JSM 2016 Online Program

Keyword Search

Sessions Were Renumbered as of May 19.

Legend:
CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Keyword Search Criteria: Clinical trial returned 153 record(s)

Sunday, 07/31/2016

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

Choosing Estimands in Clinical Trials with Missing Data
Craig Mallinckrodt, Eli Lilly and Company
2:05 PM

Comparison of Methods to Deal with Separation Problem in Clinical Trials with Binary Data
Shuyan Wan, Merck
2:20 PM

Accuracy Measures for Predictive Biomarkers
Richard Macey Simon, National Cancer Institute
2:25 PM

A Decision-Theoretic Comparison of Treatments to Resolve Air Leaks After Lung Surgery Based on Nonparametric Modeling
Yanxun Xu; Peter F. Thall, MD Anderson Cancer Center; Peter Mueller, The University of Texas at Austin; Reza Mehran, MD Anderson Cancer Center
2:25 PM

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

Efficiency of N-of-1 Studies in Cystic Fibrosis Research
Michele Shaffer, Seattle Children's Research Institute; Nicole Mayer-Hamblett, Seattle Children's Research Institute
2:35 PM

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

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

Bayesian Group Sequential Clinical Trial Design Using Total Toxicity Burden and Progression-Free Survival
Brian Hobbs, MD Anderson Cancer Center; Peter F. Thall, MD Anderson Cancer Center; Steven H. Lin, MD Anderson Cancer Center
2:45 PM

Crossover Design and Its Application in Late-Phase Diabetes Studies
Tao Wang; James Malone, Eli Lilly and Company; Haoda Fu; Cory Heilmann, Eli Lilly and Company; Yongming Qu, Eli Lilly and Company; William Huster, Eli Lilly and Company
3:05 PM

A Decision-Theoretic Phase I-II Design for Ordinal Outcomes in Two Cycles
Juhee Lee, University of California at Santa Cruz; Peter F. Thall, MD Anderson Cancer Center; Peter Mueller, The University of Texas at Austin; Yuan Ji, The University of Chicago
3:05 PM

Sensitivity Analyses to Assess the Missing-at-Random Assumption
Shailaja Suryawanshi, Merck; Anjela Tzontcheva, Merck; Raymond Lam, Merck; Gregory Golm, Merck
3:20 PM

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

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

Combining Safety and Efficacy Data for Assessing Risk Benefit in Cancer Clinical Trials: Some Recent Examples
Thomas Kelleher, Bristol-Myers Squibb
4:05 PM

Comparing Parametric and Semiparametric Bayesian Models for Subgroup Analysis in Clinical Trials
Margaret Gamalo-Siebers, Eli Lilly and Company
4:20 PM

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

Bayesian Clinical Trial Design for Survival Studies with Historical Study Data Under a Proportional Hazards Assumption
Matthew Psioda, The University of North Carolina at Chapel Hill; Joseph G. Ibrahim, The University of North Carolina at Chapel Hill
4:35 PM

Continuous Event Monitoring via a Bayesian Predictive Approach
Jianing Di, Janssen R&D; Daniel Wang, Janssen R&D; Robert Brashear, Janssen R&D; Vlad Dragalin, Janssen; Michael Krams, Janssen R&D
4:45 PM

Falsification of Epidemiological Models from Ongoing Clinical Trials
Sayan Dasgupta, Fred Hutchinson Cancer Research Center; Jim P. Hughes, University of Washington
4:50 PM

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

Enrollment and Event Prediction for Blinded Clinical Trials
Hrishikesh Kulkarni, Cytel; Yannis Jemiai, Cytel
5:05 PM

Regulatory Challenges in Evidence Synthesis in Cancer Clinical Trials
Rajeshwari Sirdhara, FDA
5:05 PM

Comparing Novel Approaches to Subgroup Analysis in Early-Phase Clinical Trials
Marius Thomas, Novartis; Björn Bornkamp, Novartis
5:20 PM

Monday, 08/01/2016

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

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

Comparison Between Continuous- and Discrete-Dose EWOC Designs
Marcio Diniz, Cedars-Sinai Medical Center; Mourad Tighiouart, Cedars-Sinai Medical Center; Andre Rogatko, Cedars-Sinai Medical Center

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

Best Practices for Interim Analysis in Clinical Trials
Jiang Hu, FDA

The Impact of Regional Baseline Variation on the Type I Error and Power of Multiregional Clinical Trials
Weining Robieson, AbbVie; Jun Zhao, AbbVie

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

An Extension of Clinical Trial Assurance to a Setting of Multiple Unknown Parameters in a Single-Arm Binomial Trial
Yizhou Jiang, Kite Pharma; Lynn Navale, Kite Pharma; Allen Xue, Kite Pharma

Estimating Survivor Average Causal Effect of Dynamic Treatment Regimes in Randomized Cancer Clinical Trial: A Simulation Study
Takuya Kawahara, University of Tokyo; Yutaka Matsuyama, University of Tokyo

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

Internal Pilot Design for Clinical Trials with Repeated Measures
Xinrui Zhang; Yueh-Yun Chi, University of Florida

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

Bayesian Noncomparative Designs to Account for Uncertainty in Historical Response Rates
Francesca Matano, Carnegie Mellon University; Valeria Sambucini, University of Rome "La Sapienza"

A STEPP Forward in Tailoring Treatment: New Research on the STEPP Methodology
Wai-Ki Yip, Dana-Farber Cancer Institute

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

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

The Rapid Enrollment Design for Phase I Clinical Trials
Yunfei Wang, Children's National
8:50 AM

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

Why Can't We Agree on MRCTs?
Joshua Chen, Sanofi Pasteur
9:15 AM

Adjustment for Multiplicity in Clinical Trials: When Is It Necessary and When Is It Not?
Boguang Zhen, FDA
9:15 AM

Multiplicity Adjustment Considerations in Designing a Confirmatory Oncology Clinical Trial with Multiple Endpoints
Di Li
9:20 AM

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

Example-Based Illustrations of Design, Conduct, Analysis, and Result Interpretation of Multi-Regional Clinical Trials
Hui Quan, Sanofi; Xuezhou Mao, Sanofi
9:35 AM

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

Effect of Differential Discontinuations Across Treatment Arms on Survival Estimates in Randomized Clinical Trials
Shanti Gomatam, FDA
9:35 AM

A STEPP Forward in Tailoring Treatment: New Research on the STEPP Methodology
Wai-Ki Yip, Dana-Farber Cancer Institute
10:10 AM

An Integrated Bayesian Posterior Probability with Simon Two-Stage Design for a Randomized Phase II Clinical Trial
Dung-Tsa Chen, Moffitt Cancer Center; Po-Yu Huang, National Chung-Hsing University; Hui-Yi Lin, Louisiana State University Health Sciences Center
10:35 AM

Quantifying Treatment Benefit in Molecular Subgroups to Assess a Predictive Biomarker
Jaya M. Satagopan, Memorial Sloan Kettering Cancer Center; Alexia Iasonos, Memorial Sloan Kettering Cancer Center
10:35 AM

Does the Direction of Scores Matter in Clinical Trials?
Wanjie Sun, FDA; Stella Grosser, FDA/CDER; Yi Tsong, FDA/CDER
10:55 AM

Bayesian Benefit Risk Assessments for Medical Products
Telba Irony, FDA
11:00 AM

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

The Treatment of Missing Data in a Large Cardiovascular Clinical Outcomes Study
Roderick Joseph Little, University of Michigan
11:25 AM

Mixture Model for Radiographic Progression in Psoriatic Arthritis
Bin Dong, Janssen R&D; Jiandong lu, Janssen R&D
11:50 AM

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

Exploring Bayesian Go/No-Go Decision Criteria in Clinical Trials
Rodney Croos-Dabrera, Astellas Pharma; Misun Lee, Astellas Pharma
2:35 PM

An Easy Introduction to Group Sequential Methodology in Clinical Trials
Anthiyur Kannappan, Cytel
2:50 PM

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

Using Clinical Trials to Better Understand Probability Theory
Michael Proschan; Pamela A. Shaw, University of Pennsylvania
3:05 PM

Optimal Borrowing of Historical Control Data in Clinical Trials
Saurabh Mukhopadhyay, AbbVie; Qi Tang, AbbVie; Alan Hartford, AbbVie
3:20 PM

Bayesian Modeling of Phase II Dose-Ranging Clinical Trials
Shu-Yen Ho, PAREXEL
3:35 PM

Never Fit Sequence: The Design and Analysis of Multi-Period Clinical Trials
Hans Hockey, Biometrics Matters Ltd.
3:35 PM

Tuesday, 08/02/2016

Interim Futility Analysis in the Presence of Delayed Effect in Immunotherapy Clinical Trials
Xue Lin

An Application of the Adaptive Bayesian Design for the Delayed Outcomes in a Phase II Clinical Trial
Lei Feng, MD Anderson Cancer Center; Steven H. Lin, MD Anderson Cancer Center; Suyu Liu, MD Anderson Cancer Center

Unmet Medical Needs: Can We Accelerate Drug Approval and Marketing Through Expansion Cohort Trials?
Soumi Lahiri, GlaxoSmithKline; Teri Ashton, GlaxoSmithKline; Ohad Amit, GlaxoSmithKline

Patient-Derived Model Systems: Design Considerations for Pre-Clinical Study
Laila M. Poisson, Henry Ford Health System; Hoon Kim, MD Anderson Cancer Center; Mary Winn, Van Andel Research Institute; David Cherba, Van Andel Research Institute; Claudius Mueller, George Mason University; Emmanuel F. Petricoin, George Mason University; Roeland Verhaak, MD Anderson Cancer Center; Tom Mikkelsen, Henry Ford Health System; Ana deCarvalho, Henry Ford Health System

Covariate Adjustment for Logistic Regression Analysis of Binary Clinical Trial Data
Honghua Jiang; Pandurang Kulkarni, Eli Lilly and Company; Craig Mallinckrodt, Eli Lilly and Company; Linda Shurzinske, Eli Lilly and Company; Geert Molenberghs, Universiteit Hasselt; Ilya Lipkovich, Quintiles

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

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

Innovative Bayesian Applications in Clinical Trials
Soumi Lahiri, GlaxoSmithKline; Satrajit Roychoudhury, Novartis
8:55 AM

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

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

A Bayesian Adaptive Clinical Trial Design: Diagnostic Accuracy of an Olfactory Diagnostic Test for Traumatic Brain Injury in Combat Soldiers
Benjamin Saville, Berry Consultants
10:35 AM

Link-Free Identification of Simple Index Variables for the Prediction of Differential Treatment Response
Hongjie Zhu, Sanofi
11:05 AM

Bias Correction for Biomarker Threshold Studies
Li Liu, Sanofi; Glen Laird, Sanofi
11:50 AM

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

Detecting Treatment Differences in Group Sequential Longitudinal Studies with Covariate Adjustment
Neal Jeffries, National Heart, Lung, and Blood Institute; James Troendle, National Institutes of Health; Nancy L. Geller, National Heart, Lung, and Blood Institute
2:05 PM

Sample Size Estimation Using a Hybrid Classical and Bayesian Procedure
Maria Ciarleglio, Yale University; Christopher Arendt, Air Force Office of Scientific Research
2:20 PM

Case Studies for Biologics Trials in Very Rare Diseases
John Scott, FDA
2:35 PM

Using Power Contours to Assess the Sensitivity of Clinical Trial Design Assumptions
Richard C. Zink, JMP Life Sciences, SAS Institute; Xiaotong Jiang, The University of North Carolina at Chapel Hill
2:35 PM

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

Identifying Main Effects in Multi-Factor Clinical Trials
Abhishek Bhattacharjee, University of Florida; Samuel S. Wu, University of Florida
3:05 PM

Generalized Semiparametric Varying-Coefficient Models for Longitudinal Data
Li Qi, Sanofi US; Yanqing Sun, The University of North Carolina at Charlotte; Peter Gilbert, Fred Hutchinson Cancer Research Center
3:20 PM

Practical Considerations in Clinical Trial Design
Kerry Go, Sanofi Pasteur
3:35 PM

Wednesday, 08/03/2016

Properties of Adaptive Clinical Trial Signature Design in the Presence of Gene and Gene-Treatment Interaction
Alexander Cambon, University of Louisville; Shesh N. Rai, University of Louisville; Guy Brock, University of Louisville

A Web Application for Optimal Selection of Adaptive Designs in Phase I Oncology Clinical Trials
Sheau-Chiann Chen; Yu Shyr, Vanderbilt University

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

Explore Methodologies for Extrapolation of Efficacy from the Adult to the Specific Pediatric Population
Yao Li, AbbVie; Bidan Huang, AbbVie

Statistical Inference of Covariate-Adjusted Response-Adaptive Randomized Clinical Trials
Wanying Zhao, The George Washington University

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

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

A Clinical Trial Design Based on the Concept of Relative Time Using the Generalized Gamma Ratio Distribution
Milind Phadnis, University of Kansas Medical Center

Subgroup Analyses in Early-Phase Clinical Trials: Challenges and Opportunities
Björn Bornkamp, Novartis; Marius Thomas, Novartis
8:35 AM

Statistical Inference of Covariate-Adjusted Response-Adaptive Randomized Clinical Trials
Wanying Zhao, The George Washington University
8:35 AM

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

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

Explore Methodologies for Extrapolation of Efficacy from the Adult to the Specific Pediatric Population
Yao Li, AbbVie; Bidan Huang, AbbVie
9:00 AM

A Clinical Trial Design Based on the Concept of Relative Time Using the Generalized Gamma Ratio Distribution
Milind Phadnis, University of Kansas Medical Center
9:05 AM

Challenges and Experience in Designing Small Clinical Trials
Christopher Coffey, University of Iowa
9:15 AM

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

Improved Group Sequential Clinical Trial Designs with Multiple Co-Primary Endpoints
Koko Asakura, National Cerebral and Cardiovascular Center; Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center; Franz Koenig, Medical University of Vienna; Martin Posch, Medical University of Vienna
9:50 AM

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

Clinical Trial Design of Authorized Biosimilars in Europe
Johanna Mielke, Novartis Pharma AG; Bernd Jilma, Medical University of Vienna; Byron Jones, Novartis Pharma; Franz Koenig, Medical University of Vienna
10:35 AM

The Three Pillars of a Successful Data Monitoring Committee Organizational Meeting and Interim Monitoring of a Randomized Clinical Trial and the Eventual Impact on Public Health
Navneet Ram Hakhu, Axio Research
10:35 AM

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

Boosting the Power of Phase II and III Oncology Studies Using Project Data Sphere
Greg Hather, Takeda; Ray Liu, Takeda
10:55 AM

Various Approaches to Calculate 95% CIs of Treatment Difference from a Stratified Noninferiority Trial
Qiaoyang Lu, Astellas Pharma; Misun Lee, Astellas Pharma
11:05 AM

Facilitating Clinical Trial Simulation in Alzheimer's Disease Using the CAMD IPD, Literature Summary Level Data, and the 'adsim' R Package
Daniel Polhamus, Metrum Research Group
11:15 AM

Bayesian Design of Phase II Noninferiority (NI) Safety Clinical Trial
Lu-May Chiang, Novartis Pharma; David Ohlssen, Novartis; Dong Xi, Novartis
11:20 AM

The Role of Multiple Imputation in Noninferiority Trials
Brian Wiens, Portola Pharmaceuticals; Ilya Lipkovich, Quintiles
11:35 AM

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

Using External Patient Data in Clinical Trial Simulation
Forrest Williamson, Eli Lilly and Company
11:35 AM

Modeling Events and Early Terminations to Predict
John Johnson, PPD
11:50 AM

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

Case Studies in Academic-Industry-Government Collaborations in Bayesian Adaptive Clinical Trials
Bradley Carlin, University of Minnesota
2:05 PM

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

Analyzing Binary Outcome Data from a Partially Clustered Design
Brittney Bailey, The Ohio State University; Abigail Shoben, The Ohio State University
2:20 PM

Testing Treatment Effect in Clinical Trials with Patient Dropout Using Latent Mixture Models
Fanhui Kong, FDA; Yeh-Fong Chen, FDA
2:20 PM

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

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

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

Dual Minimization in Clinical Trials
Jay Taves; Donald Taves, University of Washington
3:35 PM

Thursday, 08/04/2016

Outside the Closed Door: Industry Statisticians Discuss the DMC Process
Paul Gallo, Novartis; Walt Offen, AbbVie; Markus Abt, Roche/Genentech; Gordon Sun, BioMarin; Gary Aras, Amgen
8:35 AM

Efficient Study Designs in Clinical Research
Steven Julious, University of Sheffield
8:35 AM

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

The Impact of Sensitivity and Specificity of Case Definition on Vaccine Efficacy Trial Design
Xiaohua Sheng, Sanofi Pasteur; Steven Self, Fred Hutchinson Cancer Research Center; Ehab Bassily, Sanofi Pasteur; Joshua Chen, Sanofi Pasteur
9:05 AM

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

Subgroup Identification in a Learn-and-Confirm Setting
Lei Shen, Eli Lilly and Company
9:55 AM

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

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

Design Immunotherapy Trials with Delayed Treatment Effect
Zhenzhen Xu, FDA; Boguang Zhen, FDA; Yongseok Park, University of Pittsburgh; BIN ZHU, National Cancer Institute
10:35 AM

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

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

Dealing with Multiplicity Issues in Late-Stage Oncology Trials
Keaven Anderson, Merck; Christine K. Gause, Merck Research Laboratories
10:55 AM

Comparison Beyond Power: Sample Size Re-Estimation vs. Group Sequential Design
Lei Shu, Astellas Pharma; Charles Liu, Astellas Pharma; Matt Rosales, Astellas Pharma
11:05 AM

Weighted Win Ratio Approach
Junshan Qiu, FDA; Steven Bai, FDA; Wei-Yann Tsai, Columbia University; Xiaodong Luo, Sanofi
11:15 AM

Overlap Between Statisticians and Pharmacometricians in Clinical Drug Development: Conflicts and Possible Resolutions
Ken Kowalski, Kowalski PMetrics Consulting
11:15 AM

Using Clustered Historical Borrowing in Clinical Trials
Michelle Detry, Berry Consultants; Kert Viele, Berry Consultants
11:15 AM

Multiple Comparisons in Truncated Group Sequential Experiments with Applications in Clinical Trials
Tian Zhao
11:20 AM

Use of Co-Data in Clinical Trials with Time-to-Event Endpoint
Satrajit Roychoudhury, Novartis
11:35 AM

Joint Modeling of Time-to-Event and Laboratory Test Data
Kao-Tai Tsai
11:35 AM

On Analysis of Longitudinal Clinical Trials with Missing Data Using Reference-Based Imputation
Lei Pang, Merck; Guanghan Liu, Merck Research Laboratories
11:50 AM

How to Decide When to Borrow Historical Data for a Clinical Trial
Qi Tang, AbbVie; Martin King, AbbVie; Ran Liu, AbbVie; Bo Fu, AbbVie; Sandra Lovell, AbbVie; Alan Hartford, AbbVie
11:55 AM

Comparing Randomization Methods for Clinical Trials
Steven Schwager, Medidata Solutions
12:05 PM

JSM 2016 Online Program

Keyword Search

ASA Meetings Department

Share