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Sunday, 08/04/2013
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Adaptive Design of Oncology Trials Using Change in Tumor Size at Interim Analysis
Bin Zhang, Millennium Pharmaceuticals, Inc. and Boston University; Jing Wang, Boston University School of Public Health
2:05 PM
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An 'Early-Go' Design for Single-Arm, Two-Stage, Phase II Clinical Trials
William E. Brady, Roswell Park Cancer Institute; Gregory Wilding, Roswell Park Cancer Institute
2:35 PM
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Adjusting for Discordance Rates
Vijay Chauhan, Alpha Stats Inc; Grace Liu, Jansen Research Development ; Sudhakar Rao, Janssen Research & Development
2:45 PM
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Bayesian Approach for Evaluating Regional Treatment Effect in a Multiregional Global Trial
Jianchang Lin, Millennium: The Takeda Oncology Company; Guohui Liu, Millennium: The Takeda Oncology Company
3:05 PM
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A Simulation Study to Evaluate Accuracy and Precision of Blinded Independent Central Reviews (BICR) on Progression-Free Survival in Cancer Clinical Trials
Fenghai Duan, Brown University; Richard Walovitch, WorldCare Clinical, LLC; Vincent Girardi, WorldCare Clinical, LLC
3:05 PM
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Alternative Designs for Phase II Clinical Trials When Attained Sample Sizes Are Different from Planned Sample Sizes
Myron Chang, University of Florida
3:35 PM
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Statistical Assessment of Comparative Efficacy in Adolescent Psychiatry Clinical Trials
Isaac Nuamah, Janssen Research and Development
4:05 PM
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The Remarkable Robustness of Ordinary Least Squares in Randomized Clinical Trials
David Ross Judkins, Abt Associates; Kristin Porter, MDRC
4:05 PM
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Subgroup Identification in Randomized Clinical Trial Data Using Random Forests and Regression Trees
Jared Foster, University of Michigan; Jeremy Taylor, University of Michigan; Bin Nan, University of Michigan
5:05 PM
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Measurement Error in the Timing of Events: Effect on Survival Analyses in Randomized Clinical Trials
Lori Dodd, National Institutes of Health
5:05 PM
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Monday, 08/05/2013
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Comparing Different Methods of Handling Overrun in Group Sequential Trials
Timothy Skalland, Department of Statistics, Oregon State University; Sarah Emerson, Oregon State University
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Sample Size Calculations for Treatment and Biomarker Interactions
Scarlett Kazimer
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Post-GWAS Analysis of Snip Data with Applications to Systolic Blood Pressure Sensitivity to Weight and Sodium Change
Jie Liu, Rutgers University; Javier Cabrera, Dept of Statistics, Rutgers University; Jerry Q. Cheng, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School; John Kostis, Robert Wood Johnson Medical School, Rutgers University
8:35 AM
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Asthma and Clinical Challenges in Clinical Trials
Jonathan Goldin, UCLA Radiology
8:35 AM
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Beyond SAS versus R: Making the Case for Open Source Software in Clinical Trials
Kevin Buhr, University of Wisconsin
8:35 AM
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Biomarker Cutoff Identification in Clinical Trials with Biomarker-Driven Subgroups
Lin Wang, Sanofi, US; Lynn Wei, Sanofi, US
8:50 AM
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Pharmaceutical Users of Software Exchange (PhUSE) - a quick overview
Michael Carniello, Takeda Global Research & Development Center, Inc.
8:55 AM
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Nonparametric Testing Methods for Treatment-Biomarker Interaction Based on Local Partial-Likelihood
Yicong Liu, Queen's University; Wenyu Jiang, Queen's University; Bingshu E. Chen, NCIC Clinical Trials Group and Department of Community Health and Epidemiology, Queen's U
9:05 AM
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Personalized Medicine in Oncology: A Statistical Perspective
Cheng Rong, Amgen
9:20 AM
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Missing Data Imputation Under Intention-to-Treat
Steven Snapinn, Amgen
10:35 AM
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Longitudinal Trials with Adaptive Choice of Follow-Up Time
Neal Jeffries, National Heart, Lung, and Blood Institute,-NIH; Nancy L. Geller, Office of Biostatistics Research, NHLBI, NIH
10:50 AM
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A Novel Bayesian Approach to Designing Dose-Ranging Clinical Trials: A More Efficient Alternative to Traditional Approaches
Jianjun Gan, GlaxoSmithKline; Amy Cutrell, GlaxoSmithKline
11:05 AM
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Tumor Dynamics and Central-Review Bias in Progression-Free Survival Clinical Trials
Jonathan Siegel, Bayer HealthCare Pharmaceuticals
11:05 AM
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Practical Bayesian Computation in Clinical Trials
Karen Lynn Price, Eli Lilly and Company; Fang Chen, SAS Institute Inc.; Baoguang Han, Eli Lilly and Company
11:15 AM
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Study Designs in Induction/Maintenance Trials
Lixia Pei, Janssen Research & Development; Kevin Liu, Janssen Reseach & Development
11:20 AM
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An Adaptive Study Design for Dose-Finding Based on Both Safety and Immunologic Response for Oncology Clinical Trials
Elizabeth Garrett-Mayer, Hollings Cancer Center, Medical University of South Carolina; Cody Chiuzan, Hollings Cancer Center, Medical University of South Carolina
11:25 AM
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Identifying the Potential Risk Factors of Venous Thromboembolism Events in Clinical Trials
Kao-Tai Tsai
11:50 AM
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A Bayesian Design for Phase II Clinical Trials with Delayed Responses Based on Multiple Imputation
Chunyan Cai, UT Health Science Center at Houston; Suyu Liu, UT MD Anderson Cancer Center
11:50 AM
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Time-to-Event Surrogate Endpoint Predicting Overall Survival
Susan Halabi, Duke University; Chen-Yen Lin, Duke University
11:50 AM
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Randomization Methods Used in Clinical Trials
Dennis Sweitzer, Medidata Solutions
12:31 PM
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Implementing Adaptive Dose-Finding Designs in Oncology Clinical Trials
Bo Huang, Pfizer Inc.; Paul Bycott, Pfizer Inc.; Enayet Talukder, Pfizer Inc.
2:25 PM
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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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DMCs and the New Final Rule: How Will We (Should We) Respond?
Janet Wittes, Statistics-Collaborative
2:45 PM
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The Use of Historical Information in Clinical Trials
Kert Viele, Berry Consultants; Scott M. Berry, Berry Consultants
2:55 PM
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Calibration in the Continual Reassessment Method for Phase I Clinical Trials
Xiaoyu Jia, Columbia University; Shing M. Lee, Columbia University
3:05 PM
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Inference for Treatment Effects in Clinical Trials with Nonrandom Dropouts
Shan Kang, University of Michigan; Roderick J. Little, University of Michigan
3:20 PM
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Predicting Analysis Time in Event-Driven Clinical Trials When There Are Multiple Correlated Time-to-Event Endpoints
Jianming Wang, Celgene; Zhinuan Yu, Celgene
3:20 PM
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Tuesday, 08/06/2013
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Exploratory Subgroup Analysis: Subgroup Identification Approaches in Clinical Trials
Ilya Lipkovich; Alexei Dmitrienko, Quintiles
8:35 AM
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Hierarchical Bayesian Approaches to the Subgroup Analysis Problem in Infectious Disease Clinical Trials
Carl Dicasoli, Vertex Pharmaceuticals; Cynthia DeSouza, Vertex Pharmaceuticals ; Lan Lan , Vertex Pharmaceuticals
8:50 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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Monitoring Clinical Trials Based on the Bayesian Predictive Probability Using Data from Both Completers and Non-Completers
Qi Tang, AbbVie Inc.; Weining Zhao Robieson, AbbVie; Yili Lu Pritchett, Astellas Pharma Global Development, Inc.
9:05 AM
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Constrained Longitudinal Data Analysis as an Alternative to Multiple Imputation for Handling Missing Data in Randomized Clinical Trials
Jin Xu, Merck
9:05 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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Decisionmaking in Confirmatory Multipopulation Tailoring Clinical Trials
Brian Millen, Eli Lilly & Company; Alexei Dmitrienko, Quintiles
9:15 AM
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An Adaptive Design of Initial Therapy for Emergency Department Patients with Heart Failure
Jing Ning, The University of Texas MD Anderson Cancer Center; Sijin Wen, West Virginia University; Sean Collins, Vanderbilt University; Donald Arthur Berry, M.D. Anderson Cancer Center
9:20 AM
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Sensitivity Analyses in Clinical Trials via Pattern-Mixture Models Using Standard SAS Procedures for Multiple Imputations: How Much We Improve Over LOCF?
Anjela Tzontcheva, Merck
9:50 AM
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Covariate Effect on Constancy Assumption in Noninferiority Clinical Trials
Siyan Xu, Boston University; Kerry Barker, Pfizer Inc.; Sandeep Menon, Pfizer Inc.; Ralph D'Agostino, Sr., Boston University
10:35 AM
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Leveraging Longitudinal Data in Dose-Finding Studies
Chyi-Hung Hsu, Janssen Research & Development; Jose Carlos Pinheiro, Janssen R&D
11:00 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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Heterogeneity, Sensitivity, Resistance, Effectiveness
Lev Sverdlov
12:05 PM
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Globalization of Clinical Trials: The Development of Treatments and Preventative Products for Diseases and Allergies
Tammy Massie, US-FDA-CBER
12:31 PM
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Finding the Biologically Optimal Dose with Early Efficacy Biomarkers in Phase I Cancer Clinical Trials
Rui Qin, Mayo Clinic
2:25 PM
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Adaptive Adjustment of the Randomization Ratio Using Historical Control Data
Brian Hobbs, The University of Texas M.D. Anderson Cancer Center; Bradley P. Carlin, University of Minnesota; Daniel J. Sargent, Mayo Clinic
2:45 PM
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A Dose-Escalation Design for Combination Cancer Therapies
Jenny Zhang, Gilead Sciences
2:45 PM
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Statistical Issues in Multiregional Clinical Trials
Suvajit Samanta, Merck Research Laboratory
3:05 PM
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Improving Median Progression-Free Survival Methods Through Design or Analysis
Keaven Anderson, Merck Research Laboratories; Honghong Zhou, Merck Research Laboratories
3:05 PM
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Wednesday, 08/07/2013
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Impact of Ignoring Correlations in Vision Clinical Trials
Ratna Revankar, Johnson & Johnson; Gary Koch, The University of North Carolina-Chapel Hill; Atsushi Kawaguchi, The University of North Carolina
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A Proposed Modification to Hy's Law and Edish Criteria: Using Aggregated Historical Data of Oncology Clinical Trials/ Generally Healthy Patients' Data
Daniel Parks, GlaxoSmithKline; Xiwu Lin, GSK; Kwan Lee, GSK
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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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Simulation of Safety Data for Clinical Trials
Scott Diegel, University of Wisconsin; John Kloke, University of Wisconsin; Neil Baron, University of Wisconsin
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Recent Developments in Scaled Average Bioequivalence
Pascal Guibord, Algorithme Pharma
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Effects of Randomization Methods on Hypotheses Tests in Some Clinical Trials
Shaocheng Liu, MTDA; June Li, MTDA
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Make Small Clinical Trials/Studies Valuable
Anna Nevius, Food and Drug Administration/CVM
7:01 AM
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The Contributions of Robert T. O'Neill to the Evolution of Regulatory Statistical Science
Charles Anello, Applied Statistical Concepts, LLC; Suzanne Junod, US FDA Office of Public Information and Library Servics, FDA History Office
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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The Phenotypic Squeeze: What Can We Realistically Expect from Genetically Personalized Medicine and What Can Statisticians Do to Help Realize It?
Stephen Senn, CRP-Sante
8:55 AM
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Modeling and Interpretation of Vaccine Cross-Over Clinical Trials Data
Scott Patterson; Byron Jones, Novartis Pharma AG; Michael Kenward, University of London
9:05 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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Small-Scale Studies and Their Impact on Phase III Trials: Vanguards, Pilot Studies, and Run-Ins
Sarah Baraniuk, UT-School of Public Health
9:35 AM
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Bayesian Design of Noninferiority Clinical Trials via Conditional Borrowing of Historical Data with Applications
Ming-Hui Chen, University of Connecticut
10:35 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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Assessing the Success of the Blind in Sham-Controlled Randomized Clinical Trials
Valerie Durkalski, Medical University of South Carolina; Qi Wu, Medical University of South Carolina
10:55 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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Adjusting for Selection Bias in Single-Blinded Randomized Controlled Clinical Trials
Lieven Kennes, RWTH Aachen University
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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Data Mining Heterogeneity of Treatment Effects on Patients with the Metabolic Syndrome
Hua Fang, Umass Medical School; Jin Wang, UMass Dartmouth; Bruce Barton, University of Massachusetts Medical School; Honggang Wang, University of Massachusetts Dartmouth; Yunsheng Ma, University of Massachusetts Medical School
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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Extrapolating Survival Curves in Clinical Trials Beyond Follow-Up Periods
Jerry Cheng, Robert Wood Johnson Medical School, Rutgers University; Javier Cabrera, Dept of Statistics, Rutgers University; John Kostis, Robert Wood Johnson Medical School, Rutgers University; David Madigan, Columbia University
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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Testing for and Characterizing Treatment Effect Heterogeneity Under the Neyman-Rubin Potential Outcomes Framework
Luke Miratrix, Harvard University; Avi Feller, Harvard University; Peng Deng, Harvard University
11:55 AM
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Robust Borrowing from Historical Data with Meta-Analytic-Predictive Mixture Priors
Beat Neuenschwander, Novartis Pharma AG; Sandro Gsteiger, Novartis Pharma; Satrajit Roychoudhury, Novartis Pharmaceuticals Corporation; Heinz Schmidli, Novartis Pharma
2:05 PM
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Guarantee Time Bias: A Discussion About the Analysis of Survival by Tumor Response and Other Comparisons of Time-to-Event by Outcome Variables
James R. Anderson, University of Nebraska Medical Center; Robert W. Makuch, Yale School of Public Health; Anita Giobbie-Hurder, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute; Nicholas Jewell, University of California Berkeley
2:05 PM
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Particular Challenges of Sequential Analysis in Cluster-Randomized Trials
Abigail Shoben, The Ohio State University
2:05 PM
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Hypothesis Testing of Covariate-Adaptive Randomized Clinical Trials Under Generalized Linear Models
Wei Ma, University of Virginia; Feifang Hu, University of Virginia
2:20 PM
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A Group Sequential Method Using Hochberg Procedure for Clinical Trials with Multiple Primary Endpoints
Kentaro Sakamaki, Yokohama City University
2:20 PM
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Sensitivity Analysis Using Enhanced Tipping-Point Displays for Studies with Dichotomous Treatment and Partially Missing Outcomes
Victoria Liublinska, Harvard University; Donald B. Rubin, Harvard University
2:25 PM
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Ensuring Assay Sensitivity in Analysis of Noninferiority Trials with Missing Data
Brian Wiens, Alcon Laboratories
2:45 PM
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Response-Adaptive Randomization in the Presence of Mismeasurement
Xuan Li, University of Minnesota Duluth; Xikui Wang, University of Manitoba
3:05 PM
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Thursday, 08/08/2013
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Multiple Imputation of Heaped Longitudinal Cigarette Count Data
Sandra D. Griffith, Cleveland Clinic ; Saul Shiffman, University of Pittsburgh; Yimei Li, The Childrens' Hospital of Philadelphia; Daniel F. Heitjan, University of Pennsylvania
8:35 AM
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Interim Monitoring of Longitudinal Outcomes in Clinical Trials
Michael McDermott, Univ of Rochester Medical Center; Xueya Cai, Univ of Rochester Medical Center
8:55 AM
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Recent Advances in Design and Methodology in Psychiatric Clinical Trials
Peiling Yang, Food and Drug Administration
9:15 AM
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Data-Monitoring Committees in China
Kent Koprowicz, Axio Research LLC; Tingting Li, Axio Research; Xiaohui Huang, Axio Research; Ping Xu, Axio Research Coporation
9:35 AM
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Teaching Clinical Trials to Nonstatisticians
Richard Holubkov, Univ of Utah Pediatrics; Susan Elizabeth Telke, University of Minnesota - Twin Cities; Christopher Assaid, Merck & Co; Marianne Bertolet, University of Pittsburgh
10:35 AM
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Confidence Intervals for an Exposure-Adjusted Incidence Rate Difference with Applications to Clinical Trials
Junyuan Wang, BMS; G. Frank Liu, Merck Res Labs; Ken Liu, Merck & Co., Inc.; Snavely Duane, Merck & Co., Inc.
10:35 AM
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Likelihood-Based Methods for Exposure-Adjusted Incidence Data Analysis in Clinical Trials
Jing Xu, Millennium Pharmaceuticals, Inc.
10:55 AM
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Nonparametric Approaches for Exposure-Adjusted Incidence Data Analysis in Clinical Trials
Huyuan Yang, MPI
11:15 AM
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Evaluating Surrogate Endpoints: A New Trial-Level Surrogacy Metric Based on Concordance of Significance of Treatment Effects
Qian Shi; Lindsay A. Renfro, Mayo Clinic; Daniel J. Sargent, Mayo Clinic
12:05 PM
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