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Keyword Search Criteria: clinical trial returned 29 record(s)
Sunday, 07/29/2018
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

Real World Evidence Demonstration Projects and Policy Development at FDA
Diqiong Xie, FDA; David Barrett Martin, FDA CDER OMP
4:45 PM

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

Monday, 07/30/2018
Standard Analyses and Displays for Common Clinical Trial Data: An Industry-Wide Initiative
Mercidita Navarro, Genentech


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

Tuesday, 07/31/2018
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


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


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


Clinical Trial Data Transparency and Patient Privacy
Darcy Hille, Merck & Company Inc; T. Ceesay, Merck ; Jonathan Hartzel, Merck


Multiple Testing Procedure Consideration in Clinical Trials
Rachael Wen, Sanofi


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


Desirability Functions for Evaluating Clinical Trial Design Quality
Priscilla K Yen, UCLA; Weng Kee Wong, UCLA
8:50 AM

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

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

Multiple Testing Procedure Consideration in Clinical Trials
Rachael Wen, Sanofi
11:30 AM

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

Improving the Standards for Reporting of Clinical Trial Data
Jitendra Ganju, Consultant
3:35 PM

Wednesday, 08/01/2018
Practical Guidelines and User-Friendly Software for Bayesian Adaptive Designs
J. Jack Lee, Univ of Texas-M D Anderson Cancer Center


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


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


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

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

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

Comparison of Support Vector Machine and Conformal Inference of in Regression Prediction
Kao-Tai Tsai, Celgene
11:20 AM

How the ICH E9 Addendum Influenced a Phase III Clinical Trial with a Radiographic Endpoint
Ruvie Martin, Novartis Pharmaceuticals
11:50 AM

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

Thursday, 08/02/2018
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

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