Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
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| 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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