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Keyword Search Criteria: Trial Design returned 23 record(s)
Sunday, 07/29/2018
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

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

Monday, 07/30/2018
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

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

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

Considering Delayed Treatment Effect in Trial Designs with Survival Endpoints
Kaushal Mishra, Novartis Oncology Pharmaceuticals; Kalyanee Viraswami Appanna, Novartis Pharmaceuticals
2:20 PM

Tuesday, 07/31/2018
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


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

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

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

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

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

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

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

What Constitutes Scientific Evidence - Controversies in Rare Disease Trial Designs and Personalized Medicine
Mark Chang, Veristat
10:35 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

Bayesian Uncertainty Directed Trial Designs
Lorenzo Trippa, Harvard
11:05 AM

Thursday, 08/02/2018
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

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

Understand International Differences in Treatment Effect
Li Chen, Amgen
11:55 AM