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Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
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Activity Details

350 Tue, 8/5/2014, 10:30 AM - 12:20 PM CC-Exhibit Hall B2
Contributed Oral Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Daniel S. Cooley, Colorado State University   
1: Clinical Trial Enrollment Modeling with Random Staggered Site Start-Up Times Steven Southwick, Quintiles ; Bradley Ferguson, Quintiles ; Valerii Fedorov, Quintiles ; Vladimir Anisimov, Quintiles
2: A Simple Approach for Sample Size Calculation for Comparing Two Concordance Correlation Coefficients Estimated on the Same Subjects Hung-Mo Lin, Mount Sinai School of Medicine ; John Michael Williamson, CDC
3: Sensitivity Analysis of Missing Longitudinal Patient-Reported Outcomes in Asthma Tulin Shekar, Merck
5: Some Considerations on Adaptive Design with a Long-Term Assessment of Primary Efficacy Endpoint Junliang Chen, Grifols Therapeutics ; Chunqin Deng, Grifols Therapeutics ; Jaume Ayguasanosa, Instituto Grifols S.A. ; Sandra Camprubi, Instituto Grifols S.A.
6: Fisher-Yates Normalization for Questionnaire Data Birol Emir, Pfizer ; Javier Cabrera, Rutgers University
7: Point-to-Consider of Design Considerations on Consistency of Treatment Effect Across Regions in Multiregional Clinical Trials (MRCT) Huei Wang, Amgen ; Kefei Zhou, Amgen ; Jenny Song, Amgen
8: Logistic Regression Likelihood Ratio Test Analysis and Harnessing Graphics to Explore Safety Data in the Vaccine Adverse Event Report System (VAERS) Kijoeng Nam, FDA ; Estelle Russek-Cohen, FDA/CBER
9: How to Increase Randomized Control Trials (RCTs) Sensitivity: Using Marginal Mean vs. Cutpoints Derived from Intra-Individual Distributions Hiroko Dodge, Oregon Health & Science University ; Jian Zhu, University of Michigan ; Nora Mattek , Oregon Health & Science University ; Judith Kornfeld, Oregon Health & Science University ; Jeffrey Kaye, Oregon Health & Science University
10: Curtailed Two-Stage Design for Comparing Two Binomial Proportions in Phase II Clinical Trials Chia-Min Chen, Nanhua University
11: Sensitivity Analysis for Stochastic Networks with a High-Dimensional Parameter Space Weilong Hu, University of Massachusetts, Amherst ; Yannis Pantazis, University of Massachusetts, Amherst ; Markos Katsoulakis, University of Massachusetts, Amherst ; Dionisios Vlachos, University of Delaware
12: Defining Geographic Regions with a Data Mining Approach Ziliang Li, Merck
13: Exposure Adjusted Continual Reassessment Method (EACRM) for Phase I Oncology Dose-Finding Studies Xin Qi, Michigan State University ; Wijith Munasinghe, AbbVie ; Balakrishna Hosmane, AbbVie ; Yi-Lin Chiu, AbbVie ; Kyle Holen, AbbVie
14: Graphical and Numerical Methods Using Concentration-Response Profiles in Drug Discovery Patrick Edmonds, University of Kansas Medical Center ; Jo A. Wick, University of Kansas Medical Center ; G. Sitta Sittampalam, NIH/NCATS ; Ajit Jadhav, NIH/NCATS
15: A Flexible and Super-Fast Quantile Regression Solver Youlan Rao, Parexel ; Yonggang Yao, SAS Institute
16: Efficacy Analyses with an Application in Vaccine Studies with Stratified Design Shu-Chih Su, Merck ; Frank Liu, Merck
17: A Prospective Evaluation of Regional Effects in a Randomized Double-Blind Phase III Trial Xin Huang, Amgen ; Lynn Navale, Amgen
18: Comparison of a Simple Bayesian Decision-Theoretic Design for Dose-Finding Trials with Traditional 3-Plus-3 Method Lynn Eudey, California State University, East Bay ; Shenghua Kelly Fan, California State University, East Bay ; Tianyao Lu, California State University, East Bay
19: Accounting for Pre-Treatment Dropout Using Inverse Probability Weighting: Application to a Phase III Clinical Trial in Multiple Sclerosis Stephen Lake, Genzyme ; Amy Cinar, Genzyme ; Jeff Palmer, Genzyme ; David Margolin, Genzyme ; Michael Panzara, Genzyme
20: Biosimilar Data Analysis Based on Time-Course of the Clinical Outcomes Song Wang, PPD
21: Methods to Minimize Power Loss at Interim Futility Analyses and Final Analyses Due to Violations of Sample Size Assumptions in Clinical Trials with Survival Endpoints Joseph Adair, PPD
22: A Bayesian Adaptive Design for Cancer Phase I Trials Using a Flexible Range of Doses Galen Cook-Wiens, Cedars-Sinai Medical Center ; Mourad Tighiouart, Cedars-Sinai Medical Center ; Andre Rogatko, Cedars-Sinai Medical Center
23: Using a Pattern of Response Outcome for a Pilot Off-on-Off Crossover Design Jonathan D. Mahnken, University of Kansas Medical Center ; Russell H. Swerdlow, University of Kansas Medical Center
24: Modified Toxicity Probability Interval (TPI) Design for Phase I Oncology Trials: A Case Study Tony Jiang, Amgen
25: Recommendations for the Methodology and Visualization Techniques to Be Used in the Assessment of Benefit and Risk of Medicines: Findings from IMI Protect Consortium Gerald Downey, Amgen ; Diana Hughes, Pfizer
26: Sample Size and Data Monitoring for Clinical Trials with Extremely Low Incidence Rate Shih-Ting Chiu, Duke University ; Shein-Chung Chow, Duke University School of Medicine
27: Metrics for Safety Assessment in Clinical Trials Ying Zhou, Amgen ; Qi Jiang, Amgen ; Chunlei Ke, Amgen ; Seta Shahin, Amgen ; Steven Snapinn, Amgen

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