Keyword Search
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CC = Baltimore Convention Center, H = Hilton Baltimore
* = applied session ! = JSM meeting theme
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Keyword Search Criteria: clinical trials returned 90 record(s)
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Sunday, 07/30/2017
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Sources of Safety Data and Statistical Strategies for Design and Analysis in Clinical Trials
Richard C. Zink, JMP Life Sciences, SAS Institute, Inc.
2:05 PM
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Wearable Devices in Clinical Trials
Greg Hather, Takeda Pharmaceuticals; Ray Liu, Takeda Pharmaceuticals
2:05 PM
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Semiparametric Benefiting Subgroup Identification via Credible Subgroups
Patrick Schnell, University of Minnesota; Qi Tang, AbbVie, Inc.; Peter Mueller, UT Austin; Brad Carlin, University of Minnesota
2:20 PM
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An Optimized Adaptive Enrichment Design for Multi-Arm Trials
Michael Rosenblum, Johns Hopkins University; Aaron Fisher, Johns Hopkins University; Jon Steingrimsson, Johns Hopkins University; Joshua A Betz, Johns Hopkins University
2:25 PM
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Expanding the Role of N-Of-1 Trials in Regulated Clinical Trials
Samuel Dickson, USAMMDA Biostatistics Branch; Sharon A Gilbert, USAMMDA Biostatistics Branch; Cynthia V. Landefeld, USAMMDA Biostatistics Branch; Nan Guo, USAMMDA Biostatistics Branch; William F. McCarthy, USAMMDA Biostatistics Branch
3:20 PM
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Multi-Regional Clinical Trials and the ICH E17 Draft Guidance
Bruce Binkowitz, Shionogi, Inc.; Aloka Chakravarty, US FDA, CDER; Steve Snapinn, Amgen; Romi Singh, Pfizer
4:05 PM
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Adaptive Design and Statistical Consideration in Clinical Trials
Steven Sun; Grace Liu, Johnson & Johnson; Tianmeng Lyu, Univ. Minnesota Biostatistics Dept.
4:25 PM
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Marginal Meta-Analysis for Combining Multiple Randomized Clinical Trails with Rare Events
Yun-Ju UMBC Cheng, UMBC; Yi Huang, UMBC; Elande Baro, FDA; Guoxing Soon, FDA
5:35 PM
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Monday, 07/31/2017
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Sample Size Calculation in Clinical Trials with Binary Co-Primary Endpoints or Multiple Testing Procedures
Zuoshun Zhang, Celgene Corporation
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How to Treat Site in Clinical Trials - Fixed or Random?
Chul Ahn, FDA
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Two-Stage Design for Phase II Cancer Clinical Trials with Multiple Endpoints
Hui Gu, Rutgers University; Yong Lin, Rutgers; Weichung Joe Shih, Rutgers School of Public Health; Yaqun Wang, Rutgers; Kejian Liu, Celgene
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How Can Disease Progression Modeling Help Us Build Better Clinical Trials?
Melanie Quintana, Berry Consultants
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Analysis of Adverse Event Relationships in Clinical Trials Using JMP
Anastasia Dmitrienko; Kelci Miclaus, JMP Life Sciences, SAS Institute Inc.; Richard C. Zink, JMP Life Sciences, SAS Institute, Inc.
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Emax Modeling for Assessing Dose-Response Relationships Using JMP
Beibo Zhao, University of North Carolina at Chapel Hill; Richard C. Zink, JMP Life Sciences, SAS Institute, Inc.
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Methodologies for Clinical Trials Using Historical Control
Yeh-Fong Chen, US Food and Drug Administration
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Phase II Trials and the Use of Registry Controls
Ruta Brazauskas, Institute for Health & Society-Medical College of Wisconsin; Brent Logan, Institute for Health & Society-Medical College of Wisconsin; Raphael Fraser, Institute for Health & Society-Medical College of Wisconsin
8:50 AM
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Simulation-Based Evaluation of P-Value Quality in Phase 3 Clinical Trials
Jihao Zhou, Allergan, Inc.; Ray Zhu, Allergan, Inc.; Brandon Wales, University of California at Riverside; Thomas Lin, University of California at Irvine
9:05 AM
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Estimating Causal Effects from a Randomized Clinical Trial When Noncompliance Is Measured with Error
Jeffrey Boatman; David Vock, University of Minnesota; Joseph Koopmeiners, University of Minnesota; Eric Donny, University of Pittsburgh
9:35 AM
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Flexible Hypothesis Testing Method for Clinical Trials Using Composite Endpoint
Jin Xu, Merck; David Li, Pfizer
9:35 AM
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Issues Related to Statistical Validation of Minimal Residual Disease as a Surrogate Endpoint for Clinical Trials and Drug Approvals in AML
Liang Xiu, Janssen Research and Development; Rianka Bhattacharya, Janssen Research and Development; Jianan Hui, University of California, Riverside; Hong Tian, Janssen Research and Development
9:50 AM
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A Site-Adjusted Approach to the Covariate-Adjusted Response-Adaptive Allocation Design in Multi-Center Trials
Brian Di Pace, Virginia Commonwealth Univ; Roy T Sabo, Virginia Commonwealth University
10:50 AM
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Methodologies for Clinical Trials Using Historical Control
Yeh-Fong Chen, US Food and Drug Administration
10:55 AM
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On Effect Sizes for Nonparametric Comparison of Censored Survival Outcomes
Yongzhao Shao, New York University-School of Medicine; Zhaoyin Zhu, NYU
11:50 AM
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The Role of Intermediate Observations When Outcome Data Are Missing in Longitudinal Randomized Clinical Trials
Joseph Rausch, Nationwide Children's Hospital
2:05 PM
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A Simple and Flexible Graphical Approach for Adaptive Group-Sequential Clinical Trials
Frank Bretz, Novartis AG; Toshifumi Sugitani, Astellas; Willi Maurer, Novartis
2:05 PM
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Shedding a Bayesian Light on the Evidence-Based Medicine
J. Jack Lee, UT MD Anderson Cancer Ctr.
2:35 PM
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Designing Multi-Stage Clinical Trials with Multiple Event-Time Endpoints
Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center; Scott Evans, Harvard University ; Tomoyuki Sugimoto, Kagoshima University; Koko Asakura, National Cerebral and Cardiovascular Center
2:45 PM
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A Powerful Learn-And-Confirm Pharmacogenomics Methodology for Randomized Clinical Trials
Devan Mehrotra, Merck & Co. Inc. ; Qian Guan, North Carolina State University; Zifang Guo, Merck & Co., Inc.
2:45 PM
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Re-Analyzing Clinical Trials Through the Bayesian Lens
Margaret Gamalo-Siebers, Eli Lilly; Karen Price, Eli Lilly; Stephen J Ruberg, Eli Lilly and Co
2:50 PM
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Efficient Approaches to Identifying Markers That Predict Treatment Effects in Randomized Clinical Trials
James Dai, Fred Hutchinson Cancer Research Center; Michael LeBlanc, Fred Hutchinson Cancer Research Center
3:05 PM
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Tuesday, 08/01/2017
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Increasing and Balancing the Power of Multiple Tests in Optimal Treatment Duration Clinical Trials
Yongdong Ouyang, University of Birtish Columbia; Hubert Wong, University of British Columbia
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Personalized Endpoints
Marian Strazzeri, US Food and Drug Administration
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Wearable Devices in Daily Activities and Clinical Trials
R. Lakshmi Vishnuvajjala, FDA/CDRH
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Outcomes Following Concomitant Traumatic Brain Injury and Hemorrhagic Shock: a Secondary Analysis of the PROPPR Trial
Savitri N. Appana, The University of Texas Health Science Center at Houston; Erin E Fox, The University of Texas Health Science Center, Center for Translational Injury Research; Sarah Baraniuk, The University of Texas Health Science Center at Houston; Patrick L Bosarge, University of Alabama School of Medicine; Elieen M. Bulger, University of Washington Department of Surgery; Rachael A. Callcut, University of California San Francisco Division of General Surgery; Bryan A. Cotton, The University of Texas Health Science Center at Houston; Michael Goodman, University of Cincinnati School of Medicine; Kenji Inaba, University of Southern California Keck School of Medicine; Terence O'Keeffe, University of Arizona School of Medicine; Martin A. Schreiber, Oregon Health & Science University School of Medicine; Charles E. Wade, The University of Texas Health Science Center, Center for Translational Injury Research; Thomas M. Scalea, University of Maryland School of Medicine; John B. Holcomb, The University of Texas Health Science Center at Houston; Deborah M. Stein, University of Maryland School of Medicine; Samuel M. Galvagno Jr., University of Maryland School of Medicine
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Maintaining Trial Integrity for Randomized Open-Label Trials
Wenyun Ji, Amgen, Inc.
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On the Estimation of Risk Difference in the Presence of Continuous Baseline Covariates
Hua Ma, Merck; Robin Mogg, Merck
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Adaptive Bayesian Modeling and Prediction of Patient Accrual with Varying Activation Time in Multicenter Clinical Trials
Junhao Liu, University of Kansas Medical Center; Yu Jiang, School of Public Health, University of Memphis; Jo Wick, University of Kansas Medical Center; Byron Gajewski, Department of Biostatistics, University of Kansas Medical Center
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A Principal Stratification Approach to Evaluate the Causal Effect of A Patient Activation Intervention For Bone Health Outcomes
YIYUE LOU, University of Iowa; Michael P. Jones, University of Iowa; Stephanie W. Edmonds, University of Iowa; Fredric D. Wolinsky , University of Iowa; Peter Cram, University of Iowa
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Numerical Evaluation of the Efficiency of a Binary Versus Time-To-Event Endpoint
Zhibao Mi, VA CSPCC Perry Point; Eileen Stock, VA CSPCC Perry Point; Kousick Biswas, VA Cooperative Studies Program Coordinating Center; Joseph F Collins, VA Cooperative Studies Program Coordinating Center
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Missing Data Imputation Strategies for Different Estimands in Clinical Trials
Ye Tan, Pfizer; Steven Gilbert, Pfizer Inc.
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Social Media and Clinical Trials
Darcy Hille, Merck; T. Ceesay, Merck & Co, Inc.
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Tradeoffs of a Randomize, Then Consent Approach to Improving Cluster Participation Rates in Cluster Randomize Trials
Abigail Shoben, The Ohio State University
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Tradeoffs of a Randomize, Then Consent Approach to Improving Cluster Participation Rates in Cluster Randomize Trials
Abigail Shoben, The Ohio State University
8:35 AM
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A Principal Stratification Approach to Evaluate the Causal Effect of A Patient Activation Intervention For Bone Health Outcomes
YIYUE LOU, University of Iowa; Michael P. Jones, University of Iowa; Stephanie W. Edmonds, University of Iowa; Fredric D. Wolinsky , University of Iowa; Peter Cram, University of Iowa
8:55 AM
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Maintaining Trial Integrity for Randomized Open-Label Trials
Wenyun Ji, Amgen, Inc.
9:05 AM
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Numerical Evaluation of the Efficiency of a Binary Versus Time-To-Event Endpoint
Zhibao Mi, VA CSPCC Perry Point; Eileen Stock, VA CSPCC Perry Point; Kousick Biswas, VA Cooperative Studies Program Coordinating Center; Joseph F Collins, VA Cooperative Studies Program Coordinating Center
9:05 AM
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On the Estimation of Risk Difference in the Presence of Continuous Baseline Covariates
Hua Ma, Merck; Robin Mogg, Merck
9:20 AM
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Adaptive Designs in Phase II Basket Clinical Trials
Kristen Cunanan; Alexia Iasonos, Memorial Sloan Kettering Sloan Cancer Center; Ronglai Shen, Memorial Sloan Kettering Cancer Center; Colin Begg, Memorial Sloan Kettering Cancer Center; Mithat Gonen, Memorial Sloan Kettering Cancer Center
9:35 AM
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The New ICH Guideline on Estimands: An Academic Perspective
Eric Tchetgen Tchetgen, Harvard University ; Estelle Russek-Cohen, U.S. Food and Drug Administration; Scott Emerson, University of Washington ; Susan Ellenberg, University of Pennsylvania ; T. Shun Sato, University of Kyoto
10:35 AM
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Decision of Performing Interim Analysis for Comparative Clinical Trials
Kyongsun Pak, Kitasato University; Susanna Jacobus, Dana Farber Cancer Institute; Hajime Uno, Dana Farber Cancer Institute
10:35 AM
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Missing Data Imputation Strategies for Different Estimands in Clinical Trials
Ye Tan, Pfizer; Steven Gilbert, Pfizer Inc.
10:35 AM
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Adaptive Bayesian Modeling and Prediction of Patient Accrual with Varying Activation Time in Multicenter Clinical Trials
Junhao Liu, University of Kansas Medical Center; Yu Jiang, School of Public Health, University of Memphis; Jo Wick, University of Kansas Medical Center; Byron Gajewski, Department of Biostatistics, University of Kansas Medical Center
10:40 AM
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The Three Keys to Having Effective Interim Review Data Monitoring Committee Meetings for Clinical Trials
Navneet Hakhu, Axio Research
10:50 AM
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Social Media and Clinical Trials
Darcy Hille, Merck; T. Ceesay, Merck & Co, Inc.
10:55 AM
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Patient-Reporting of Symptomatic Toxicities of Cancer Treatment: Current Progress and Emerging Challenges
Sandra Anne Mitchell, National Cancer Institute
2:05 PM
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PRO-CTCAE Implementation in Oncology Clinical Trials: An Industry Perspective
Paivi Miskala, Pfizer Inc
2:25 PM
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Sensitivity Analysis for Longitudinal Clinical Trials with Nonmonotone Missingness
Antonio R Linero, Florida State University
2:45 PM
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PRO-CTCAE in Oncology Clinical Trials: a U.S. Regulatory Perspective
Paul Kluetz, U.S. Food and Drug Administration
2:45 PM
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Statistical Methods to Analyze PRO-CTCAE Data in Oncology Clinical Trials
Amylou Dueck, Mayo Clinic
3:05 PM
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Dealing with Competing Risks in Clinical Trials: What Are the Proper Questions to Ask and How Best to Answer Them?
James Troendle, National Institutes of Health; Eric Leifer, NIH; Lauren Kunz, NIH
3:20 PM
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Wednesday, 08/02/2017
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Clinical Trials Start up Process
Yi Zhong; Dinesh Mudaranthakam, Department of Biostatistics, University of Kansas Medical Center; Byron Gajewski, Department of Biostatistics, University of Kansas Medical Center; Kevin Smilor, 2. Division of Clinical Research Administration, University of Kansas Medical Center; Karen Blackwell, Human Research Protection Program, University of Kansas Medical Center
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Beyond the Statistical Analysis Plan: Statisticians Partaking Earlier in Design of Clinical Trials
Yuqun Abigail Luo, FDA
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Estimating Causal Effects from Using Augmented Inverse Probability Weighted Estimators When Noncompliance Is Measured with Error
David Vock, University of Minnesota; Jeffrey Boatman; Joseph Koopmeiners, University of Minnesota
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BOP2: Bayesian Optimal Designs for Phase II Clinical Trials with Simple and Complex Endpoints
Heng Zhou, MD Anderson Cancer Center; Ying Yuan, M.D. Anderson Cancer Center
8:35 AM
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Essential Statistical Methods for Molecular Diagnostics
Jesse Albert Canchola, Roche Molecular Systems Inc.; Pari Hemyari, Roche Molecular Systems Inc.
8:50 AM
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BAYESIAN PROBABILITY of SUCCESS for MULTIPLE CLINICAL TRIALS in CONTINUOUS OUTCOMES
Junnosuke Matsushima, Chugai Pharma USA
8:50 AM
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Improving Subgroup Identification: Type I Error Control, Power, and the Quality of Subgroups
Lei Shen, Eli Lilly and Company
8:55 AM
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Estimating Causal Effects from Using Augmented Inverse Probability Weighted Estimators When Noncompliance Is Measured with Error
David Vock, University of Minnesota; Jeffrey Boatman; Joseph Koopmeiners, University of Minnesota
8:55 AM
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Estimand Choice and Handling of Treatment Switch in Randomized Clinical Trials
Ulker Aydemir, INC Research
9:05 AM
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Stochastic Optimization of Adaptive Enrichment Designs for Two Subpopulations
Michael Rosenblum, Johns Hopkins University; Aaron Fisher, Harvard University-Department of Biostatistics; Joshua A Betz, Johns Hopkins University; Jon Steingrimsson, Johns Hopkins University
9:35 AM
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Estimand in Evaluating Predictive or Selection Markers Using Enrichment Design in Clinical Trials
Jingjing Ye, FDA
9:55 AM
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Effective Use of Multiple Primary Endpoints and Composite Endpoints in Assessing Collective Evidence in Clinical Trials
George Kordzakhia, FDA; Yeh-Fong Chen, US Food and Drug Administration
11:05 AM
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Missing Data - How Much Is Too Much ?
Lilianne (Lee-Lian) Kim, Janssen Pharmaceuticals R&D; Kim Hung Lo, Janssen R&D, LLC
11:20 AM
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Model-based Design for the Early Development of Cancer Immunotherapy Combinations
Nolan Wages, University of Virgina
11:35 AM
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Design and Analysis of Single Arm Clinical Trials Involving Highly Heterogeneous Subjects
Sherry Liu, FDA
11:55 AM
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Implementing Multiple Imputation in Non-Inferiority Clinical Trials
Brian Wiens, Tobira Therapeutics; Ilya Lipkovich, QuintilesIMS
12:05 PM
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Interplay Between Estimands and Missing Data in Clinical Trials
David Ohlssen, Novartis
2:05 PM
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Thursday, 08/03/2017
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Overview of Estimands, Estimators, and Sensitivity for Longitudinal Clinical Trials
Craig Mallinckrodt, Eli Lilly & Co.
8:35 AM
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Prospective Specification of a Conditional Power Prior for Clinical Trials
Tyson Rogers, NAMSA
9:05 AM
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Multiple Testing Approaches in Device Clinical Trials
Vandana Mukhi, FDA/CDRH; Heng Li, U. S. FDA
9:20 AM
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Benefit Risk Assessment in Medical Device Clinical Trials
Mourad Atlas, FDA; Chul Ahn, FDA
9:50 AM
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Continual Reassessment Method for Partially Ordered Groups
Bethany Horton, The University of Virginia; Nolan Wages, The University of Virginia; Mark Conaway, The University of Virginia
10:05 AM
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Predicting Subject Enrollment in Clinical Trials
Matthew Austin, Amgen, Inc.
10:35 AM
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A Robust Paradigm of Finding the Maximum Tolerated Dose in Phase I Cancer Clinical Trials
Tina Young, Bristol-Myers Squibb; Dirk Moore, Rutgers School of Public Health; Yong Lin, Rutgers; Weichung Joe Shih, Rutgers School of Public Health
10:50 AM
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Evaluating Imaging Inclusion Criteria for Stroke Clinical Trials: Appropriate Enrichment Versus Cherry Picking
Robyn L Ball, Stanford University; Bin Jiang, Stanford University; Manisha Desai, Stanford University; Max Wintermark, Stanford University
10:50 AM
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Literature Review Providing a Summary of Adaptive Design Usage in Pharmaceutical Clinical Development
Xiaotian Chen
11:15 AM
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Multi-Arm Bayesian Designs for Clinical Trials
Lorenzo Trippa, Dana-Farber Cancer Institute, Harvard
11:25 AM
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On the Use of Empirical Bayes Techniques to Bridge from an in Vitro System to a Clinical Trial
Ya Meng, Sanofi Pasteur; Camille Salamand, Sanofi Pasteur; Robert D. Small, Sanofi Pasteur
11:35 AM
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Constructing a Synthetic Control Arm from Previous Clinical Trials, with Application to Cancer Trials
Steven Schwager, Medidata Solutions; Michael Elashoff, Medidata Solutions; Philip Beineke, Medidata Solutions; Ruthanna Davi, Medidata Solutions
11:50 AM
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Select a Better Treatment Using Efficacy Safety and Patients' Preference
Kao-Tai Tsai
12:05 PM
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