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Keyword Search Criteria: Endpoint returned 50 record(s)
Sunday, 07/29/2018
An Innovative Approach to Identify Biomarker Signatures for Cancer Genetic Data with Survival Endpoints
Ming Wang, Pennsylvania State University; Zheng Li, Penn State Unviersity


An Innovative Approach to Identify Biomarker Signatures for Cancer Genetic Data with Survival Endpoints
Ming Wang, Pennsylvania State University; Zheng Li, Penn State Unviersity
2:50 PM

Correlation Between the Time-To-Event Endpoints in Prostate Cancer Clinical Trials
Susan Li, Janssen R&D
3:05 PM

The Win Ratio: What Is It?
Victoria Chang, AbbVie; Gaohong Dong, iStats Inc.; Junshan Qiu, US Food and Drug Administration; Marc Vandemeulebroecke, Novartis; Roland Matsouaka, Duke University School of Medicine; Di Li, Bristol-Myers Squibb Co.; David Hoaglin, University of Massachusetts Medical School
4:05 PM

Monday, 07/30/2018
Composite Endpoints for Alzheimer's Disease Clinical Trials
Steve Edland, University of California, San Diego


Dose Finding Methods Using Two Endpoints in Early Clinical Studies
Kyounghwa Bae, Janssen Research & Development, LLC; Zhentao Tong, North Carolina State University ; Vladimir Dragalin, Janssen R&D


Statistical Methods for the Analysis of Ventilator-Free Days
Charity Morgan


Impact on Statistical Power by Different Imputation Methods for Binary Endpoints with Missing Data
Xiaomei Liao, AbbVie Inc.; Jun Zhao, AbbVie; Bidan Huang, AbbVie Inc.
8:35 AM

Symptom Trials Vs Morbidity/Mortality Trials: Are Different Estimands Required?
Steven Snapinn, Amgen, Inc.
8:35 AM

Statistical Methods for the Analysis of Ventilator-Free Days
Charity Morgan
10:05 AM

Inference on Treatment Effect Modification by Marker Response in a Baseline Surrogate Measure Three-Phase Sampling Design
Michal Juraska, Fred Hutchinson Cancer Research Center; Ying Huang, Fred Hutchinson Cancer Research Center; Peter Gilbert, Fred Hutchinson Cancer Research Center
10:50 AM

A Unified Approach to the Statistical Evaluation of Differential Vaccine Efficacy
Erin Gabriel, Karolinska Institute; Dean Follmann, NIAID
11:20 AM

Dose Finding Methods Using Two Endpoints in Early Clinical Studies
Kyounghwa Bae, Janssen Research & Development, LLC; Zhentao Tong, North Carolina State University ; Vladimir Dragalin, Janssen R&D
11:55 AM

Critical Steps for Composite Endpoint Analysis
Jerry J. Li, Merck & Co., Inc.
2:20 PM

Sample Size Determination Under Non-Proportional Hazards
Zhaowei Hua, Takeda Pharmaceuticals International Co.; Miao Yang, Oregon State University; Saran Vardhanabhuti, Takeda Pharmaceuticals
2:20 PM

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

Statistical Approaches for Assessing the Utility of Urinary Glycosaminoglycans as a Surrogate Endpoint in Clinical Trials
Di Xiao, The Food and Drug Adminstration; Yeh-Fong Chen, US FDA; Min Min, U.S. Food and Drug Administration, CDER/OTS/OB
3:05 PM

Predictive Probability on Interim Analysis of Time-To-Event Endpoints with Delayed Treatment Effects
Matt Rosales, Astellas; Kentaro Takeda, Astellas Pharma Global Development, Inc.
3:35 PM

Tuesday, 07/31/2018
Defining a More Powerful Endpoint in a Longitudinal Trial with information of correlation coefficient
Ruji Yao; qing li, merck; wen-chi wu, merck


New Proposal for Equivalence Criteria in Bioequivalence Study with Binary Clinical Endpoint
Mengdie Yuan, Food and Drug Administration; Jingyu Luan, Food and Drug Administration


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


Power and Type I Error Assessments on Methods to Size Binomial Endpoints Under Unequal Randomization Ratios
Rong Wang, Pfizer Inc


Relationship Between ORR, PFS and OS in Patients Treated with Anti-PD1/PDL1 Therapies
Jiabu Ye, AstraZeneca; Pralay Mukhopadhyay, Astrazeneca; Xiang Ji, AstraZeneca


Statistical Precision of Time-to-Event Endpoint in Single Arm Observational Study Using Monte Carlo Simulation
Meijing Wu, AbbVie; Hongwei Wang, AbbVie Inc; Yabing Mai, AbbVie, Inc; Dajun Tian, Chiltern


Conditional Power Calculation for the Interim Monitoring of Cluster-Randomized Trials with Interval-Censored Endpoints
Kaitlyn Cook, Harvard University; Rui Wang, Harvard Pilgrim HealthCare Institute


Real-Time Study Milestone Projection in Clinical Trials with Time-To-Event Endpoints
Yanping Liu, Merck & Co.; Gang Jia, Merck & Co.


Statistical Approaches for Assessing the Utility of Urinary Glycosaminoglycans as a Surrogate Endpoint in Clinical Trials
Di Xiao, The Food and Drug Adminstration; Yeh-Fong Chen, US FDA; Min Min, U.S. Food and Drug Administration, CDER/OTS/OB


Conditional Power Calculation for the Interim Monitoring of Cluster-Randomized Trials with Interval-Censored Endpoints
Kaitlyn Cook, Harvard University; Rui Wang, Harvard Pilgrim HealthCare Institute
9:00 AM

Multiplicity Adjustment for Multiple Endpoints Testing in Overall and Subgroup Populations
Libo Sun, Janssen Pharmaceutical R&D; Grace Liu, Johnson & Johnson; Rui Qin, Janssen Pharmaceutical R&D
9:35 AM

Relationship Between ORR, PFS and OS in Patients Treated with Anti-PD1/PDL1 Therapies
Jiabu Ye, AstraZeneca; Pralay Mukhopadhyay, Astrazeneca; Xiang Ji, AstraZeneca
9:45 AM

Real-Time Study Milestone Projection in Clinical Trials with Time-To-Event Endpoints
Yanping Liu, Merck & Co.; Gang Jia, Merck & Co.
9:50 AM

On the Relationship Between the Causal-Inference and Meta-Analytic Paradigms for the Evaluation of Surrogate Endpoints
Geert Molenberghs, Universiteit Hasselt & Katholieke Universiteit Leuven
10:35 AM

Assessment of Biomarkers and Surrogate Endpoints in Drug Development
Ivan Chan, AbbVie Inc; Shu-Chih Su, Merck Research Labs
10:55 AM

Limitations of Progression Free Survival as a Surrogate Marker for Overall Survival in Oncology Trials
Robin Mogg, Merck Research Laboratories; Yiwei Zhang, Merck Research Laboratories
11:15 AM

Statistical Precision of Time-to-Event Endpoint in Single Arm Observational Study Using Monte Carlo Simulation
Meijing Wu, AbbVie; Hongwei Wang, AbbVie Inc; Yabing Mai, AbbVie, Inc; Dajun Tian, Chiltern
11:20 AM

Identifying and Validating Surrogate Endpoints for Overall Survial (OS) in Metastatic Castration-Resistant Prostate Cancer
Xiaowei Guan, Pfizer, Inc.; Michelle Casey, Pfizer, Inc.; De Phung, Astellas Pharma, Inc. ; Suha Sari, Pfizer, Inc.; Eren Demirhan, Pfizer, Inc.
11:35 AM

Analysis of Stratified Clinical Trials with Time-To-Event Endpoints
Devan V Mehrotra, Merck & Co., Inc.; Shanjun Helian, Merck & Co., Inc.; Shu-Chih Su, Merck Research Labs
3:05 PM

Wednesday, 08/01/2018
Incorporating Intermediate Binary Responses into Interim Analysis of a Long-Term Binary Endpoint
Andrejus Parfionovas, Takeda Pharmaceuticals; Jingjing Chen, Takeda Pharmaceuticals; Tina Liu, Takeda Pharmaceuticals; Cong Han, Takeda Pharmaceuticals; Xiaopan Yao, Takeda Pharmaceuticals


Incorporating Intermediate Binary Responses into Interim Analysis of a Long-Term Binary Endpoint
Andrejus Parfionovas, Takeda Pharmaceuticals; Jingjing Chen, Takeda Pharmaceuticals; Tina Liu, Takeda Pharmaceuticals; Cong Han, Takeda Pharmaceuticals; Xiaopan Yao, Takeda Pharmaceuticals
9:10 AM

A Model-Based Approach for Simulating Adaptive Clinical Studies with Surrogate Endpoints Used for Interim Decision-Making
Xiaotian Chen, AbbVie; Alan Hartford, AbbVie Inc; Mei Li, AbbVie; Jun Zhao, AbbVie
9:20 AM

Composite Endpoints in Clinical Trials with Multiple Correlated Dichotomous Outcomes
Boris Zaslavsky, FDA/CBER
10:05 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

A Comparison of Statistical Models for Recurrent Events with Applications to Hospitalization and Death Events
Jihong Chen, Alnylam Pharmaceuticals; Tim Lin, Alnylam Pharmaceuticals; Matthew T. White, Alnylam Pharmaceuticals; Christine Powell, Alnylam Pharmaceuticals; Andrew Strahs, Alnylam Pharmaceuticals
11:05 AM

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

Approaches to Tipping Point Analyzes for a Binary Endpoint in Longitudinal Clinical Trials
Joseph Wu, Pfizer; Huaming Tan, Pfizer, Inc.; Neal Thomas, Pfizer; Cunshan Wang, Pfizer, Inc.
2:50 PM

Handling Missing Not at Random Data for Safety Endpoint in the Multiple Dose Titration Clinical Pharmacology Trial
Li Fan, Merck; Tian Zhao, Merck; Patrick Larson, Merck
3:20 PM

Thursday, 08/02/2018
Evaluation of Treatment Effect: Beyond Traditional Subgroups
Yeh-Fong Chen, US FDA
10:55 AM

Deriving and Analyzing Endpoints from Electronic Health Record Data: a Case Study from Clinical Oncology
Sandra Griffith, Flatiron Health; Ariel Bourla, Flatiron Health; Bryan Bowser, Flatiron Health ; Geoff Calkins, Flatiron Health; Joe Chang, Flatiron Health; Rebecca Miksad , Flatiron Health ; Brian Segal, Flatiron Health; Elizabeth Sweeney, Flatiron Health ; Erin Williams, Flatiron Health ; Paul You , Flatiron Health ; Amy Abernethy, Flatiron Health
11:15 AM

Selecting Among Treatments with Two Bernoulli Endpoints
Elena M Buzaianu, University of North Florida; Pinyuen Chen, Syracuse University; Lifang Hsu, Le Moyne College
11:50 AM

Statistical Monitoring of Semi-Competing Risk Outcomes in Clinical Trials
Toshi Hamasaki; Scott Evans, Harvard University; Tomoyuki Sugimoto, Kagoshima University; Koko Asakura, National Cerebral and Cardiovascular Center; Susan Halabi, Duke University
11:50 AM