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* = applied session ! = JSM meeting theme
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Keyword Search Criteria: clinical trials returned 107 record(s)
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Sunday, 07/31/2016
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The Utility of Conditional Autoregressive (CAR) Models for Modeling Efficacy of Molecularly Targeted Agents in Early-Phase Trials
Thomas Braun, University of Michigan
2:05 PM
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Choosing Estimands in Clinical Trials with Missing Data
Craig Mallinckrodt, Eli Lilly and Company
2:05 PM
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Comparison of Methods to Deal with Separation Problem in Clinical Trials with Binary Data
Shuyan Wan, Merck
2:20 PM
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Accuracy Measures for Predictive Biomarkers
Richard Macey Simon, National Cancer Institute
2:25 PM
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Two-Stage Design for Phase I/II Cancer Clinical Trials Using Drug Combinations of Cytotoxic Agents
Mourad Tighiouart, Cedars-Sinai Medical Center; Quanlin Li
2:25 PM
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Incorporation of Historical Information in Bayesian Analysis of Crossover Medical Device Clinical Trials
Youssef Toubouti, Johnson & Johnson Vision Care; Xiwei Chen, Johnson & Johnson Vision Care
2:35 PM
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Role of Simulations in the Selection of the Primary Estimand and Statistical Methods for Handling Missing Data
Elena Polverejan, Janssen R&D
2:45 PM
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Sensitivity Analyses to Assess the Missing-at-Random Assumption
Shailaja Suryawanshi, Merck; Anjela Tzontcheva, Merck; Raymond Lam, Merck; Gregory Golm, Merck
3:20 PM
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Predicting the Timing of the Final Event in a Clinical Trial Using the Bayesian Bootstrap and Beyond
Marc Sobel, Temple University; Ibrahim Turkoz, Janssen R&D
4:05 PM
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Use of Bayesian Approach for the Design and Evaluation of Multiregional Clinical Trials
Chinfu Hsiao, National Health Research Institutes; Yu-Chieh Cheng, National Chiao Tung University; Hsiuying Wang, National Chiao Tung University
4:05 PM
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Combining Safety and Efficacy Data for Assessing Risk Benefit in Cancer Clinical Trials: Some Recent Examples
Thomas Kelleher, Bristol-Myers Squibb
4:05 PM
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Comparing Parametric and Semiparametric Bayesian Models for Subgroup Analysis in Clinical Trials
Margaret Gamalo-Siebers, Eli Lilly and Company
4:20 PM
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Composite Bootstrap Test with Counterintuitive Resampling Method to Compare Two Groups: An Application to Randomized Clinical Trials
Alok Dwivedi, Texas Tech University Health Sciences Center El Paso; Christopher Dodoo, Texas Tech University Health Sciences Center El Paso; Sada Nand Dwivedi, All India Institute of Medical Sciences; Rakesh Shukla, University of Cincinnati
4:35 PM
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Falsification of Epidemiological Models from Ongoing Clinical Trials
Sayan Dasgupta, Fred Hutchinson Cancer Research Center; Jim P. Hughes, University of Washington
4:50 PM
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An Evaluation of Treatment Effect in Opt-In Versus Opt-Out Consent Frameworks Under a Mixture of Participant Motivation Levels
Alessandra Valcarcel, University of Pennsylvania
5:05 PM
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Enrollment and Event Prediction for Blinded Clinical Trials
Hrishikesh Kulkarni, Cytel; Yannis Jemiai, Cytel
5:05 PM
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Regulatory Challenges in Evidence Synthesis in Cancer Clinical Trials
Rajeshwari Sirdhara, FDA
5:05 PM
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Comparing Novel Approaches to Subgroup Analysis in Early-Phase Clinical Trials
Marius Thomas, Novartis; Björn Bornkamp, Novartis
5:20 PM
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Monday, 08/01/2016
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Risk-Based Monitoring Rules for Binomial and Poisson Outcomes in Clinical Trials with Software Implementation in JMP
Anastasia Dmitrienko; Richard C. Zink, JMP Life Sciences, SAS Institute
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Evaluation of Sensitivity of Statistical Methods That Assume Missing at Random
Takayuki Abe, Keio University School of Medicine; Kazuhito Shiosakai, Daiichi Sankyo Co.; Rachel Roberts, Keio University School of Medicine; Fumiya Sano, Keio University School of Medicine; Manabu Iwasaki, Seikei University
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Sample Size and Duration of Study in Clinical Trials with Time-to-Event Endpoint
Ryunosuke Machida, Tokyo University of Science; Yosuke Fujii, Pfizer Japan; Takashi Sozu, Tokyo University of Science
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Best Practices for Interim Analysis in Clinical Trials
Jiang Hu, FDA
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The Impact of Regional Baseline Variation on the Type I Error and Power of Multiregional Clinical Trials
Weining Robieson, AbbVie; Jun Zhao, AbbVie
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A Group Sequential Test of a Competing Risk Endpoint for Treatment Effect Based on the Fine-Gray Model
Michael Martens, Medical College of Wisconsin; Brent Logan, Medical College of Wisconsin
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A Simulation Method Based on Interim Results to Assess Conditional Power in Clinical Trials
Lin Pan, ICON PLC; Jill Stankowski, ICON PLC; Joseph M. Massaro, Boston University
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Internal Pilot Design for Clinical Trials with Repeated Measures
Xinrui Zhang; Yueh-Yun Chi, University of Florida
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Assessment of Effect Size and Power for Survival Analysis Through a Binary Surrogate Endpoint in Clinical Trials
Judah Abberbock, University of Pittsburgh ; Gong Tang, University of Pittsburgh
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Bayesian Noncomparative Designs to Account for Uncertainty in Historical Response Rates
Francesca Matano, Carnegie Mellon University; Valeria Sambucini, University of Rome "La Sapienza"
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Assessing Model Fit in Joint Models of Longitudinal and Survival Data with Applications to Cancer Clinical Trials
Joseph G. Ibrahim, The University of North Carolina at Chapel Hill; Ming-Hui Chen, University of Connecticut; Mark Boye, Eli Lilly and Company; Wei Shen, Eli Lilly and Company; Danjie Zhang, Gilead Pharmaceuticals
8:35 AM
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Bayesian Response-Adaptive Covariate-Adjusted Randomization Design for Clinical Trials
Jianchang Lin, Takeda; LiAn Lin, Merck Research Laboratories; Serap Sankoh, Takeda; Fang Yang, Vertex Pharmaceuticals; Guohui Liu, Takeda
8:50 AM
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The Rapid Enrollment Design for Phase I Clinical Trials
Yunfei Wang, Children's National
8:50 AM
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Design and Analysis of Multiregional Clinical Trials in Evaluation of Medical Devices: Some Points to Consider from a Regional Regulatory Perspective
Yunling Xu, FDA/CDRH; Nelson LU, FDA/CDRH
8:55 AM
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Adjustment for Multiplicity in Clinical Trials: When Is It Necessary and When Is It Not?
Boguang Zhen, FDA
9:15 AM
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Multiplicity Adjustment Considerations in Designing a Confirmatory Oncology Clinical Trial with Multiple Endpoints
Di Li
9:20 AM
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Joint Modeling of Survival Time with Another Outcome in Clinical Trials or Observational Studies
Ross L. Prentice, Fred Hutchinson Cancer Research Center; Shanshan Zhao, National Institute of Environmental Health Sciences
9:25 AM
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Example-Based Illustrations of Design, Conduct, Analysis, and Result Interpretation of Multi-Regional Clinical Trials
Hui Quan, Sanofi; Xuezhou Mao, Sanofi
9:35 AM
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A New Design for Drug Combination in Phase I Dose-Finding Clinical Trials
Jim Xiang, Janssen; Grace Liu, Johnson & Johnson; James Pan, Janssen
9:35 AM
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Effect of Differential Discontinuations Across Treatment Arms on Survival Estimates in Randomized Clinical Trials
Shanti Gomatam, FDA
9:35 AM
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Does the Direction of Scores Matter in Clinical Trials?
Wanjie Sun, FDA; Stella Grosser, FDA/CDER; Yi Tsong, FDA/CDER
10:55 AM
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Bayesian Benefit Risk Assessments for Medical Products
Telba Irony, FDA
11:00 AM
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Comparison of Treatment Effects Between U.S. and Non-U.S. Study Sites in Multiregional Alzheimer's Disease Clinical Trials
Jingyu Luan, FDA; Hsien-Ming James Hung, FDA; Ranjit Mani, FDA
11:05 AM
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Application of Propensity-Score Matching in Data Augmentation of Randomized Clinical Trials: A Case Study
Junjing Lin, AbbVie; Margaret Gamalo-Siebers, Eli Lilly and Company; Ram Tiwari, FDA/CDER/OT/OB
2:20 PM
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Exploring Bayesian Go/No-Go Decision Criteria in Clinical Trials
Rodney Croos-Dabrera, Astellas Pharma; Misun Lee, Astellas Pharma
2:35 PM
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An Easy Introduction to Group Sequential Methodology in Clinical Trials
Anthiyur Kannappan, Cytel
2:50 PM
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Bayesian Bounding of the Population Subgroup Which Benefits from Treatment
Patrick Schnell, University of Minnesota; Qi Tang, AbbVie; Walt Offen, AbbVie; Bradley Carlin, University of Minnesota
3:05 PM
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Using Clinical Trials to Better Understand Probability Theory
Michael Proschan; Pamela A. Shaw, University of Pennsylvania
3:05 PM
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Optimal Borrowing of Historical Control Data in Clinical Trials
Saurabh Mukhopadhyay, AbbVie; Qi Tang, AbbVie; Alan Hartford, AbbVie
3:20 PM
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Bayesian Modeling of Phase II Dose-Ranging Clinical Trials
Shu-Yen Ho, PAREXEL
3:35 PM
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Never Fit Sequence: The Design and Analysis of Multi-Period Clinical Trials
Hans Hockey, Biometrics Matters Ltd.
3:35 PM
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Tuesday, 08/02/2016
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Interim Futility Analysis in the Presence of Delayed Effect in Immunotherapy Clinical Trials
Xue Lin
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Unmet Medical Needs: Can We Accelerate Drug Approval and Marketing Through Expansion Cohort Trials?
Soumi Lahiri, GlaxoSmithKline; Teri Ashton, GlaxoSmithKline; Ohad Amit, GlaxoSmithKline
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Adjusting for Noncompliance in Randomized Clinical Trials When Noncompliance Must Be Estimated from a Biomarker
Jeffrey Boatman; David Vock, University of Minnesota School of Public Health; Joseph S. Koopmeiners, University of Minnesota
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Tumor Response in Patients Receiving No Anti-Cancer Therapy: A Meta-Analysis with Incomplete Multinomial Regression
Charity Morgan, University of Alabama at Birmingham; Pooja Ghatalia, University of Alabama at Birmingham; Guru Sonpavde, University of Alabama at Birmingham
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Innovative Bayesian Applications in Clinical Trials
Soumi Lahiri, GlaxoSmithKline; Satrajit Roychoudhury, Novartis
8:55 AM
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Tumor Response in Patients Receiving No Anti-Cancer Therapy: A Meta-Analysis with Incomplete Multinomial Regression
Charity Morgan, University of Alabama at Birmingham; Pooja Ghatalia, University of Alabama at Birmingham; Guru Sonpavde, University of Alabama at Birmingham
9:05 AM
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Interim Go/No-Go Decision Making in Clinical Trials with Longitudinal Outcomes
Ming Zhou, Bristol-Myers Squibb; Qi Tang, AbbVie; Lixin Lang, Bristol-Myers Squibb; Jun Xing, Bristol-Myers Squibb; Kay Tatsuoka, Bristol-Myers Squibb
9:15 AM
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Bayesian Predictive Approach to Concurrent Tailoring of Phase 3 Clinical Trials Intended for Registration
Ming-Dauh Wang, Eli Lilly and Company; Aijun Gao, inVentiv Health; Jinghui Liu, inVentiv Health; Karen Price, Eli Lilly and Company; MaryAnn Morgan-Cox, Eli Lilly and Company; Lei Shen, Eli Lilly and Company
9:15 AM
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Adjusting for Noncompliance in Randomized Clinical Trials When Noncompliance Must Be Estimated from a Biomarker
Jeffrey Boatman; David Vock, University of Minnesota School of Public Health; Joseph S. Koopmeiners, University of Minnesota
10:05 AM
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Link-Free Identification of Simple Index Variables for the Prediction of Differential Treatment Response
Hongjie Zhu, Sanofi
11:05 AM
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Bias Correction for Biomarker Threshold Studies
Li Liu, Sanofi; Glen Laird, Sanofi
11:50 AM
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Developing PRO Instruments in Clinical Trials: Issues, Considerations, and Solutions
Cheryl Coon, Outcometrix; Dennis Revicki, Evidera; Scott Komo, FDA/CDER; Kendra DeBusk, Genentech; Lisa Kammerman, AstraZeneca; Stacie Hudgens, Clinical Outcome Solutions
2:05 PM
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Hierarchical Bayesian Approaches for Clinical Trials in Orphan and Pediatric Diseases
Cynthia Basu, University of Minnesota; Freda Cooner, FDA/CDER/OTS/OB/DB2; Ram Tiwari, FDA/CDER/OT/OB; Bradley Carlin, University of Minnesota
3:05 PM
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Identifying Main Effects in Multi-Factor Clinical Trials
Abhishek Bhattacharjee, University of Florida; Samuel S. Wu, University of Florida
3:05 PM
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Practical Considerations in Clinical Trial Design
Kerry Go, Sanofi Pasteur
3:35 PM
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Wednesday, 08/03/2016
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A Web Application for Optimal Selection of Adaptive Designs in Phase I Oncology Clinical Trials
Sheau-Chiann Chen; Yu Shyr, Vanderbilt University
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A Simulation-Based Method for Detecting the Best Treatment in Clinical Trials
Yan Zhao, University of Oklahoma Health Sciences Center; Roy Tamura, University of South Florida; Michael Brown, Oklahoma Medical Research Foundation
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Statistical Inference of Covariate-Adjusted Response-Adaptive Randomized Clinical Trials
Wanying Zhao, The George Washington University
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Adaptive Estimation of Personalized Maximum Tolerated Doses in Cancer Phase I Clinical Trials According to All Toxicities and Individual Characteristics
Zhengjia Chen, Emory University; Zheng Li, Penn State University; Ying Yuan, MD Anderson Cancer Center; Michael Kutner, Emory University; Taofeek Owonikoko, Emory University; Walter J. Curran, Emory University; Jeanne Kowalski, Emory University
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Small Sample Inference in Imbalanced Cluster Randomized Clinical Trials with Binary Outcomes
Dong Hyun Ahn, New York University; Judith D. Goldberg, New York University School of Medicine
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Subgroup Analyses in Early-Phase Clinical Trials: Challenges and Opportunities
Björn Bornkamp, Novartis; Marius Thomas, Novartis
8:35 AM
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Statistical Inference of Covariate-Adjusted Response-Adaptive Randomized Clinical Trials
Wanying Zhao, The George Washington University
8:35 AM
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Adaptive Estimation of Personalized Maximum Tolerated Doses in Cancer Phase I Clinical Trials According to All Toxicities and Individual Characteristics
Zhengjia Chen, Emory University; Zheng Li, Penn State University; Ying Yuan, MD Anderson Cancer Center; Michael Kutner, Emory University; Taofeek Owonikoko, Emory University; Walter J. Curran, Emory University; Jeanne Kowalski, Emory University
8:45 AM
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Sample Size Planning for Survival Endpoints in Cardiovascular Clinical Trials
Ququan Liu, FDA/CDER; John Lawrence, FDA/CDER; Hsien-Ming James Hung, FDA
8:50 AM
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Small Sample Inference in Imbalanced Cluster Randomized Clinical Trials with Binary Outcomes
Dong Hyun Ahn, New York University; Judith D. Goldberg, New York University School of Medicine
8:50 AM
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Challenges and Experience in Designing Small Clinical Trials
Christopher Coffey, University of Iowa
9:15 AM
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A Simulation-Based Method for Detecting the Best Treatment in Clinical Trials
Yan Zhao, University of Oklahoma Health Sciences Center; Roy Tamura, University of South Florida; Michael Brown, Oklahoma Medical Research Foundation
9:35 AM
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Multidimensional Latent Trait Linear Mixed Model with an Application in Clinical Trials
Jue Wang, The University of Texas Health Science Center at Houston; Sheng Luo, The University of Texas at Houston
9:50 AM
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Arm Dropping in Clinical Trials: An In-Depth Look at Statistical Considerations and Implications
JonDavid Sparks, Eli Lilly and Company; Brian Millen, Eli Lilly and Company; Qi Zhang, Eli Lilly and Company
10:05 AM
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Group-Sequential Clinical Trials for Comparing Two Interventions Using Two Time-to-Event Outcomes
Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center; Tomoyuki Sugimoto, Hirosaki University; Koko Asakura, National Cerebral and Cardiovascular Center; Scott Evans, Harvard
10:50 AM
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The Role of Multiple Imputation in Noninferiority Trials
Brian Wiens, Portola Pharmaceuticals; Ilya Lipkovich, Quintiles
11:35 AM
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Statistical Issues for Safety Monitoring of Recurrent Adverse Events in Clinical Trials
LiAn Lin, Merck Research Laboratories; Greg Ball, Merck Research Laboratories; William William Wang, Merck Research Laboratories
11:35 AM
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Using External Patient Data in Clinical Trial Simulation
Forrest Williamson, Eli Lilly and Company
11:35 AM
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Modeling Events and Early Terminations to Predict
John Johnson, PPD
11:50 AM
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Collection of Adverse Events Data for the Supplemental Indications in Cancer Clinical Trials: Is It Needed?
Sirisha Mushti, FDA; Huanyu Chen, FDA; Yun Wang, FDA; Rajeshwari Sridhara, FDA
12:05 PM
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Case Studies in Academic-Industry-Government Collaborations in Bayesian Adaptive Clinical Trials
Bradley Carlin, University of Minnesota
2:05 PM
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Factorial Clinical Trials for Hybrid Research Studies
Christine Mauro, Columbia University; Naihua Duan, Columbia University; Katherine Shear, Columbia University; Yuanjia Wang, Columbia University
2:05 PM
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Analyzing Binary Outcome Data from a Partially Clustered Design
Brittney Bailey, The Ohio State University; Abigail Shoben, The Ohio State University
2:20 PM
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Testing Treatment Effect in Clinical Trials with Patient Dropout Using Latent Mixture Models
Fanhui Kong, FDA; Yeh-Fong Chen, FDA
2:20 PM
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Adaptive Dose Modification for Phase I Clinical Trials
Yiyi Chu, The University of Texas School of Public Health; Haitao Pan, MD Anderson Cancer Center; Ying Yuan, MD Anderson Cancer Center
2:35 PM
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Design of Primary and Sensitivity Analyses for Handling Nonfuture Dependence Missing Data in Clinical Trials with an Emphasis on the Type I Error Rate Using Pattern Mixture Model
Lixian Peng, Celgene; Weichung J. Shih, Rutgers University
2:35 PM
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Optimizing Dynamic Treatment Regimes via Quality-Adjusted Q-Learning and Threshold Utility Analysis for Subgroup Analysis in Clinical Trials
Geoffrey Johnson; Andrew Topp, University of Pittsburgh; Abdus S. Wahed, University of Pittsburgh
2:50 PM
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Dual Minimization in Clinical Trials
Jay Taves; Donald Taves, University of Washington
3:35 PM
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Thursday, 08/04/2016
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Efficient Study Designs in Clinical Research
Steven Julious, University of Sheffield
8:35 AM
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Comparison of Some Subgroup Identification Algorithms for Precision Medicine in Drug Development
Xin Huang; Yan Sun, AbbVie; Saptarshi Chatterjee, AbbVie; Viswanath Devanarayan, AbbVie
8:55 AM
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Patient Subgroup Identification in Clinical Trials Where Overall Treatment Response Is Suboptimal
Isaac Nuamah, Janssen R&D; Youping Huang, Janssen R&D
9:50 AM
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Subgroup Identification in a Learn-and-Confirm Setting
Lei Shen, Eli Lilly and Company
9:55 AM
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Deconstructing the Measure of Vaccine Efficacy Against Disease Irrespective of HPV in HPV Vaccine Clinical Trials
Oliver Bautista, Merck; Alain Luxembourg, Merck
10:05 AM
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Bayesian Approach to Design and Analysis of Composite Endpoints in Clinical Trials with Multiple Dependent Binary Outcomes
Boris G. Zaslavsky, FDA/CBER
10:35 AM
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Restricted Mean Survival Time: Does Covariate Adjustment Improve Precision in Randomized Clinical Trials?
Theodore Karrison, The University of Chicago; Masha Kocherginsky, The University of Chicago
10:35 AM
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Utilization of Historical Patient-Level Data for Efficient Trial Design
Zachary Thomas, Eli Lilly and Company; Tianle Hu, Eli Lilly and Company; Nathan Enas, Eli Lilly and Company; Honglu Liu, Eli Lilly and Company
10:55 AM
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Dealing with Multiplicity Issues in Late-Stage Oncology Trials
Keaven Anderson, Merck; Christine K. Gause, Merck Research Laboratories
10:55 AM
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Weighted Win Ratio Approach
Junshan Qiu, FDA; Steven Bai, FDA; Wei-Yann Tsai, Columbia University; Xiaodong Luo, Sanofi
11:15 AM
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Using Clustered Historical Borrowing in Clinical Trials
Michelle Detry, Berry Consultants; Kert Viele, Berry Consultants
11:15 AM
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Multiple Comparisons in Truncated Group Sequential Experiments with Applications in Clinical Trials
Tian Zhao
11:20 AM
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Use of Co-Data in Clinical Trials with Time-to-Event Endpoint
Satrajit Roychoudhury, Novartis
11:35 AM
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On Analysis of Longitudinal Clinical Trials with Missing Data Using Reference-Based Imputation
Lei Pang, Merck; Guanghan Liu, Merck Research Laboratories
11:50 AM
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Comparing Randomization Methods for Clinical Trials
Steven Schwager, Medidata Solutions
12:05 PM
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