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359
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Tue, 7/31/2018,
10:30 AM -
12:20 PM
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CC-West Hall B
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Contributed Poster Presentations: Biopharmacutical Section — Contributed Poster Presentations
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Biopharmaceutical Section
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Chair(s): Paul McNicholas, McMaster University
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26:
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Assessing Reproducibility When Making Mid-Course Changes in Clinical Trials Based on External Data
Yingqi Shi, Johnson & Johnson-Janssen R&D; Grace Gao, Janssen R&D; Keith Karcher, Janssen R&D
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27:
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Methods to Handle Missing Outcome Data in Studies of Acute Illnesses Followed by Recovery
Dashiell Fellini Young-Saver, University of California, Los Angeles; Jeffrey Gornbein, University of California, Los Angeles; Sidney Starkman, University of California, Los Angeles; Jeffrey Lawrence Saver, University of California, Los Angeles
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28:
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Sample Size and Assurance Probability Calculation in Multi-Regional Clinical Trials
Zuoshun Zhang, Celgene Corporation
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29:
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Nonparametric Survival Analysis with Delayed Treatment Effect
Kijoeng Nam, Merck; Nicholas Henderson, Johns Hopkins University; Dai Feng, Merck
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30:
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A Bayesian Adaptive Model-Based Approach for Dose Selection in a FGF21 2nd Gen Phase 1 Study
Yuping Dong
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31:
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Defining a More Powerful Endpoint in a Longitudinal Trial with information of correlation coefficient
Ruji Yao; qing li, merck; wen-chi wu, merck
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32:
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A Bayesian-Frequentist Hybrid Sequential Design of a Single-Arm Study with Binary Outcome and Its Shiny App
Yansong Cheng, Alkermes
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33:
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Applications of Neural Net Models to Identify Placebo Responders in Clinical Trials
Mikhail Dmitrienko, Blue Valley North High School
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35:
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Clinical Trial Design Comparison with Covariate-Adjusted and Response Adaptive Randomization
Wei Qiao, The University of Texas M.D. Anderson; Xuelin Huang, University of Texas MD Anderson Cancer Center; Jing Ning, The University of Texas M.D. Anderson Cancer Center
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36:
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Methods for Combining Controlled and Uncontrolled Clinical Trials
Shuyan Sabrina Wan, Merck Research Lab; Yuan Feng, North Carolina State University; Hong Liu, Merck; Kenneth Koury, Pfizer
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37:
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Using Wearable Devices to Quantify Modulation of Circadian Rhythms
Dmitri Volfson, Pfizer; Cici Bauer, Pfizer, Inc; Francois Gaudreault, Biogen Inc.; Cheng Chang, Pfizer; Arthur Simen, Takeda Inc; Travis Wager, Pfizer; Eve Pickering, Pfizer
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38:
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Sample Size Calculation for a Pilot Study
Danielle Sim, UCLA; Chi-Hong Tseng, UCLA
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39:
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Use of Propensity Score and Disease Risk Score for Multiple Treatments with Time-To-Event Outcome
DI ZHANG, University of Pittsburgh; Jessica Kim, Division of Biometrics VII/Office of Biostatistics/CDER, FDA
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40:
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Endpoint and Time-To-Event Analyzes in Interim Clinical Trial Reports
Scott Diegel, University of Wisconsin-Madison; Ryan Zea, University of Wisconsin-Madison; Melissa Schultz, University of Wisconsin-Madison
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41:
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Univariate, Multivariate and Model-Based Prediction on Truncated Continuous Data with Shiny/R
Qianqiu Li, Janssen Research & Development
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42:
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A Bayesian Adaptive Design in Cancer Phase I/II Trials with Drug Combinations Using Escalation with Overdose Control (EWOC) and Adaptive Randomization
Sungjin Kim, Cedars-Sinai Medical Center; José L. Jiménez, Politecnico di Torino; Mourad Tighiouart, Cedars-Sinai Medical Center
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43:
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An Evaluation of Statistical Methods with Missing Data in Small Clinical Trials
Takayuki Abe, Yokohama City University, School of Data Science; Kazuhito Shiosakai, Daiichi Sankyo Co., Ltd.; Manabu Iwasaki, Yokohama City University, School of Data Science
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44:
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Response to Regulatory Issues in an Adaptive Medical Device Study
Jill Stankowski, ICON Plc
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45:
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A Comparison of MI and MMRM for Treatment of Missing Data
Lori Davis, QST Consultations
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46:
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Evaluating the Impact of Missing Data Mechanisms and Imputation Methods in Analysis of Bivariate Longitudinal Data with Subject Effect
Yonggang Zhao, Skyview Research; Qianqiu Li, Johnson & Johnson
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47:
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Some Statistical Issues Regarding to Assay Sensitivity in "Hybrid TQT" Study
Dalong Huang, FDA/CDER; Janell Chen, FDA/CDER; Yi Tsong, CDER, FDA; Qianyu Dang, FDA/CDER
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48:
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Sample Size in Adaptive Design with Treatment Selection
Zejiang Yang, Syneos Health
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49:
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Sequential Parallel Comparison Design with Binary and Time-to-Event Outcomes
Rachel Silverman, Merck & Co.; Anastasia Ivanova, University of North Carolina, Chapel Hill; Jason P Fine, University of North Carolina at Chapel Hill
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50:
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Power and Type I Error Assessments on Methods to Size Binomial Endpoints Under Unequal Randomization Ratios
Rong Wang, Pfizer Inc
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51:
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The Modified Toxicity Probability Interval Design with Consideration of Late Onset Toxicities
Xiaohui Huang, Gilead Sciences; Guan Xing, Gilead Sciences
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52:
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Event Projection for Blinded Studies
Guan Xing; Xiaohui Huang, Gilead Sciences
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53:
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A Novel Approach of Using Prior Elicitation Information to Direct Design of a Phase 2 POC Study
Geng Chen, GlaxoSmithKline; Jonathan Haddad, Glaxosmithkline
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54:
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Statistical Methods to Estimate Diagnostic Testing Accuracy of ULTE4 to Determine Aspirin Intolerance in Asthma Using Meta-Analysis Data
Nan Zhang, Mayo Clinic; John Hagan, Mayo Clinic; Matthew Rank, Mayo Clinic; Yu-Hui Chang, Mayo Clinic; Rohit Divekar, Mayo Clinic; Erin O'Brien, Mayo Clinic; Gerald Volcheck, Mayo Clinic; Devyani Lal, Mayo Clinic; Patricia Erwin, Mayo Clinic; Harry Teaford, Mayo Clinic; Hirohito Kita, Mayo Clinic; Tanya Laidlaw, Harvard Medical school; Christina Hagan, Baylor College of Medicine
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55:
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Non-Inferiority Margins in Superiority/Non-Inferiority Seamless Clinical Trials
Ellen Gurary, Boston University; Joe Massaro, Boston University
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56:
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Determination of Optimal Cut-Off Points for Biomarkers in Oncology Research
Shu-Pang Huang, Bristol-Myers Squibb Co.; Tian Chen, Bristol-Myers Squibb Co.; Ye Feng, Bristol-Myers Squibb Co.; Ming Zhou, Bristol-Myers Squibb Company; Ramachandran Suresh, Bristol-Myers Squibb Co.
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57:
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Using Tradition to Guide Non-Traditional Decisions in Phase 1 Clinical Trials
Paul Frankel, City of Hope
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58:
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PFS2: Event or Censor?
Dongmei Lan, ICON Plc; JIll Stankowski, ICON Plc
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60:
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Seeking Optimal Oral Cancer Drug Combinations
Ricardo Palafox, CSU Fullerton; Jessica Jaynes , CSU Fullerton
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61:
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Safety Data Presentations in USPIs: Methodological Considerations
Adam Boyd, Array BioPharma Inc; Michael Pickard, Array BioPharma Inc
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63:
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A Novel Outlier Test for Plate Based Dilution Bioassay
Jerry W. Lewis, Biogen Idec
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65:
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Missing data imputation in confirmatory clinical trials - a comparison case study
Yue Song, PAREXEL; Sophie (Xiongfei) Wang, PAREXEL
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