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Monday, 08/05/2013
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Tools for Presenting Examples of Sampling Distributions and Hypothesis Testing
Mark C. Fulcomer, Restat Systems, Inc.; S. David Kriska, Walden University; Marcia M. Sass, UMDNJ
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Assessing Models of RNA-Sequencing Data
Yanming Di, Oregon State University; Gu Mi, Oregon State University; Sarah Emerson, Oregon State University; Daniel Schafer, Oregon State University
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Sample Size Calculations for Treatment and Biomarker Interactions
Scarlett Kazimer
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A Fiducial Approach to Sparse Covariance Estimation
Wen Shi, UNC; Jan Hannig, UNC-Chapel Hill
9:35 AM
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Trial Duration and Sample Size Trade-Off When There Are Subgroups with Different Expected Treatment Effects
Kyle D. Rudser, University of Minnesota; Edward Bendert, Statistics Collaborative; Joseph S. Koopmeiners, University of Minnesota
9:35 AM
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An Alternative Sample Size Method for Training Survival Risk Predictors in High Dimensions
Kevin Dobbin, University of Georgia; Xiao Song, University of Georgia
10:35 AM
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A Two-Stage Bayesian Design with Sample-Size Re-Estimation and Subgroup Analysis for Phase II Binary Response Trials
Wei Zhong, Genentech Inc.; Joseph S. Koopmeiners, University of Minnesota; Bradley P. Carlin, University of Minnesota
10:50 AM
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Quantitative Considerations for Enrichment Clinical Trial Implementation: Marker Prevalence, Effect Size, Diagnostic Assay Performance, Sample Size, and Beyond
Ray Liu, Columbia
10:55 AM
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Objective Calibration of the Bayesian Continual Reassessment Method
Ken Cheung, Columbia University; Shing M. Lee, Columbia University
11:00 AM
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Sample-Size Determination for Equivalence Trial of Continuous Responses
Yu-Wei Chang, Temple University; Xiaoyu Dong, FDA; Yi Tsong, FDA
11:50 AM
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Sample Size Considerations When Using Two Time-to-Event Outcomes for Comparing Two Interventions in Clinical Trials
Toshimitsu Hamasaki, Osaka University Graduate School of Medicine; Tomoyuki Sugimoto, Hirosaki University Graduate School of Science and Technology; Takashi Sozu, Kyoto University School of Public Health; Scott Evans, Haravard University School of Public Health
2:35 PM
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Properties of Slope Estimators Associated with Random Slope Models
Brian Gray, U.S. Geological Survey; Vyacheslav Lyubchich, University of Waterloo, Canada; Yulia R. Gel, University of Waterloo
3:25 PM
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Missing Data Sensitivity Analyses with Small Sample Sizes
Susan Huyck, Merck
3:35 PM
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Tuesday, 08/06/2013
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Uncertainty in Pilot Parameter Estimates: A Comparison of Methods to Size Full Trials
Elizabeth Handorf, Fox Chase Cancer Center; Eric A. Ross, Fox Chase Cancer Center
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Variance Estimation of the Design Effect
Alberto Padilla
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Model-Based Classifications of High-Throughput Data Review, Design, and Application to a Cancer Clinical Study
AC Cambon, Department of Bioinformatics and Biostatistics, University of Louisville; Shesh Nath Rai, University of Louisville
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Bayesian Sample-Size Determination for Studies with Censored Cost-Effectiveness
Daniel Beavers, Wake Forest School of Medicine; James D. Stamey, Baylor University
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High-Dimensional Learning for Ordinal and Multiclass Data
Xingye Qiao, Binghamton University
8:35 AM
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Two-Sample Test for Differences in Survival at a Fixed Time Point with Small Sample Sizes
Michael Fay, National Institute of Allergy and Infectious Diseases; Michael Proschan, NIH; Erica H. Brittain, National Institute of Allergy and Infectious Diseases
9:00 AM
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Single-Arm Phase IIa Oncology Clinical Trials with Sample Size Adaptation
Bob Zhong, Johnson & Johnson
9:10 AM
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On Sample Size for Nonparametric Regression and Partial Linear Models
Li-Shan Huang, National Tsing Hua University; Hsiao-Hsian Gao, National Tsing Hua University
9:15 AM
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Applying Weighted GEE for Sample-Size Estimation in Repeated Measurement Studies with Dropout
Anna Sun, UMBC
9:35 AM
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Within Subject Nested Clinical Trial Laboratory Data:Sample Size, Components of Variance and Cost
Borko Jovanovic, Northwestern Univ-Feinberg School of Medicine; Hariharan Subramanian, Northwestern University; Irene Helenowski, Northwestern University ; Alfred Rademaker, Northwestern University; Angela Fought, Northwestern University; Hemant Roy, Northwestern University ; Vadim Backman , Northwestern University
10:35 AM
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Misspecification of Event Rates and Sample Size Re-Evaluations in Noninferiority Trials
Hwasoon Kim, University of Alabama, Birmingham; Jeff M Szychowski, University of Alabama at Birmingham
10:50 AM
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Adaptive Sample Size Re-Estimation for Time-to-Event Confirmatory Studies with Application to the Design of a CV/Renal Outcome Study
Yili Lu Pritchett, Astellas Pharma Global Development, Inc.; Hui Tang, AbbVie Inc.
10:55 AM
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Information-Based Sample Size Re-Estimation for Longitudinal Trials
Jing Zhou, UNC-Chapel Hill; Yue Shentu, Merck; Jiajun Liu, Regeneron Pharmaceuticals, Inc.; Keaven Anderson, Merck Research Laboratories
11:15 AM
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Practical Comparison of Sample Size Re-Estimation and Group Sequential Designs: Case Studies
William Prucka, Eli Lilly and Company
11:35 AM
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Generalized Optimal Design for Two-Arm, Randomized Phase II Clinical Trials with Endpoints from the Exponential Dispersion Family
Wei Jiang, University of Kansas Medical Center; Jonathan Mahnken, The University of Kansas Medical Center; Jianghua He, University of Kansas Medical Center; Matthew S. Mayo, University of Kansas Medical Center
11:50 AM
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A Comparison of Group Sequential Strategies for Three-Arm Noninferiority Trials
Toshimitsu Ochiai, Shionogi & Co., Ltd.; Toshifumi Sugitani, Osaka University Graduate School of Medicine; Yuko Ohno, Osaka University Graduate School of Medicine; Toshimitsu Hamasaki, Osaka University Graduate School of Medicine
11:50 AM
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Statistical Issues in Multiregional Clinical Trials
Suvajit Samanta, Merck Research Laboratory
3:05 PM
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Wednesday, 08/07/2013
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The Distribution of the Difference of Two Proportions: An Application of Sample Size Calculations Using Bayesian Approach
Mohammad Sahtout; Wijith Munasinghe, AbbVie
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Revisit Sample Size Estimation in Phase II Selection Designs
Zuoshun Zhang, Celgene Corporation; Angela Hu, Celgene Corporation
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Power and Sample Size Estimation for Genome-Wide Association Studies
Wei-Jiun Lin, Feng Chia University; James Chen, National Center for Toxicological Research, FDA; Kuang-Fu Cheng, Graduate Institute of Biostatistics and Biostatistics Center, China Medical University
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Recent Developments in Scaled Average Bioequivalence
Pascal Guibord, Algorithme Pharma
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Designing a Pilot Sequential Multiple Assignment Randomized Trial for Developing a Dynamic Treatment Regime
Daniel Almirall, University of Michigan; Scott N. Compton, Duke University; Meredith Gunlicks-Stoessel, University of Minessota; Naihua Duan, Departments of Psychiatry and Biostatistics, Columbia University; Susan Murphy, University of Michigan
8:35 AM
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Inference from Blinded Data in Randomized Clinical Trials
Kefei Zhou, Amgen. Co; Jeetu Ganju, Gilead
8:35 AM
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Projected Variance for the Model-Based Classical Ratio Estimator: Estimating Sample Size Requirements
James Knaub, US Energy Information Administration
9:00 AM
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Adaptive Blinded Bayesian Sample Size Re-Determination for Clinical Trials: Extensions and Risk Minimizations
Andrew Hartley, PPD, Inc
9:20 AM
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Sample Size Consideration for Treatment Effect Consistency Assessment in Multi-Regional Clinical Trials and Bridging Studies
Hui Quan, Sanofi; Gang Li, Johnson & Johnson; Josh Chen, Merck; Yue Shentu, Merck
10:35 AM
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Sample-Size Calculation for Comparing Two Negative Binomial Rates
Haiyuan Zhu, Forest Research Laboratories; Hassan Lakkis, Forest Research Laboratories
10:35 AM
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Targeting Minorities Using Address-Based Sampling: A Simulation Study
Francine Barrington, ICF International; Pedro Saavedra, ICF International
10:35 AM
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Evaluation of a Design with Sample Size Re-Estimation Based on Conditional Power
Alison Pedley
10:35 AM
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Negative Binomial Models for Two Period Cross-Over Trials Involving Overdispersed Count Data
Mallikarjuna Rettiganti, University of Arkansas for Medical Sciences; Haikady Nagaraja, The Ohio State University
10:50 AM
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Sample Size Re-Estimation at Interim Analysis for a Time-to-Event Endpoint for Data with Nonproportional Hazards
Liang Chen, Pfizer, Inc.
11:05 AM
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Bayesian Two-Stage Single-to-Double Arm Design in Phase II Clinical Trials
Guosheng Yin, University of Hong Kong
11:15 AM
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Sample-Size Evaluation in Group-Sequential Designs for Clinical Trials with Two Continuous Endpoints as Co-Primary Contrasts
Koko Asakura, Osaka University Graduate School of Medicine; Kenichi Hayashi, Osaka University Graduate School of Medicine; Tomoyuki Sugimoto, Hirosaki University Graduate School of Science and Technology; Takashi Sozu, Kyoto University School of Public Health; Toshimitsu Hamasaki, Osaka University Graduate School of Medicine
11:20 AM
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Sample-Size Calculation for Count Data in Comparative Clinical Trials with Nonuniform Patient Accrual and Early Dropout
Huiling Li, Forest Research Institute; Lin Wang, Sanofi, US; Lynn Wei, Sanofi, US; Hui Quan, Sanofi
11:35 AM
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Sample Size Re-Estimation with Missing Data in Clinical Trials
Ruitao Lin, Department of Statistics and Actuarial Science, University of Hong Kong; Guosheng Yin, University of Hong Kong; Huiqiong Li, Yunnan University
11:50 AM
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Conditional Power and Enrollment Strategies in a Time-to-Event Study with a Delay in Treatment Effect
Emelita de Leon-Wong, PPDI; Gary Greenfield, PPDI
2:35 PM
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Exploring Measurement System Study Sample Size and the Power to Detect Production Process Shifts
Laura Lancaster, SAS Institute Inc.; Christopher Gotwalt, SAS Institute
3:05 PM
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Thursday, 08/08/2013
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A Comparison of Sample Size Estimation Procedures Using Cost-Effective Methods
Sibabrata Banerjee, Allergan, Inc
8:50 AM
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Sample Size Re-Estimation in Confirmatory Studies
Min Lin
8:55 AM
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A Novel Design for Decision Rules Based on Statistical Testing Strategies in a Definitive Go/No-Go Clinical Study
Ming Zhou, Amylin Pharma., LLC (a Bristol-Myers Squibb Co.); Larry Z. Shen, Amylin Pharma., LLC (a Bristol-Myers Squibb Co.)
9:20 AM
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Fisherian Evidential Approach for Adaptive Doubly Randomized Withdrawal Designs
Qing Liu, Johnson & Johnson
9:55 AM
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Unbiased Small Sample Size Determination for Major Statistical Parameters
Eugene Demidenko, Dartmouth Medical School
11:05 AM
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Testing and Sample Size for Polygonal One-Sided Hypotheses on Bivariate Binary Outcomes
Menggang Yu, University of Wisconsin; Ziyue Liu, Indiana University Purdue University Indianapolis
11:20 AM
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Assessing Intra- and Inter-Rater Device Reliability in a Rare Disease
Avital Cnaan, Children's National Medical Center; Tina Duong, Children's National Medical Center; Fengming Hu, Children's National Medical Center
12:05 PM
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