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Keyword Search Criteria: trial returned 272 record(s)
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Sunday, 07/29/2018
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Some Thoughts on AIG from a Canadian Perspective
Nancy Reid, University of Toronto; David Alexander Campbell, Simon Fraser University
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Monitoring Rare Events During an Ongoing Clinical Trial
Haley Hedlin, Stanford University; Victoria Ding, Quantitative Sciences Unit, Stanford School of Medicine
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Sample Size Calculations for Non-Inferiority Trials Using the Concept of Proportional Time
Milind A Phadnis, University of Kansas Medical Center
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Using Historical Controls in CNS Clinical Trials
Xiang Ling, FDA/CDER/OTS/OB; Kun Jin, FDA; Hsien-Ming James Hung, PhD, Food and Drug Administration
2:05 PM
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Application of Propensity Score Quintile Matching for Baseline Parameters in a Medical Device Trial Design
Hong Wang, Boston Scientific Corporation; Songtao Jiang, Boston Scientific; Peter Lam, Boston Scientific
2:05 PM
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Regression-Adjusted Estimators in Randomized Experiments with a Diverging Number of Predictors
Lihua Lei, UC Berkeley; Peng Ding, UC Berkeley
2:20 PM
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Statistical Development in Addressing Delayed Treatment Effect or Crossing Survival Curves in Immuno-Oncology Clinical Trials
Huyuan Yang, Takeda Oncology Pharmaceutical
2:20 PM
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Designing Trials Using Bayesian Methods with Historical Controls
Michael Sonksen, Eli Lilly and Company
2:25 PM
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An Adaptive Test of Significance in the Presence of Uncertainty in the Timing of the Final Analysis
Jeremy Gorelick, Edwards Lifesciences
2:35 PM
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Bayesian Population Finding Using Counterfactual Modeling of Responses
Peter Müller, University of Texas Austin; Satoshi Morita, Kyoto University
2:45 PM
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Advancing Methodologies for Clinical Trials Using Historical Control
Min Min, U.S. Food and Drug Administration, CDER/OTS/OB; Yeh-Fong Chen, US FDA
2:45 PM
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Dose Selection Using Nonlinear Mixed-Effect Model Averaging Approaches in Conjunction with Adaptive Optimal Design Techniques
Andrew Hooker, Uppsala Universitet
2:45 PM
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Leveraging Existing Information in Medical Device Clinical Trials
Rajesh Nair, CDRH/FDA; Xuefeng Li, CDRH/FDA; Laura Thompson, CDRH/FDA
3:05 PM
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Correlation Between the Time-To-Event Endpoints in Prostate Cancer Clinical Trials
Susan Li, Janssen R&D
3:05 PM
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Statistical Evaluation of Oncology Drug Trial Portfolios and the Potential for Inappropriate Regulatory Approval: a Simulation Study
Renee Gennarelli, Memorial Sloan Kettering Cancer Center; Peter Bach, Memorial Sloan Kettering Cancer Center; Mithat Gonen, Memorial Sloan Kettering Cancer Center
3:20 PM
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Simulation Study on the Impact of Accuracy of Estimated Genetic Relationship Matrices on Predicting Genotype Performance
MINGZHU SUN, The University of Queensland; Vivi Arief, UNIVERSITY OF QUEENSLAND; Ian DeLacy, UNIVERSITY OF QUEENSLAND; Kaye Basford, UNIVERSITY OF QUEENSLAND; Wen-Hsi Yang, UNIVERSITY OF QUEENSLAND
3:20 PM
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Sample Size Calculations for Non-Inferiority Trials Using the Concept of Proportional Time
Milind A Phadnis, University of Kansas Medical Center
3:25 PM
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A Case Study on Model Based Meta-Analysis (MBMA) for Drug Development Decisions
Guohui Liu, Takeda Pharmaceuticals Inc ; Zhaoyang Teng, Takeda pharmaceuticals international, Co; Zhaowei Hua, Takeda Pharmaceuticals International Co.; Neeraj Gupta, Takeda pharmaceuticals international, Co; Richard Labotka, Takeda pharmaceuticals international, Co
3:35 PM
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Monitoring Rare Events During an Ongoing Clinical Trial
Haley Hedlin, Stanford University; Victoria Ding, Quantitative Sciences Unit, Stanford School of Medicine
3:40 PM
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A Gate-Keeping Test for Selecting Adaptive Interventions for Depression Management Under General SMART Designs
Xiaobo Zhong, Columbia University; Bin Cheng, Columbia University; Min Qian, Columbia University; Ying Kuen Ken Cheung, Columbia University
4:20 PM
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Sample Size and Power Calculation for Immuno-Oncology Clinical Trials
Binbing Yu, MedImmune, Inc.; Dongyue FU, MedImmune, Inc.; Hefei (Harry) Yang, MedImmune, Inc.
4:20 PM
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Design and Analysis of Survival Trials with Treatment Crossover
Xiaodong Luo, Sanofi
4:25 PM
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A Glimpse into Industry Experience with RWE to Transform Pharmaceutical Research and Development
James Harnett
4:25 PM
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Q-Learning for Dynamic Treatment Regimes on CODIACS Vanguard Randomized Controlled Trial
Eun Jeong Oh, Columbia; Min Qian, Columbia University; Ying Kuen Ken Cheung, Columbia University
4:35 PM
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Two-Stage Enrichment Clinical Trial Design with Adjustment for Misclassification in Predictive Biomarkers
Yong Lin, Rutgers, The State University of New Jersey; Weichung Joe Shih, Rutgers University; Shou-En Lu, Rutgers University
4:35 PM
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Case Studies of Non-Proportional Hazards in Oncology and Hematology Trials
Jingjing Ye, FDA
4:45 PM
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Real World Evidence Demonstration Projects and Policy Development at FDA
Diqiong Xie, FDA; David Barrett Martin, FDA CDER OMP
4:45 PM
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Inference and Optimal Design for Longitudinal Cluster-Randomized Clinical Trials Given a Small Number of Clusters with Application to a Serious Mental Illness Intervention Study
CHAE RYON KANG, University of Pittsburgh; DI ZHANG, University of Pittsburgh
4:50 PM
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Clinical Trial Technologies for Precision Medicine: The Current State of the Art
Steven J Schwager, Medidata Solutions; Ruthanna Davi, Medidata Solutions; Therese Dolan, Medidata Solutions; Jeff Wiser, Medidata Solutions
4:50 PM
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Design and Analysis of Cancer Immunotherapy Trials with Potential Violation of Proportional Hazards Assumption
Xiaofei Wang, Duke University School of Medicine; Guangyu Yang , University of Michigan
5:05 PM
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A Hybrid Approach for Prediction of Event Times in Double-Blind Clinical Trials
Ming Zhu, Sanofi Pasteur; Yunnan Xu, Virginia Tech; Zheng Su, Deerfield Institute
5:05 PM
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MCP-Mod Based Quantitative Techniques for Decision Making Process in Phase II Dose-Finding Clinical Trials
Na Cai, Astellas; Annie Wang, Astellas Pharma; Michael Smith, Astellas
5:20 PM
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Novel Approach in Analyzing Difference in Binomial Proportions in Stratified Clinical Trials
Anindita Banerjee, Pfizer; Vivek Pradhan, Pfizer
5:35 PM
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Monday, 07/30/2018
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Randomization Tests in Randomized Clinical Trials: Beyond Population
Yanying Wang, George Mason University; Diane Uschner, RWTH Aachen University; William Fisher Rosenberger, George Mason University
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Challenges in Oncology: Pragmatic Trials Using Real-World Evidence
Zhe Zhang, Pfizer
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Machine-Learning Approach to Defining Covariates to Increase Study Power in ALS Clinical Trials and Other Multifactorial Heterogeneous Disease Areas
Danielle Beaulieu, Origent Data Sciences; Albert Taylor, Origent Data Sciences; Samad Jahandideh, Origent Data Sciences; David Ennist, Origent Data Sciences; Andrew Conklin, Origent Data Sciences; Mike Keymer, Origent Data Sciences
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Improving Health Outcomes on the Last Mile of a Learning Healthcare System - the Importance of Leading with Statistics
Daniel Byrne, Vanderbilt University; Henry Domenico, Vanderbilt; Li Wang, Vanderbilt
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Is Randomization ". a Fetish of a Piece of Nonsense,.." ?
Donald Taves
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Statistical Methods for Evaluating the Correlation Between Timeline Follow-Back Data and Daily Process Data: Results from a Randomized Controlled Trial
Wanjun Liu, Penn State University
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Standard Analyses and Displays for Common Clinical Trial Data: An Industry-Wide Initiative
Mercidita Navarro, Genentech
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Add a Patient Selected Treatment Arm in a Randomized Trial
Xueliang Pan; Lai Wei, The Ohio State University; Jill Heathcock, The Ohio State University
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Composite Endpoints for Alzheimer's Disease Clinical Trials
Steve Edland, University of California, San Diego
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Bayesian Forecasting and Dynamic Modeling of Physical Processes in Industrial Hygiene
Nada Abdalla, UCLA; Sudipto Banerjee, UCLA School of Public Health; Gurumurthy Ramachandran, John Hopkins University; Susan Arnold, University of Minnesota
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Power and Sample Size Requirements for GEE Analyzes of Cluster Randomized Crossover Trials
Fan Li, Duke Univeristy; Andrew Forbes, Monash University; Elizabeth L. Turner, Duke Global Health Institutes; John S. Preisser, University of North Carolina at Chapel Hill
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Open Data Sharing and Its Statistical Limitations
Pooja Iyer, RTI International; Barbara Do, RTI International
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Efficient Design and Analysis of Cluster Randomized Trials
Hengshi Yu, University of Michigan, Ann Arbor; Fan Li, Duke Univeristy; John A. Gallis, Duke University; Elizabeth L. Turner, Duke Global Health Institutes
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A Comparison of Modeling Approaches for Stepped-Wedge Cluster Randomized Trials That Include Multilevel Clustering, Confounding by Time, and Effect Modification
Lance Ford, University of Oklahoma Health Sciences Center; Julie A Stoner, University of Oklahoma Health Sciences Center; Daniel Zhao, OU Health Sciences Center; Tabitha Garwe, University of Oklahoma Health Sciences Center; Ann Chou, University of Oklahoma Health Sciences Center; Daniel Duffy, University of Oklahoma-Tulsa
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Symptom Trials Vs Morbidity/Mortality Trials: Are Different Estimands Required?
Steven Snapinn, Amgen, Inc.
8:35 AM
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Basket Trial Design Using Bayesian Model Averaging
Matthew Psioda, University of North Carolina; Jiawei Xu, University of North Carolina; Qi Jiang, Amgen; Chunlei Ke, Biogen; Zhao Yang, Amgen Inc; Joseph G Ibrahim, University of North Carolina Chapel Hill
8:35 AM
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Formulation of Data Monitoring Committee Recommendations for Adaptive Design Clinical Trials
Navneet Hakhu, Axio Research
8:50 AM
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A Bayesian Logistic Model with Covariate to Identify Optimal Dose for Heterogeneous Population in Phase I Oncology Trial
Xin Wei, Celgene Corporation; Michael Branson, celgene corporation
8:50 AM
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CERBOT, a Web-Based Support Tool for the Emulation of a Target Trial Using Observational Data
Yi Zhang, Medical Technology and Practice Patterns Institute; Mae Thamer, Medical Technology and Practice Patterns Institute; Miguel Hernan, Harvard School of Public Health
9:15 AM
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A Hybrid Method for the Stratified Mark-Specific Proportional Hazards Models with Missing Data, with Applications to Dengue Vaccine Efficacy Trials
Yanqing Sun, University of North Carolina At Charlotte; Li Qi, Biostatistics and Programming, Sanofi; Peter Gilbert, Fred Hutchinson Cancer Research Center; Fei Heng, University of North Carolina at Charlotte
9:15 AM
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Improving the Design of Pragmatic Clinical Trials Using Data Collected from Electronic Medical Records
Susan Shortreed, Kaiser Permanente Washington Health Research Institute; Carlyn M Rutter, RAND Corporation; Andrea J. Cook, Kaiser Permanente Washington Health Research Institute; Greg Simon, Kaiser Permenete Washington Health Research Insitute
9:15 AM
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Open Data Sharing and Its Statistical Limitations
Pooja Iyer, RTI International; Barbara Do, RTI International
9:35 AM
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Sample Size Considerations for Comparing Dynamic Treatment Regimens in a Sequential Multiple-Assignment Randomized Trial with a Continuous Longitudinal Outcome
Nicholas J Seewald, University of Michigan; Kelley M Kidwell, University of Michigan; James R McKay, University of Pennsylvania; Inbal Nahum-Shani, University of Michigan; Daniel Almirall, University of Michigan
9:35 AM
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Closed-Form Solutions for Group Sequential Design in Survival Trials with Non-Proportional Hazards
Jianliang Zhang, Medimmune, LLC; Erik Pulkstenis, AbbVie
10:05 AM
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A Bayesian Phase I/II Trial Design for Immunotherapy
Suyu Liu, MD Anderson Cancer Center; Beibei Guo, Louisiana State University; Ying Yuan, University of Texas M.D. Anderson Cancer Center
10:35 AM
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Data Enriched Generalized Linear Methods
Sayan Dasgupta, Fred Hutchinson Cancer Research Center; Cheng Zheng, University of Wisconsin at Milwaukee ; Ying Qing Chen, Fred Hutchinson Cancer Research Center; Asad Haris, University of Washington
10:35 AM
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Leveraging Omics Biomarker in Early Clinical Trials - Concept, Utility and Impact on Decision Making
Weidong Zhang, Pfizer Inc.
10:35 AM
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Recent Challenges in Vaccine Clinical Development
Tsai-Lien Lin, FDA/CBER
10:35 AM
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Achieving Optimal Power of Logrank Test with Random Treatment Time-Lag Effect
Zhenzhen Xu , FDA; Yongsoek Park, Unversity of Pittsburgh; Boguang Zhen, FDA; Bin Zhu, NIH/NCI
11:00 AM
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Efficient Design and Analysis of Cluster Randomized Trials
Hengshi Yu, University of Michigan, Ann Arbor; Fan Li, Duke Univeristy; John A. Gallis, Duke University; Elizabeth L. Turner, Duke Global Health Institutes
11:00 AM
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Use of Piecewise Weighted Log-Rank Test for Trials with Delayed Treatment Effect
Boguang Zhen, FDA; Zhenzhen Xu , FDA; Bin Zhu, NIH/NCI; Yongsoek Park, Unversity of Pittsburgh
11:25 AM
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Power and Sample Size Requirements for GEE Analyzes of Cluster Randomized Crossover Trials
Fan Li, Duke Univeristy; Andrew Forbes, Monash University; Elizabeth L. Turner, Duke Global Health Institutes; John S. Preisser, University of North Carolina at Chapel Hill
11:30 AM
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Bayesian Forecasting and Dynamic Modeling of Physical Processes in Industrial Hygiene
Nada Abdalla, UCLA; Sudipto Banerjee, UCLA School of Public Health; Gurumurthy Ramachandran, John Hopkins University; Susan Arnold, University of Minnesota
11:45 AM
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Practical Considerations on the Challenges to the Design and Analysis of Immuno-Oncology Trials
Yabing Mai, AbbVie, Inc; Yue Shentu, Merck and Co Inc
11:50 AM
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A Comparison of Modeling Approaches for Stepped-Wedge Cluster Randomized Trials That Include Multilevel Clustering, Confounding by Time, and Effect Modification
Lance Ford, University of Oklahoma Health Sciences Center; Julie A Stoner, University of Oklahoma Health Sciences Center; Daniel Zhao, OU Health Sciences Center; Tabitha Garwe, University of Oklahoma Health Sciences Center; Ann Chou, University of Oklahoma Health Sciences Center; Daniel Duffy, University of Oklahoma-Tulsa
11:55 AM
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An Application of 2-In-1 Adaptive Phase 2/3 Design for Expedited Oncology Drug Development
Xinqun (Maggie) Chen, Merck & Co., Inc.; Linda Sun, Merck & Co., Inc.; Cong Chen, Merck & Co.
2:05 PM
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Extension of Bayesian Logistic Regression Model (BLRM) for Dose Timing Selection in Oncology Phase I Combination Studies
Yiyun Zhang, Novartis; Nigel Yateman, Novartis; Fang Xiang, Novartis; Lan Yi, Novartis; Kapildeb Sen, Novartis; Beat Neuenschwander, Novartis
2:05 PM
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A Location-Adjusted Approach to the Covariate-Adjusted Response-Adaptive Allocation Design in Multi-Center Trials
Brian S Di Pace, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University; David C. Wheeler, Virginia Commonwealth University
2:10 PM
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Sample Size Calculation for Pilot Studies
Chi-Hong Tseng, UCLA; Danielle SIM, UCLA
2:15 PM
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Critical Steps for Composite Endpoint Analysis
Jerry J. Li, Merck & Co., Inc.
2:20 PM
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Considering Delayed Treatment Effect in Trial Designs with Survival Endpoints
Kaushal Mishra, Novartis Oncology Pharmaceuticals; Kalyanee Viraswami Appanna, Novartis Pharmaceuticals
2:20 PM
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A Generalized Design for a Confirmatory Basket Trial
Robert Beckman, Georgetown University; Xiaoyun (Nicole) Li, Merck
2:25 PM
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Phase I Designs That Allow for Uncertainty in the Attribution of Adverse Events
Alexia Iasonos, Memorial Sloan Kettering Cancer Center; John O'Quigley, Universit'e Pierre et Marie Curie,
2:35 PM
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Are Tumor Size Changes Predictive of Survival for Immunotherapy Trials?
Meihua Wang, Merck & Co.; Thomas Jemielita, Merck & Co.; Cong Chen, Merck & Co.; Chen Hu, Johns Hopkins University
2:35 PM
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A Bayesian Analysis of Small N Sequential Multiple Assignment Randomized Trials (SnSMARTs)
Boxian Wei, University of Michigan, Ann Arbor; Kelley M Kidwell, University of Michigan; Thomas M Braun, University of Michigan; Roy N Tamura, University of South Florida
2:40 PM
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Utilizing Partial Extrapolation of Adult Data to Develop Confirmatory Pediatric Trials
JonDavid Sparks, Eli Lilly and Company; Ryan Sides, Eli Lilly and Company; Fanni Natanegara, Eli Lilly and Company
2:45 PM
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GBM AGILE: a Phase II/III Platform Design with Signature Identification
Todd Graves, Berry Consultants LLC; Donald A Berry, Berry Consultants and M.D. Anderson Cancer Center; Jason Connor, ConfluenceStat LLC
2:45 PM
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A Strategy for the Design and Analysis of Bridging Studies
Eric Holmgren, Beigene
2:50 PM
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A Parametric Multiple Comparison Procedure for Clinical Trials with Planned Evaluation of Treatment Effect in Pre-Defined Subgroups and Interim Analyzes
Liang Fang, MyoKardia; Ron Yu, Gilead Sciences, Inc.; Zhishen Ye, Gilead Sciences; Neby Bekele, Gilead Sciences; Ming Lin, Gilead Sciences
3:05 PM
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Bayesian Isotonic Optimal Dose Design for Phase I/II Clinical Trials with Ordered Groups
Xiaoqiang Xue
3:05 PM
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Statistical Approaches for Assessing the Utility of Urinary Glycosaminoglycans as a Surrogate Endpoint in Clinical Trials
Di Xiao, The Food and Drug Adminstration; Yeh-Fong Chen, US FDA; Min Min, U.S. Food and Drug Administration, CDER/OTS/OB
3:05 PM
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Multiple Imputation Strategies for Handling Missing Data When Generalizing Randomized Clinical Trial Findings Through Propensity Score-Based Methodologies
Albee Ling, Stanford University; Maya Mathur, Stanford University; Kris Kapphahn, Stanford University; Maria Montez-Rath, Stanford University; Manisha Desai, Stanford University
3:05 PM
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Evaluation of Regional Efficacy Equivalence in Developing Biosimilars
Ryuji Uozumi, Kyoto University Graduate School of Medicine; Shinjo Yada, A2 Healthcare Corporation
3:20 PM
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Statistical Methodologies to Detect Ineffective Regional Treatment Effect in a Multiregional Trial
Hsiao-Hui Tsou, National Health Research Institutes; Yu-Chieh Cheng, National Health Research Institutes; Chin-Fu Hsiao, National Health Research Institutes
3:35 PM
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Tuesday, 07/31/2018
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The Role of Mobile Health in Precision Medicine
Susan Murphy, Harvard University
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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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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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Sample Size and Assurance Probability Calculation in Multi-Regional Clinical Trials
Zuoshun Zhang, Celgene Corporation
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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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Preventing False Discovery of Heterogeneous Treatment Effect Subgroups in Randomized Trials
Joseph Rigdon, Stanford University; Michael Baiocchi, Stanford University; Sanjay Basu, Stanford University School of Medicine
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Optimal Sample Size for Cluster Randomized Trials: a Simulation-Based Search Algorithm
Ruoshui Zhai, Brown University; Roee Gutman, Brown University
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Transforming Data: a Case Study Using C-Peptide Data from Type 1 Diabetes Clinical Trials
Lia Weiner, Rho; Lynette Keyes-Elstein, Rho; Karen Boyle, Rho
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Patient- and Site-Level Factors Associated with Abstinence Outcome in a Multisite Clinical Trial of a Technology-Delivered Psychosocial Intervention for Substance Use Disorders
Martina Pavlicova, Columbia University; Leila M. Vaezazizi, New York State Psychiatric Institue; Aimee N. C. Campbell, New York State Psychiatric Institute; Mei-Chen Hu, Columbia University; Edward V. Nunes, New York State Psychiatric Institute
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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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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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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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Completion Rates and Considerations for Analyses of Patient-Reported Outcomes in Open-Label Cancer Trials: FDA Review of Trials, 2007 - 2017
Jessica K. Roydhouse, Office of Hematology and Oncology Products, US Food and Drug Administration; Mallorie H. Fiero, Office of Biostatistics, US Food and Drug Administration; Bellinda King-Kallimanis, Office of Hematology and Oncology Products, US Food and Drug Administration; Paul G. Kluetz, Oncology Center of Excellence, US Food and Drug Administration
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Use of Modified Risk Function in Drug Intervention Planning
Myung Shin Sim, UCLA
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Sample Size Calculation for a Pilot Study
Danielle Sim, UCLA; Chi-Hong Tseng, UCLA
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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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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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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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Response to Regulatory Issues in an Adaptive Medical Device Study
Jill Stankowski, ICON Plc
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Estimation and Inference for Cluster-Randomized Test-Negative Design Trials
Suzanne M. Dufault, University of California, Berkeley; Nicholas P. Jewell, University of California, Berkeley
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Clinical Trial Data Transparency and Patient Privacy
Darcy Hille, Merck & Company Inc; T. Ceesay, Merck ; Jonathan Hartzel, Merck
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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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Adaptively Incorporating Supplemental Information in Clinical Trials in the Presence of Population Heterogeneity
Joseph Koopmeiners, Division of Biostatistics, University of Minnesota; Ales Kotalik, University of Minnesota; David Michael Vock, University of Minnesota
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The Importance of Protocol Objectives to the Statistical Analysis
Richard McNally, Covance-Chiltern
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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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Sample Size Calculation for Pilot Studies
Chi-Hong Tseng, UCLA; Danielle SIM, UCLA
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Phase I Designs That Allow for Uncertainty in the Attribution of Adverse Events
Alexia Iasonos, Memorial Sloan Kettering Cancer Center; John O'Quigley, Universit'e Pierre et Marie Curie,
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Discovering Biomarkers Jointly Modeled with Multiple Efficacy Variables in Early Phase Clinical Trials
Danni Yu, Eli Lilly and Company
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Statistical Ethics and Challenging Substantial Errors in Statistical Methods and Results in a Prominent Peer Reviewed Economics Journal
Chris Barker, Statistical Planning and Analysis Services, Inc.
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A Bayesian Analysis of Small N Sequential Multiple Assignment Randomized Trials (SnSMARTs)
Boxian Wei, University of Michigan, Ann Arbor; Kelley M Kidwell, University of Michigan; Thomas M Braun, University of Michigan; Roy N Tamura, University of South Florida
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Performance Comparison of Post-Hoc Subgroup Search Algorithms for Clinical Trials
Victor Talisa, University of Pittsburgh; (Joyce) Chung-Chou H. Chang, University of Pittsburgh
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Conditional Power Calculation for the Interim Monitoring of Cluster-Randomized Trials with Interval-Censored Endpoints
Kaitlyn Cook, Harvard University; Rui Wang, Harvard Pilgrim HealthCare Institute
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A Location-Adjusted Approach to the Covariate-Adjusted Response-Adaptive Allocation Design in Multi-Center Trials
Brian S Di Pace, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University; David C. Wheeler, Virginia Commonwealth University
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Multiple Testing Procedure Consideration in Clinical Trials
Rachael Wen, Sanofi
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Bridging Information Between Dose-Response Curves Across Populations in Early Phase Clinical Trials
Moreno Ursino, Inserm DR PA 6
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Some T-Tests for N-Of-1 Trials with Serial Correlation: Correction Factors for Trials with Few Observations
Reid D. Landes, University of Arkansas for Medical Sciences; Ji-Ling Tang, University of Arkansas for Medical Sciences; Mark S Mennemeier, University of Arkansas for Medical Sciences; J. Tyler Floyd, University of Central Arkansas; Anne Holbrook, McMaster University
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Expected Versus Observed Effects on Conditional Probability for Clinical Trial Futility Assessment
Zhibao Mi, VA CSPCC Perry Point; Kelsey A.L. Alexovitz, VA Cooperative Studies Program Coordinating Center; Xiaoli Lu, VA Cooperative Studies Program Coordinating Center; Kousick Biswas, VA Cooperative Studies Program Coordinating Center; Joseph F Collins, VA Cooperative Studies Program Coordinating Center
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Some T-Tests for N-Of-1 Trials with Serial Correlation
Ji-Ling Tang, University of Arkansas for Medical Sciences; Reid D. Landes, University of Arkansas for Medical Sciences; Anne Holbrook, McMaster University; Mark S Mennemeier, University of Arkansas for Medical Sciences; J. Tyler Floyd, University of Central Arkansas
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Real-Time Study Milestone Projection in Clinical Trials with Time-To-Event Endpoints
Yanping Liu, Merck & Co.; Gang Jia, Merck & Co.
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Design Considerations When Comparing Control, Treatment, and Treatment Plus in Randomized Trials
Abigail Shoben, Ohio State University
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Statistical Approaches for Assessing the Utility of Urinary Glycosaminoglycans as a Surrogate Endpoint in Clinical Trials
Di Xiao, The Food and Drug Adminstration; Yeh-Fong Chen, US FDA; Min Min, U.S. Food and Drug Administration, CDER/OTS/OB
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Social Media and Clinical Research
Darcy Hille, Merck & Company Inc; T. Ceesay, Merck
8:35 AM
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Complexity of Implementing Sample Size Re-Estimation (SSR) in Oncology Trials
Alicia Zhang, Amgen; Yuqi Chen, Amgen; Chris Holland, Amgen
8:35 AM
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Bridging Information Between Dose-Response Curves Across Populations in Early Phase Clinical Trials
Moreno Ursino, Inserm DR PA 6
8:45 AM
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Incorporating Historical Information into the Analysis of Clinical Trials- a Case Study
Guochen Song, Biogen; Yiqing Tian, Q2 Sulotions; John Zhong, Biogen; Stacy Lindborg, Biogen Idec
8:50 AM
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Desirability Functions for Evaluating Clinical Trial Design Quality
Priscilla K Yen, UCLA; Weng Kee Wong, UCLA
8:50 AM
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The Myth of Making Inference for Overall Treatment Efficacy with Data from Multiple Studies via Meta-Analysis
Brian Claggett, Harvard Medical School
8:55 AM
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Expected Versus Observed Effects on Conditional Probability for Clinical Trial Futility Assessment
Zhibao Mi, VA CSPCC Perry Point; Kelsey A.L. Alexovitz, VA Cooperative Studies Program Coordinating Center; Xiaoli Lu, VA Cooperative Studies Program Coordinating Center; Kousick Biswas, VA Cooperative Studies Program Coordinating Center; Joseph F Collins, VA Cooperative Studies Program Coordinating Center
8:55 AM
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Conditional Power Calculation for the Interim Monitoring of Cluster-Randomized Trials with Interval-Censored Endpoints
Kaitlyn Cook, Harvard University; Rui Wang, Harvard Pilgrim HealthCare Institute
9:00 AM
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A Confirmatory Basket Trial Design for Multiple Tumor Types Based on Conditional Power
Huiling Li; Jianming Wang, Celgene Corporation; Yeongjin Gwon, University of Connecticut; Xiaolong Luo, Celgene Corporation
9:05 AM
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Discovering Biomarkers Jointly Modeled with Multiple Efficacy Variables in Early Phase Clinical Trials
Danni Yu, Eli Lilly and Company
9:10 AM
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Design Considerations in Clinical Trials with Cure Rate Survival Data: a Case Study in Oncology
Grace Liu, Johnson & Johnson; Steven Sun, J&J; Tzu-min Yhe, janssen pharmaceuticals; Tianmeng Lyu, University of Minnesota; Rao Sudhakar, janssen pharmaceuticals; Bruce Xue, Johnson & Johnson China
9:20 AM
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A Model-Based Conditional Power Assessment for Decision Making in Randomized Controlled Trial Studies
Baiming Zou, University of Florida; Jianwen Cai, University of North Carolina; Gary G. Koch, University of North Carolina; Haibo Zhou, University of North Carolina; Fei Zou, University of North Carolina at Chapel Hill
9:20 AM
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Multiplicity Adjustment for Multiple Endpoints Testing in Overall and Subgroup Populations
Libo Sun, Janssen Pharmaceutical R&D; Grace Liu, Johnson & Johnson; Rui Qin, Janssen Pharmaceutical R&D
9:35 AM
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A Case Study of a Bayesian Adaptive Dose-Finding Phase 2 Trial Design Using Go/No-Go Criteria and Adaptive Randomization
Ye Ting Du; James Bolognese, Cytel Inc
9:35 AM
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Performance Comparison of Post-Hoc Subgroup Search Algorithms for Clinical Trials
Victor Talisa, University of Pittsburgh; (Joyce) Chung-Chou H. Chang, University of Pittsburgh
9:40 AM
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Statistical Leadership in Clinical Trials: Opportunities from the Draft Estimand Guidance
Jonathan Siegel, Bayer HealthCare Pharmaceuticals Inc.
9:50 AM
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Basket Trials Design and Analysis in Non-Oncology Therapeutical Areas
Binbing Yu, MedImmune/AstraZeneca; Jingjing Chen, Takeda Pharmaceuticals; Dewei She, MedImmune/AstraZeneca; Jianliang Zhang, Medimmune, LLC
9:50 AM
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Real-Time Study Milestone Projection in Clinical Trials with Time-To-Event Endpoints
Yanping Liu, Merck & Co.; Gang Jia, Merck & Co.
9:50 AM
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Safety Analysis of Clinical Trials in NDA Submissions
Linyun Zhou, Takeda Global Research & Development
10:05 AM
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On the Relationship Between the Causal-Inference and Meta-Analytic Paradigms for the Evaluation of Surrogate Endpoints
Geert Molenberghs, Universiteit Hasselt & Katholieke Universiteit Leuven
10:35 AM
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Some T-Tests for N-Of-1 Trials with Serial Correlation
Ji-Ling Tang, University of Arkansas for Medical Sciences; Reid D. Landes, University of Arkansas for Medical Sciences; Anne Holbrook, McMaster University; Mark S Mennemeier, University of Arkansas for Medical Sciences; J. Tyler Floyd, University of Central Arkansas
10:35 AM
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Reversals in Early Phase Dose Finding Trials
Bethany Horton, University of Virginia; John O'Quigley, Universit'e Pierre et Marie Curie, ; Mark Conaway, University of Virginia
10:35 AM
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Some T-Tests for N-Of-1 Trials with Serial Correlation: Correction Factors for Trials with Few Observations
Reid D. Landes, University of Arkansas for Medical Sciences; Ji-Ling Tang, University of Arkansas for Medical Sciences; Mark S Mennemeier, University of Arkansas for Medical Sciences; J. Tyler Floyd, University of Central Arkansas; Anne Holbrook, McMaster University
10:40 AM
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A Robust Approach to Sample Size Calculation in Cancer Immunotherapy Trials with Delayed Treatment Effect
Ting Ye, University of Wisconsin-Madison; Menggang Yu, University of Wisconsin-Madison
10:55 AM
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Limitations of Progression Free Survival as a Surrogate Marker for Overall Survival in Oncology Trials
Robin Mogg, Merck Research Laboratories; Yiwei Zhang, Merck Research Laboratories
11:15 AM
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Statistical Ethics and Challenging Substantial Errors in Statistical Methods and Results in a Prominent Peer Reviewed Economics Journal
Chris Barker, Statistical Planning and Analysis Services, Inc.
11:20 AM
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The Impact of Misspecification of Linear Modeling on the Prediction in SMART PK/PD Clinical Trials
Tian Zhao, Merck; Li Fan, Merck
11:20 AM
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Multiple Testing Procedure Consideration in Clinical Trials
Rachael Wen, Sanofi
11:30 AM
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Estimation of Treatment Effect in Enriched Clinical Trials: Application to Multiple Sclerosis
Rachel MacKay Altman, Simon Fraser University
11:35 AM
|
Identifying and Validating Surrogate Endpoints for Overall Survial (OS) in Metastatic Castration-Resistant Prostate Cancer
Xiaowei Guan, Pfizer, Inc.; Michelle Casey, Pfizer, Inc.; De Phung, Astellas Pharma, Inc. ; Suha Sari, Pfizer, Inc.; Eren Demirhan, Pfizer, Inc.
11:35 AM
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Statistical Graphics in Drug Development: Dose-Finding to Dossier Submission
Suddhasatta Acharyya, Novartis pharmaceuticals corporation
11:50 AM
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Biomarker-Defined Subgroup Selection Adaptive Design for Phase III Confirmatory Trial
Rui Tang, Shire; Xiaoye Ma, University of Minnesota; Hui Yang, Amgen Inc.
11:50 AM
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Estimating Directed Acyclic Graphs from High-Dimensional Data and Its Application in Biomarker Discoveries in Early Clinical Trials
Hua Zhong, New York University; Jaehong Yu, NYU School of Medicine
11:55 AM
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Integrating Data from Clinical Trials for More Powerful Mediation and Interaction Analyzes
Linda Valeri, McLean Hospital, Harvard Medical School; Yiwen Zhu, Massachussetts General Hospital; Franca Centorrino, McLean Hospital; Garrett Fitzmaurice, McLean Hospital
11:55 AM
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AAA: Triple-Adaptive Bayesian Designs for the Identification of Optimal Dose Combinations in Dual-Agent Dose-Finding Trials
Jiaying Lyu, University of Chicago; Fudan University; Yuan Ji, NorthShore Univ. HealthSystem / The University of Chicago
11:55 AM
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Design Considerations When Comparing Control, Treatment, and Treatment Plus in Randomized Trials
Abigail Shoben, Ohio State University
12:05 PM
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Choosing the Primary Efficacy Analysis for a Randomized Clinical Trial with Competing Risks
Eric Leifer, National Heart, Lung, and Blood Institute; James Troendle, National Institutes of Health; Lauren Kunz, National Heart, Lung, and Blood Institute
2:05 PM
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Dose Finding Model Selection in Oncology Combination Therapy
Lixia Pei, Janssen Pharmaceuticals ; Yichen Guo, Harvard University; Kevin Liu, Janssen Pharmaceuticals
2:20 PM
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General Regression Model for the Subdistribution of a Competing Risk Under Left-Truncation and Right-Censoring
Anna Bellach, Fred Hutch Cancer Research Center; Michael Kosorok, University of North Carolina at Chapel Hill; Peter Gilbert, Fred Hutchinson Cancer Research Center; Jason P Fine, University of North Carolina at Chapel Hill
2:35 PM
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Testing Strategy in Phase 3 Trials with Multiple Doses
David Li, Pfizer; Simon Kirby, Pfizer
2:35 PM
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Assessing Individual and Disseminated Causal Package Effects in Network HIV Treatment and Prevention Trials
Ashley Buchanan, University of Rhode Island; Donna Spiegelman, Harvard T.H. Chan School of Public Health; Sten Vermund, Yale University; Samuel Friedman, National Development and Research Institutes, Inc.; Judith Lok, Harvard T.H. Chan School of Public Health
2:45 PM
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Analysis of Stratified Clinical Trials with Time-To-Event Endpoints
Devan V Mehrotra, Merck & Co., Inc.; Shanjun Helian, Merck & Co., Inc.; Shu-Chih Su, Merck Research Labs
3:05 PM
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Reproducibility of FDG-PET Standardized Uptake Value (SUV) for Use as an Integral Biomarker in Clinical Trials
Brenda Kurland, University of Pittsburgh
3:05 PM
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A Bayesian Hierarchical Model Estimating CACE in Meta-Analysis of Randomized Clinical Trials with Noncompliance
Jincheng Zhou, University of Minnesota; Haitao Chu, University of Minnesota Twin Cities; James S. Hodges, University of Minnesota; M. Fareed Khan Suri, University of Minnesota
3:25 PM
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Improving the Standards for Reporting of Clinical Trial Data
Jitendra Ganju, Consultant
3:35 PM
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Wednesday, 08/01/2018
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Small Data, N-of-1 Trials, and Personalized Medicine
Naihua Duan, Columbia University; Richard L. Kravitz, University of California Davis
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Propensity Score Methods for Merging Observational and Experimental Data Sets
Evan Taylor Ragosa Rosenman, Stanford University; Art Owen, Stanford University; Michael Baiocchi, Stanford University
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When Do We Really Need Randomized Clinical Trials?
Christopher Hane, OptumLabs; William Crown, OptumLabs
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Allele Specific Information in Mendelian Randomization
Xuran Wang, University of Pennsylvania; Nancy Zhang, University of Pennsylvania; Dylan Small, University of Pennsylvania; Mingyao Li, University of Pennsylvania
|
Practical Guidelines and User-Friendly Software for Bayesian Adaptive Designs
J. Jack Lee, Univ of Texas-M D Anderson Cancer Center
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MMRM Estimates Consideration for Longitudinal Data in Clinical Trials
Yaohua Zhang, Vertex Pharmaceuticals; Zheng (Jason) Yuan, Vertex Pharmaceuticals; Chenkun Wang, Vertex Pharmaceuticals; Bingming Yi, Vertex Pharmaceuticals
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Further Extensions of the Two-Stage Randomized Trial Design for Testing Treatment, Self-Selection and Treatment Preference Effects to Include Count Outcomes
Denise Esserman, Yale University; Yu Shi, Yale University
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Sample Size Estimation for Stratified Cluster Randomized Trials with Binary Outcomes
Lee Kennedy-Shaffer, Harvard University; Michael David Hughes, Harvard University
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Sample Size Formulae and Application for the Two-Stage Continual Reassessment Method (CRM)
Cody Chiuzan, Columbia University; Ying Kuen Ken Cheung, Columbia University; Zilan Chai, Columbia University
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Statistical Considerations of Single Pivotal Vs Two Replicated Confirmatory Studies
Zijiang Yang, Janssen R&D
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Reducing the Effects of Misclassification in Sequential Multiple Assignment Randomized Trials (SMART)
Jun He, Virginia Commonwealth University; Donna McClish, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University
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Single Item Analysis of Patient-Reported Outcome Measures in a Phase III Randomized Controlled Trial
Stacie Hudgens, Clinical Outcome Solutions; Lysbeth Floden, Clinical Outcome Solutions
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A Two-Stage, Phase II Clinical Trial Design with Nested Criteria for Early Stopping and Efficacy: Expected Trial Duration and Tools for Planning
Michelle DeVeaux, Regeneron Pharmaceuticals; Michael John Kane, Yale University; Daniel Zelterman, Yale University
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Small Data and N-of-1 Trials: Developing Personalized Biostatistics for Personalized Medicine and Individualized Health Care Delivery
Christopher Schmid, Brown University; Deborah Estrin , Cornell Tech; Ying Kuen Ken Cheung, Columbia University; Mark Drangsholt, University of Washington; Richard L. Kravitz, University of California Davis; Xiao-Li Meng, Harvard University
8:35 AM
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Subgroup Selection in Adaptive Signature Designs of Confirmatory Clinical Trials
Zhiwei Zhang, University of California at Riverside
8:35 AM
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Moving Beyond Longrank/Hazard Ratio Test/Estimation Approach in Cancer Clinical Trials
Hajime Uno, Dana Farber Cancer Institute; Miki Horiguchi, Kitasato University
8:35 AM
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Sample Size Allocation in Multi-Regional Equivalence Studies
Jason Liao, Merck & Co. Inc.; Ziyi Yu, Jazz Pharmaceuticals Inc; Yulan Li, Myovant Sciences
8:50 AM
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Incorporating Intermediary Information in Cox Models of Randomized Clinical Trials: The Information Balanced Intermediary Cox Model
James Troendle, National Institutes of Health; Eric Leifer, National Heart, Lung, and Blood Institute; Lauren Kunz, National Heart, Lung, and Blood Institute; Song Yang, NHLBI/NIH
8:50 AM
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Estimating Event Rate Differences Using Data from Blinded Trials
A. Gould, Merck Research Laboratories; Bill Wang, Merck
8:55 AM
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Sample Size Formulae and Application for the Two-Stage Continual Reassessment Method (CRM)
Cody Chiuzan, Columbia University; Ying Kuen Ken Cheung, Columbia University; Zilan Chai, Columbia University
8:55 AM
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Single Item Analysis of Patient-Reported Outcome Measures in a Phase III Randomized Controlled Trial
Stacie Hudgens, Clinical Outcome Solutions; Lysbeth Floden, Clinical Outcome Solutions
9:00 AM
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MMRM Estimates Consideration for Longitudinal Data in Clinical Trials
Yaohua Zhang, Vertex Pharmaceuticals; Zheng (Jason) Yuan, Vertex Pharmaceuticals; Chenkun Wang, Vertex Pharmaceuticals; Bingming Yi, Vertex Pharmaceuticals
9:15 AM
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REMAP-CAP: a Precision Medicine Embedded Platform Trial for Community Acquired Pneumonia
Scott Berry, Berry Consultants
9:15 AM
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Multiplicity for a Group Sequential Trial with Biomarker Subpopulations
Jing Zhao, Merck
9:20 AM
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Further Extensions of the Two-Stage Randomized Trial Design for Testing Treatment, Self-Selection and Treatment Preference Effects to Include Count Outcomes
Denise Esserman, Yale University; Yu Shi, Yale University
9:20 AM
|
Different Causes of Missing Values in a Randomized Clinical Trial of Kidney Decline: Implications for the Statistical Analysis Plan
Andrzej Galecki, University of Michigan; Cathie Spino, University of Michigan; Alessandro Doria, Joslin Diabetes Center; Michael Mauer, University of Minnesota
9:20 AM
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Sample Size Estimation for Stratified Cluster Randomized Trials with Binary Outcomes
Lee Kennedy-Shaffer, Harvard University; Michael David Hughes, Harvard University
9:30 AM
|
Assessing Pharmacokinetic Marker Correlates of a Failure Time Outcome, with Application to HIV Prevention Efficacy Trials
Peter Gilbert, Fred Hutchinson Cancer Research Center; Lily Zhang, Fred Hutchinson Cancer Research Center; Erika Thommes, Fred Hutchinson Cancer Research Center; Yunda Huang, Fred Hutchinson Cancer Research Center
9:35 AM
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Controlling the Family-Wise Type I Error Rate in a Phase II POC Trial of the Merck Pneumococcal Vaccine Program: An Application of the Hochberg Approach
Jianing Li, Merck Research Lab
9:35 AM
|
A Curtailed Two-Stage Selection and Testing Procedure for Comparative Clinical Trials
Mingyue Wang, Syracuse University; Pinyuen Chen, Syracuse University
9:35 AM
|
Weighted Log-Rank Test for Time-To-Event Data in Immunotherapy Trials with Random Delayed Treatment Effect and Cure Rate
Shufang Liu, Astellas Pharma; Chenghao Chu, Indiana University, Fairbanks School of Public Health; Alan Rong, Data Science, Astellas Pharma Inc.
9:35 AM
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A Biomarker-Directed Phase 2 Oncology Umbrella Trial to Target Combination Therapy in NSCLC
Hua Ma, Merck; Robin Mogg, Merck Research Laboratories
9:35 AM
|
A Two-Stage, Phase II Clinical Trial Design with Nested Criteria for Early Stopping and Efficacy: Expected Trial Duration and Tools for Planning
Michelle DeVeaux, Regeneron Pharmaceuticals; Michael John Kane, Yale University; Daniel Zelterman, Yale University
9:50 AM
|
Tools and Techniques for Blinded Data Reviews in Ongoing Clinical Trials
Suresh Ankolekar, Cytel Inc.; Hrishikesh Kulkarni, Cytel Inc.
9:55 AM
|
Adaptive Multi-Combination Platform Trials in Oncology; Considerations for Study Designs
Stuart Bailey, Novartis Institutes for Biomed Research; Jennifer Gauvin, Novartis
9:55 AM
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Composite Endpoints in Clinical Trials with Multiple Correlated Dichotomous Outcomes
Boris Zaslavsky, FDA/CBER
10:05 AM
|
Assessment of Treatment Effect on Overall Survival in the Presence of Treatment Switching: a Bridging Approach Across Various Modeling Methods
Yiyun Tang, Pfizer, Inc.; Selaru Paulina, Pfizer Inc.; Xin Huang, Pfizer Inc.
10:05 AM
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Statistical Considerations of Single Pivotal Vs Two Replicated Confirmatory Studies
Zijiang Yang, Janssen R&D
10:05 AM
|
Principal Stratification for Longitudinal Data in Environmental Trials
Joshua Keller, Johns Hopkins Bloomberg School of Public Health; Roger D Peng, Johns Hopkins University
10:05 AM
|
Reducing the Effects of Misclassification in Sequential Multiple Assignment Randomized Trials (SMART)
Jun He, Virginia Commonwealth University; Donna McClish, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University
10:10 AM
|
Evaluating the Statistical Properties of Bayesian Basket Trial Designs
Kristen May Cunanan, Memorial Sloan Kettering Cancer Center; Alexia Iasonos, Memorial Sloan Kettering Cancer Center; Ronglai Shen, Memorial Sloan-Kettering Cancer Center; Colin B Begg, Memorial Sloan Kettering Cancer Center; Mithat Gonen, Memorial Sloan Kettering Cancer Center
10:35 AM
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Novel Model-Assisted Designs for Phase I Drug Combination Trials
Ruitao Lin, MD Anderson Cancer Center
10:35 AM
|
Asymptotic MinP Method for Responder Analysis
Ming Zhou, Bristol-Myers Squibb Company; Mark Donovan, Bristol-Myers Squibb
10:35 AM
|
What Constitutes Scientific Evidence - Controversies in Rare Disease Trial Designs and Personalized Medicine
Mark Chang, Veristat
10:35 AM
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Estimating Probability of Simultaneous Success with Multiple Endpoints Using Truncated Multi-Variate Correlated Normal Distribution
Tianshuang Wu, AbbVie; Yihua Gu, AbbVie; Ziqian Geng, AbbVie; Saurabh Mukhopadhyay, AbbVie
10:50 AM
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A Simulation Study of Consistency Evaluation Between Local and Global Results in Multi-Regional Clinical Trials
Chunsheng He, Bristol-Myers Squibb; Jingyi Lin, Duke University; Stephane Munier, Bristol-Myers Squibb; Shein-Chung Chow, Duke University; Lisa Ying
10:50 AM
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A Statistical Framework on Clinical Trials for Information Integration Across Data Sources with Applications to Rare Disease Clinical Development
Yang Song, Vertex Pharmaceuticals Inc.; Xihao Li, Harvard T.H. Chan School of Public Health
10:55 AM
|
Bayesian Uncertainty Directed Trial Designs
Lorenzo Trippa, Harvard
11:05 AM
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Improving Dose-Finding for Early Oncology Trials with Monotherapy and Combination Therapy
Zhen Zeng, Merck & Co.; Meihua Wang, Merck & Co.; Victoria Plamadeala Johnson, Merck & Co.; Cong Chen, Merck & Co.
11:15 AM
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On Randomized Controlled Trials with Integrated Real World Evidence for Drug Development in Rare Diseases
Qing Liu, Amicus Therapeutics, Inc
11:15 AM
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Comparison of Support Vector Machine and Conformal Inference of in Regression Prediction
Kao-Tai Tsai, Celgene
11:20 AM
|
AAA: Triple-Adaptive Bayesian Designs for the Identification of Optimal Dose Combinations in Dual-Agent Dose-Finding Trials
Yuan Ji, NorthShore Univ. HealthSystem / The University of Chicago; Jiaying Lyu, Fudan Universtiy
11:35 AM
|
Bayes in Drug Development for Rare Diseases
John Scott, FDA
11:35 AM
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How the ICH E9 Addendum Influenced a Phase III Clinical Trial with a Radiographic Endpoint
Ruvie Martin, Novartis Pharmaceuticals
11:50 AM
|
Improving Testing and Description of Treatment Effect in Clinical Trials with Time-To-Event Outcomes
Song Yang, NHLBI/NIH
11:50 AM
|
Degrees of Freedom Adjustment in Mixed Model Repeated Measures Analyzes with Missing Data
Michael McDermott, University of Rochester Medical Center; Madhurima Majumder, Bayer Pharmaceuticals
2:05 PM
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Real World Data Analysis to Inform Clinical Trial Modeling and Simulation
Zhaoling Meng, sanofi; Dimple Patel, sanofi; Qi Tang, Sanofi; Nadia Gaudel-Dedieu, sanofi; James Rogers, Metrum Research Group
2:45 PM
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Approaches to Tipping Point Analyzes for a Binary Endpoint in Longitudinal Clinical Trials
Joseph Wu, Pfizer; Huaming Tan, Pfizer, Inc.; Neal Thomas, Pfizer; Cunshan Wang, Pfizer, Inc.
2:50 PM
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Real-Time, Within-Person Randomization Using a Bandit Algorithm in a Clinical Trial
Susan Murphy, Harvard University
2:55 PM
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Network Meta-Analysis for N-Of-1 Trials with Ordinal Outcomes
Youdan Wang, Brown University; Christopher Schmid, Brown University
3:05 PM
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Handling Missing Not at Random Data for Safety Endpoint in the Multiple Dose Titration Clinical Pharmacology Trial
Li Fan, Merck; Tian Zhao, Merck; Patrick Larson, Merck
3:20 PM
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The Application of Tipping Point Analysis in Clinical Trials
HONG DING
3:35 PM
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Hydraulic Fluids: a Case Study of a Split-Plot Experiment
Jennifer Kensler, Shell
3:35 PM
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Thursday, 08/02/2018
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Dynamic Treatment Regimens for Superbug Infections
Dean Follmann, NIAID
8:35 AM
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A Non-Parametric Statistical Test of Null Treatment Effect in Sub-Populations
Lin Taft, GSK; Changyu Shen, Beth Israel Deaconess Medical Center, Harvard Medical School
8:35 AM
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Impact of Clinical Center Effects on Objective Response Rate
Fang Liu, Merck & Co., Inc; Cong Chen, Merck & Co.
8:35 AM
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Retrospective Matched-Pairs Analysis for Clinical Trial Patient Level Data: a Simulation Study and General Considerations
Bingxia Wang, Takeda Pharmaceuticals Inc.; Chenchen Ma; Yanyan Zhu, Takeda Pharmaceuticals; Guohui Liu, Takeda Pharmaceuticals Inc
8:35 AM
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Utilization of Historical Data and Real World Evidence in Clinical Trial Development - Case Studies in Rare Disease and Oncology
Florence H Yong, Pfizer Inc.; Ray Li, Pfizer Inc.; Steven Y Hua, Celgene - Receptos; Jeffery Palmer, Pfizer Inc.; Roberto Bugarini, Pfizer Inc.
8:50 AM
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Inference for Clinical Trials That Rely on Historical Data: a Review of Statistical Approaches for Reducing Risk of Bias
Lei Nie, Division of Biometrics V, office of Biostatistics, CDER/FDA; James Signorovitch, Analysis Group; Rajeev Ayyagari, Analysis Group
8:55 AM
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Does it Pay to Repeat the Baseline?
Shiyang Ma, University of Rochester; David Oakes , University of Rochester
9:05 AM
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An Overview of Matching Adjusted Indirect Comparisons in Single Arm Clinical Trials with Practical Recommendations and Potential Challenges
Dawn Odom, RTI Health Solutions; Molly Purser, RTI Health Solutions; Lawrence Rasouliyan, RTI Health Solutions
9:15 AM
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Pragmatic Benefit:Risk Evaluation: Healthy Disruption for Clinical Trials
Scott Evans, Harvard University; Ying Liu, Harvard University; Dean Follmann, NIAID
9:35 AM
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Mediation Analysis with Item Response Theory Model for Ordinal Variables: An Application to a Hypothetical Clinical Trial
Yun Zhang, Janssen Research & Development, LLC; Xiang Li, Statistics and Decision Sciences, Janssen Research & Development, LLC; Pilar Lim, Janssen Research & Development, LLC
9:35 AM
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Statistical Challenges and Opportunities in Drug Development for Rare Diseases
Guowen Sun, BioMarin; Keith Gregg, BioMarin; Peter Slasor, BioMarin; Chito Hernandez, BioMarin Pharmaceutical Inc.
9:50 AM
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Uncontrolled Studies and Health Technology Appraisal ? The Need for Methods, Modeling, and Further Research
Anthony Hatswell, University College London
9:55 AM
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Bayesian Extrapolation in Pediatric Clinical Trials
Mehreteab F Aregay, Novartis; David Ohlssen, Novartis; Heinz Schmidli, Novartis Pharamceutical Corporation
10:05 AM
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Optimal Treatment Recommendation via Subgroup Identification in Randomized Control Trials
Yang (Grace) Zhao, Gilead Sciences; Haoda Fu, Eli Lilly and Company
10:05 AM
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Evaluating Biomarkers for Prognostic Enrichment of Clinical Trials
Kathleen F. Kerr, University of Washington; Jeremy Roth, University of Washington; Kehao Zhu, Axio Research; Heather Thiessen-Philbrook, Yale University; Allison Meisner, Johns Hopkins University; Francis Perry Wilson, Yale University; Steven Coca, Icahn School of Medicine at Mount Sinai; Chirag Parikh, Yale University
10:35 AM
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A Simulation Study Comparing MCP-Mod and a Model-Based Approach in Phase 2a Clinical Trials
Hongtao Zhang; Alan Hartford, AbbVie Inc
10:35 AM
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Quantitative Assessment of Risk with Subgroup Pursuit in Clinical Trials
Xinzhou Guo, University of Michigan; Xuming He, University of Michigan
10:35 AM
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A Bayesian Adaptive Phase 1/2 Design of Cisplatin and Cabazitaxel in Prostate Cancer with Visceral Metastasis
Mourad Tighiouart, Cedars-Sinai Medical Center
10:35 AM
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Using an Estimand Approach in Your Next Clinical Trial
Frank Bretz, Novartis Pharma AG; Steven Gilbert, Pfizer; Douglas S. Lee, Pfizer; Jared Christensen, Pfizer; Macaulay Okwuokenye, Syros Pharmaceuticals Inc
10:35 AM
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Competing Effects of Indirect Protection and Clustering on the Power of a Cluster-Randomized Controlled Vaccine Trial
Matthew Hitchings, Harvard School of Public Health
10:35 AM
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Adaptive Bayesian Interval-Based Oncology Dose Finding Design with Quasi-Continuous Toxicity Model
Dan Zhao, University of Illinois at Chicago; Jian Zhu, Takeda; Eric Westin, ImmunoGen; Ling Wang, Takeda
10:50 AM
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Using Surrogate Biomarker Information to Plan a Future Clinical Trial
Layla Parast, RAND; Tianxi Cai, Harvard T.H. Chan School of Public Health; Lu Tian, Stanford University School of Medicine
11:00 AM
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IMP: Interference Manipulating Permutations
Michael Baiocchi, Stanford University; Eric Jay Daza, Stanford University
11:00 AM
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Bias-Corrected Estimation of Treatment Effects in Biomarker-Based Adaptive Subgroup Analysis: New Approach Based on Randomized Tests with Smooth Rejection Function
Kiichiro Toyoizumi, Shionogi Inc.; Shigeyuki Matsui, Nagoya University
11:05 AM
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Detoxing Toxicity Analysis: Creating Analysis-Ready One-Proc Away ADLB
Ilya Krivelevich, Eisai; Ran Xie, Eisai Inc; Simon Lin, Eisai Inc
11:05 AM
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Deriving and Analyzing Endpoints from Electronic Health Record Data: a Case Study from Clinical Oncology
Sandra Griffith, Flatiron Health; Ariel Bourla, Flatiron Health; Bryan Bowser, Flatiron Health ; Geoff Calkins, Flatiron Health; Joe Chang, Flatiron Health; Rebecca Miksad , Flatiron Health ; Brian Segal, Flatiron Health; Elizabeth Sweeney, Flatiron Health ; Erin Williams, Flatiron Health ; Paul You , Flatiron Health ; Amy Abernethy, Flatiron Health
11:15 AM
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Using Hierarchical Models to Estimate Subgroup Effects in a Clinical Trial
Anna McGlothlin, Berry Consultants
11:15 AM
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Practical Considerations of Subgroups Quantification, Selection and Adaptive Enrichment in Confirmatory Trials
Jianchang Lin, Takeda Pharmaceuticals; Rachael Liu, Takeda Pharmaceuticals ; Veronica Bunn, Florida State University
11:20 AM
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On Evaluation of Consistency in Multi-Regional Clinical Trials
Lisa Ying; Fuyu Song, Center for Food and Drug Inspection, cFDA; Shein-Chung Chow, Food and Drug Administration; Na Zeng, National Clinical Research Center for Digestive Diseases, Beijing Friendship Hospital; Jiayin Zheng, Fred Hutchinson Cancer Research Center; Xiaodong Li, Bristol-Myers Squibb Company; David Henry, Bristol-Myers Squibb Company; Venkat Sethuraman, ZS Associates
11:35 AM
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An Adaptive Dose Selection Case Study: Statistical Methods and Operational Considerations
Adam Hamm, Cytel, Inc.
11:35 AM
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Marginal Meta-Analysis for Combining Multiple Randomized Clinical Trials with Rare Events
Yi Huang, University of Maryland, Baltimore County; Elande Baro, US FDA; Yun-Ju Cheng, University of Maryland, Baltimore County; Guoxing Song, US FDA
11:35 AM
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Statistical Arguments for Regulatory Negotiation on Promising Subgroup Results
Ming-Xiu Hu, Nektar Therapeutics
11:35 AM
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Evaluating the Ability of a Biomarker to Improve the Diagnosis of Malaria Infection in Malaria 'Challenge' Trials
Holly Janes, Fred Hutchinson Cancer Research Center
11:50 AM
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Interference and Noncompliance in Clustered Randomized Trials for Program Evaluation
Hyunseung Kang, University of Wisconsin - Madison; Luke Keele, Georgetown University
11:50 AM
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Statistical Monitoring of Semi-Competing Risk Outcomes in Clinical Trials
Toshi Hamasaki; Scott Evans, Harvard University; Tomoyuki Sugimoto, Kagoshima University; Koko Asakura, National Cerebral and Cardiovascular Center; Susan Halabi, Duke University
11:50 AM
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Understand International Differences in Treatment Effect
Li Chen, Amgen
11:55 AM
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