatt = GH and The Conference Center = TCC
* = applied session ! = JSM meeting theme
* = applied session ! = JSM meeting theme
Activity Details
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| 372 | Tue, 8/11/2015, 10:30 AM - 12:20 PM | CC-4B | |
| Contributed Oral Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations | |||
| Biopharmaceutical Section | |||
| Chair(s): Lan Xue, Oregon State University | |||
| 1: | Practical Approach to Missing Item Imputation in Asthma Quality-of-Life Questionnaire — Tulin Shekar, Merck | ||
| 2: | Optimal Designs for Multiregional Clinical Trials with Regional Consistency Requirement — Zhaoyang Teng, Takeda Pharmaceutical International Co. ; Mark Chang, AMAG Pharmaceuticals | ||
| 3: | Continuous Blinding Monitoring for Randomized Controlled Clinical Trials — Yufan Zhao, Incyte Corporation ; Yingqi Zhao, University of Wisconsin - Madison ; Kevin Hou, Incyte Corporation | ||
| 4: | Statistical Methods for MIMIC Assay Data — Robert D. Small, Sanofi Pasteur | ||
| 5: | Reducing Alpha Adjustment When Tests Are Structurally Correlated — Jonathan Siegel, Bayer HealthCare Pharmaceuticals | ||
| 6: | Improved Power for 2x2, 3x3, and 4x4 Crossover Trials with Baselines — Thomas Jemielita ; Mary Putt, University of Pennsylvania ; Devan Mehrotra, Merck | ||
| 7: | A Computational Procedure for Mean Kinetic Temperature Using Unequally Spaced Data — Amy B. Lock, USDA ; Christopher Tong, USDA | ||
| 8: | Network Meta-Analysis Combining Aggregated and Individual Patient Data — Anna Wiksten, Novartis Pharma AG ; Ekkehard Glimm, Novartis | ||
| 9: | Performance Evaluation of New Trial-Level Surrogacy Measures in Binary-Binary Endpoint Scenario in Clinical Trials — Yiyi Chu, The University of Texas Health Science Center ; Qian Shi, Mayo Clinic ; Daniel Sargent, Mayo Clinic | ||
| 10: | Hypothesis Testing of Covariate-Adaptive Randomized Clinical Trials with Survival Outcomes — Lu Wang, The University of Texas Health Science Center ; Hongjian Zhu, The University of Texas School of Public Health ; Jing Ning, MD Anderson Cancer Center | ||
| 11: | Bayesian Modeling and Prediction of Accrual in Multi-Regional Clinical Trials — Yi Deng, Emory University ; Xiaoxi Zhang, Pfizer Inc. ; Qi Long, Emory University | ||
| 13: | Unblinded Sample Size Re-Estimation and the Negative Binomial Model in Clinical Trials — Jerry Weaver, Novartis Pharmaceuticals ; Paul Gallo, Novartis Pharmaceuticals | ||
| 14: | Correlations of Patient-Reported Outcomes with PSA and Survival Endpoints in Prostate Cancer Patients — Xuemei Li, Janssen R&D | ||
| 15: | Using Simulations for Regulatory Decision-Making: How Many Simulations Do We Need to Run? — Paul Schuette, FDA/CDER | ||
| 16: | A Bayesian Approach for Designing Phase II Clinical Trials with Rare Tumor Types in Oncology — Santosh Sutradhar, Novartis Pharmaceuticals ; Satrajit Roychoudhury, Novartis Pharmaceuticals | ||
| 17: | Generalized Error Rates for Subgroup Analyses — Xiaolei Xun, Novartis ; Frank Bretz, Novartis ; Willi Maurer, Novartis | ||
| 18: | Sizing Clinical Trials When Comparing Two Interventions Using Two Time-to-Event Outcomes — Tomoyuki Sugimoto, Hirosaki University ; Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center ; Scott R. Evans, Harvard University ; Takashi Sozu, Kyoto University School of Public Health | ||
| 19: | Exact Statistical Tests for Comparing Tumor Incidence Trend in Transgenic Mouse Carcinogenicity Studies — Lei Shu, AbbVie ; Lanju Zhang, AbbVie ; Bo Yang, AbbVie | ||
| 20: | Evaluating Methods for Estimating a Treatment Effect During Treatment-Switching in Time-to-Event Clinical Trials — Carl Dicasoli, Bayer HealthCare Pharmaceuticals ; Martin Homering, Bayer HealthCare Pharmaceuticals ; Christian Kappeler, Bayer HealthCare Pharmaceuticals ; Harald Siedentop, Bayer HealthCare Pharmaceuticals ; Thomas Schmelter, Bayer HealthCare Pharmaceuticals ; Daniel Haverstock, Bayer HealthCare Pharmaceuticals | ||
| 21: | A Guidance of Using Meta-Analysis Method for Data with Rare Event — Yao Yu, AbbVie ; Yuanyuan Tang, AbbVie ; Qi Tang, AbbVie ; Shihua Wen, AbbVie | ||
| 22: | Evidence for Model-Based Dose Response for Biological Products for Rheumatoid Arthritis and Psoriasis — Anindita Banerjee, Pfizer Inc. ; Joseph Wu, Pfizer Inc. ; Bo Jin, Pfizer Inc. ; Steven Martin, Pfizer Inc. | ||
| 23: | Regularized Outcome Weighted Subgroup Identification for Differential Treatment Effects — Yaoyao Xu, AbbVie ; Menggang Yu, University of Wisconsin - Madison ; Yingqi Zhao, University of Wisconsin - Madison ; Quefeng Li, Princeton University ; Sijian Wang, University of Wisconsin - Madison ; Jun Shao, University of Wisconsin - Madison | ||
| 24: | Exact Inference for 3-Treatment, 3-Period, 6-Sequence Crossover Design — Ching-Ray Yu, Pfizer Inc. ; Michael Riggs, Pfizer Inc. ; Sam Weerahandi, Pfizer Inc. | ||
| 25: | Randomness and Variability in Restricted Randomization — Hui Shao ; William F. Rosenberger, George Mason University | ||
| 26: | An Adaptive Method for the Normalization of MicroRNA Array Data — Qing Zhao ; Yuda Zhu, Genentech, Inc. ; Karin Staflin, Genentech, Inc. | ||
| 27: | Assessing Agreement: A Graphical Approach — Paul Hshieh, CBER/FDA ; Tie-Hua Ng, FDA/CBER | ||
| 28: | Graphical Approaches to Evaluate Liver Safety Data in Clinical Trials — Melissa Schultz, University of Wisconsin ; Scott Diegel, University of Wisconsin | ||
| 29: | Statistical Assessment of Clinical Trials with Discordant Pairs of Observations — James Lee, Daiichi Sankyo Pharma Development ; Dar Shong Hwang, B.R.S.I. ; Chyi-Hung Hsu, Janssen R&D | ||
| 31: | Agreement on the Interpretations of Beta-Amyloid Images — Jonathan Mahnken, The University of Kansas Medical Center ; Alvin Beltramo, The University of Kansas Medical Center | ||
| 32: | Extending Logistic Regression Likelihood Ratio Test Analysis to Detect Signals of Vaccine-Vaccine Interactions in Vaccine Safety Surveillance — Kijoeng Nam, CBER/FDA ; Nicholas C. Henderson, University of Wisconsin - Madison ; Patricia Rohan, CBER/FDA ; Emily Jane Woo, CBER/FDA ; Estelle Russek-Cohen, FDA | ||
| 33: | Blinded Sample Size Recalculation for Survival Data — Kentaro Sakamaki, Yokohama City University | ||
| 34: | Bayesian Isotonic Regression Dose-Response — Wen Li, Accenture Accelerated R&D Services ; Jeffrey A. Davidson, Accenture Accelerated R&D Services ; Haoda Fu, Eli Lilly and Company | ||
| 35: | Bayesian-Commensurate Approach for Safety Assessment in Clinical Studies with Count Outcomes — Wei-Chen Chen, FDA ; Judy Li, FDA ; John Scott, FDA ; Paul Mintz, FDA | ||
| 36: | Hierarchical Bayesian Models for Understanding the Pharmacokinetics and Pharmacodynamics of Lorenzo's Oil — Cynthia Basu, University of Minnesota ; Mariam Ahmed, University of Minnesota ; James C. Cloyd, University of Minnesota ; Richard C. Brundage, University of Minnesota ; Bradley P. Carlin, University of Minnesota | ||
| 37: | Construction of Tolerance Interval Based on Small Data Sets — Yuanyuan Duan, AbbVie ; Lanju Zhang, AbbVie ; Jorge Quiroz, AbbVie Pharmaceutical Research & Development | ||
| 38: | Modern Ideas of Better DMC Report — Yao Yao, Axio Research ; David Kerr, Axio Research ; Tingting Li, Axio Research ; Kent Koprowicz, Axio Research | ||
| 39: | Application of a Class of Copula-Type Models in Early-Phase Dose Drug Combination Trials Using Conditional Escalation with Overdose Control — Galen Cook-Wiens, Cedars Sinai Medical Center ; Mourad Tighiouart, Cedars Sinai Medical Center ; Andre Rogatko, Cedars Sinai Medical Center | ||
| 40: | A Simulation Study Using Inverse Probability Weighting to Adjust for Multiple Types of Bias in Observational Studies — Diqiong Xie, FDA | ||
| 41: | A Case Study on Practical Patient-Level Benefit-Risk Assessment in a Clinical Trial — Bo Fu, AbbVie ; Shihua Wen, AbbVie | ||
| 42: | Shortcomings of the CONSORT 2010 Statement in the Reporting of Adaptive Trials — Steven A. Julious, University of Sheffield ; Munyaradzi Dimairo, University of Sheffield ; Abigail Stevely, University of Sheffield ; Susan Todd, University of Reading | ||
| 43: | Predicting Survival Probability in Clinical Trials Beyond Follow-Up Periods — Jerry Cheng, Rutgers University ; John Kostis, Rutgers University ; Javier Cabrera, Rutgers University | ||
| 44: | A Bayesian Meta-Analysis Method for Estimating Risk Difference of Rare Events — Qi Tang ; Yuanyuan Tang, AbbVie ; Yao Yu, AbbVie ; Shihua Wen, AbbVie | ||
| 45: | Dose-Finding for Drug Combination in Early Cancer Phase I Trials Using Conditional Continual Reassessment Method — Quanlin Li ; Mourad Tighiouart, Cedars Sinai Medical Center | ||
| 46: | Dose-Finding for Drug Combination in Early Cancer Phase I Trials in the Presence of a Baseline Binary Covariate Using Conditional Escalation with Overdose Control — Sungjin Kim, Cedars Sinai Medical Center ; Mourad Tighiouart, Cedars Sinai Medical Center | ||
| 47: | More Balanced Treatment Allocation When Randomization by Center — Ruji Yao ; Norman Ying Yao, Miller Institute for Basic Research in Science | ||
| 48: | Identification of Stably Expressed Genes from Arabidopsis RNA-Seq Data — Bin Zhuo ; Yanming Di, Oregon State University ; Sarah Emerson, Oregon State University | ||
| 49: | A Novel Method of Subgroup Identification by Using Virtual Twins and GUIDE (VG) for Development of Personalized Medicines — Jia Jia ; Qi Tang, AbbVie ; Wangang Xie, AbbVie ; Richard Rode, AbbVie | ||
| 50: | Statistical Analysis on Models Defined by Differential Equations — Hongyuan Wang ; David Allen, University of Kentucky | ||
| 51: | Retrospective Meta-Analyses for Phase I Studies — Sarah Zohar, INSERM UMR 1138 ; Anand Vidyashankar, George Mason University ; Jie Xu, George Mason University | ||
| 52: | Data-Driven Prior Distributions for a Phase II COPD Dose-Finding Clinical Trial — Shuyen Ho, GSK ; Steven Novick, GlaxoSmithKline | ||
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