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Keyword Search Criteria: Clinical Trials returned 29 record(s)
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Monday, 07/30/2018
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Machine-Learning Approach to Defining Covariates to Increase Study Power in ALS Clinical Trials and Other Multifactorial Heterogeneous Disease Areas
Danielle Beaulieu, Origent Data Sciences; Albert Taylor, Origent Data Sciences; Samad Jahandideh, Origent Data Sciences; David Ennist, Origent Data Sciences; Andrew Conklin, Origent Data Sciences; Mike Keymer, Origent Data Sciences
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Improving the Design of Pragmatic Clinical Trials Using Data Collected from Electronic Medical Records
Susan Shortreed, Kaiser Permanente Washington Health Research Institute; Carlyn M Rutter, RAND Corporation; Andrea J. Cook, Kaiser Permanente Washington Health Research Institute; Greg Simon, Kaiser Permenete Washington Health Research Insitute
9:15 AM
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Leveraging Omics Biomarker in Early Clinical Trials - Concept, Utility and Impact on Decision Making
Weidong Zhang, Pfizer Inc.
10:35 AM
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Use of Piecewise Weighted Log-Rank Test for Trials with Delayed Treatment Effect
Boguang Zhen, FDA; Zhenzhen Xu , FDA; Bin Zhu, NIH/NCI; Yongsoek Park, Unversity of Pittsburgh
11:25 AM
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A Parametric Multiple Comparison Procedure for Clinical Trials with Planned Evaluation of Treatment Effect in Pre-Defined Subgroups and Interim Analyzes
Liang Fang, MyoKardia; Ron Yu, Gilead Sciences, Inc.; Zhishen Ye, Gilead Sciences; Neby Bekele, Gilead Sciences; Ming Lin, Gilead Sciences
3:05 PM
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Bayesian Isotonic Optimal Dose Design for Phase I/II Clinical Trials with Ordered Groups
Xiaoqiang Xue
3:05 PM
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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
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Tuesday, 07/31/2018
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Assessing Reproducibility When Making Mid-Course Changes in Clinical Trials Based on External Data
Yingqi Shi, Johnson & Johnson-Janssen R&D; Grace Gao, Janssen R&D; Keith Karcher, Janssen R&D
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Adaptively Incorporating Supplemental Information in Clinical Trials in the Presence of Population Heterogeneity
Joseph Koopmeiners, Division of Biostatistics, University of Minnesota; Ales Kotalik, University of Minnesota; David Michael Vock, University of Minnesota
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Multiple Testing Procedure Consideration in Clinical Trials
Rachael Wen, Sanofi
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Real-Time Study Milestone Projection in Clinical Trials with Time-To-Event Endpoints
Yanping Liu, Merck & Co.; Gang Jia, Merck & Co.
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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
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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
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Real-Time Study Milestone Projection in Clinical Trials with Time-To-Event Endpoints
Yanping Liu, Merck & Co.; Gang Jia, Merck & Co.
9:50 AM
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Safety Analysis of Clinical Trials in NDA Submissions
Linyun Zhou, Takeda Global Research & Development
10:05 AM
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Multiple Testing Procedure Consideration in Clinical Trials
Rachael Wen, Sanofi
11:30 AM
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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
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Integrating Data from Clinical Trials for More Powerful Mediation and Interaction Analyzes
Linda Valeri, McLean Hospital, Harvard Medical School; Yiwen Zhu, Massachussetts General Hospital; Franca Centorrino, McLean Hospital; Garrett Fitzmaurice, McLean Hospital
11:55 AM
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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
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A Bayesian Hierarchical Model Estimating CACE in Meta-Analysis of Randomized Clinical Trials with Noncompliance
Jincheng Zhou, University of Minnesota; Haitao Chu, University of Minnesota Twin Cities; James S. Hodges, University of Minnesota; M. Fareed Khan Suri, University of Minnesota
3:25 PM
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Thursday, 08/02/2018
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Dynamic Treatment Regimens for Superbug Infections
Dean Follmann, NIAID
8:35 AM
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Inference for Clinical Trials That Rely on Historical Data: a Review of Statistical Approaches for Reducing Risk of Bias
Lei Nie, Division of Biometrics V, office of Biostatistics, CDER/FDA; James Signorovitch, Analysis Group; Rajeev Ayyagari, Analysis Group
8:55 AM
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An Overview of Matching Adjusted Indirect Comparisons in Single Arm Clinical Trials with Practical Recommendations and Potential Challenges
Dawn Odom, RTI Health Solutions; Molly Purser, RTI Health Solutions; Lawrence Rasouliyan, RTI Health Solutions
9:15 AM
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Marginal Meta-Analysis for Combining Multiple Randomized Clinical Trials with Rare Events
Yi Huang, University of Maryland, Baltimore County; Elande Baro, US FDA; Yun-Ju Cheng, University of Maryland, Baltimore County; Guoxing Song, US FDA
11:35 AM
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