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Keyword Search Criteria: phase II returned 20 record(s)
Sunday, 07/29/2018
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

Monday, 07/30/2018
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

Tuesday, 07/31/2018
Use of Modified Risk Function in Drug Intervention Planning
Myung Shin Sim, UCLA


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

A Note on Phase II Single-Arm Two-Stage Designs for Safety
Seongho Kim, Wayne State University; Weng Kee Wong, UCLA
10:50 AM

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

Wednesday, 08/01/2018
A Stagewise Prognostic Control Predictive Approach (SPCPA) for Subgroup Identification and Its Application in a Phase II Study
Wanying Li, Gilead Sciences; Wangshu Zhang, Gilead Sciences; Lovely Goyal, Gilead Sciences; Yuanyuan Xiao, Gilead Sciences


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


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


A Stagewise Prognostic Control Predictive Approach (SPCPA) for Subgroup Identification and Its Application in a Phase II Study
Wanying Li, Gilead Sciences; Wangshu Zhang, Gilead Sciences; Lovely Goyal, Gilead Sciences; Yuanyuan Xiao, Gilead Sciences
8:35 AM

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

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 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

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

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

Thursday, 08/02/2018
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

Shewhart-Type Charts in Some Nonstandard Situations: Phase I and Phase II
Yuhui Yao, University of Alabama; Subhabrata Chakraborti, University of Alabama
11:05 AM

Adjustment for Phase II S^2 Chart Control Limits Based on Tolerance Intervals
Martin Guillermo Cornejo Sarmiento, Pontifical Catholic University of Rio de Janeiro; Subhabrata Chakraborti, University of Alabama; Eugenio Kahn Epprecht, Pontifical Catholic University of Rio de Janeiro
11:20 AM

Biomarker Guided Phase II Two-Stage Design for Targeted Therapy
Zheyu Wang, Johns Hopkins University; Fujun Wang, Medimmune; Chenguang Wang, Johns Hopkins University; Gary Rosner, Johns Hopkins University; Jianliang Zhang, Medimmune; Hao Wang, Johns Hopkins University; Li Shi, Medimmune
11:25 AM