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: ALS returned 223 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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Data-Driven Confidence Interval Estimation Incorporating Prior Information with an Adjustment for Skewed Data
Li Zou, State University of New York At Buffalo; Albert Vexler, State University of New York at Buffalo; Alan Hutson, Roswell Park Cancer Institute
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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Randomziation and Permutation Tests of Network Structure
Mark M. Fredrickson, University of Illinois at Urbana-Champaign
2:05 PM
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Towards Accounting for Model Error in CO2 Retrievals from the OCO-2 Satellite
Jenny Brynjarsdottir, Case Western Reserve University; Jonathan Hobbs, Jet Propulsion Laboratory; Amy Braverman, Jet Propulsion Laboratory
2:05 PM
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Techniques for Matched Randomization in Sequential Enrollment Trials
Jonathan J Chipman, Vanderbilt University; Cole Beck, Vanderbilt University; Robert A Greevy, Jr, Vanderbilt University
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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P-Values: Variability, Reproducibility and Lessons from Multiple Testing
Naomi Altman, Penn State University
2:30 PM
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Determining Personalized Dosing Intervals
Xiaomao Li, university of wisconsin-madison; Jun Shao, university of wisconsin-madison; Menggang Yu, university of wisconsin-madison
2:35 PM
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A General Algorithm for Computing Simultaneous Prediction Intervals for the (Log)-Location-Scale Family of Distributions
William Meeker, Iowa State University; Yimeng Xie, Virginia Tech; Yili Hong, Virginia Tech; Luis A Escobar, Louisiana State University
2:35 PM
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Bayesian Methods for Analysis of Biosimilar Phase III Trials
Robert Weiss, UCLA Fielding School of Public Health; Xiaomao Simon Xia, University of Missouri; Nan Zhang, Amgen Inc; Hui Wang, Amgen Inc; Eric Chi, Amgen, Inc.
2:35 PM
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Investigating Multiple Imputation in Cluster Randomized Trials
Brittney Bailey, The Ohio State University; Rebecca Andridge, Ohio State University; Abigail Shoben, The Ohio State University
2:35 PM
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Computation of Ancestry Scores with Mixed Families and Unrelated Individuals
Fred Wright, North Carolina State University; Yi-Hui Zhou, North Carolina State University; J. S. (Steve) Marron, University of North Carolina
2:50 PM
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Identifying Differentially Expressed Genes from Two Transcriptomes of an Individual -- a Step Toward Precision Medicine
Qike Li, University of Arizona; Helen Zhang, University of Arizona; Yves Lussier, University of Arizona
3:05 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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Hypothesis Testing of Matrix Graph Model
Yin Xia, Fudan University
4:05 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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Finding needles in a haystack? Covariate Information for Feature Screening in Ultrahigh-Dimensional Data
Debmalya Nandy, Penn State University; Francesca Chiaromonte, Penn State University; Runze Li, The Pennsylvania State University
4:50 PM
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Selective Inference in Genomics
Chiara Sabatti, Stanford University
4:55 PM
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Methods to Detect and Eliminate Outliers in Longitudinal Childhood Obesity Data
Mallik Rettiganti, University of Arkansas for Medical Sciences; Avishek Chakraborty, University of Arkansas; Anthony Goudie, University of Arkansas for Medical Sciences
5:05 PM
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Exploring Effect Heterogeneity in Multi-Centre Trials with First-Party Measurements of Mediators and Confounders
David Judkins, Abt Associates, Inc.
5:20 PM
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Bayesian Regression Using an Approximated Solution to the Penalized Least Squares Minimization Problem
Eduardo Trujillo Rivera
5:25 PM
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Assessing Residual Diagnostics for Ordinal Response Models
Altea Lorenzo-Arribas, University of Southampton / Biomathematics and Statistics Scotland; Antony M Overstall, University of Southampton; Mark J Brewer, Biomathematics and Statistics Scotland
5:35 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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Data Science Tutorials
Shonda Kuiper, Grinnell College; Laura Chihara, Carleton College; Adam Loy, Lawrence University
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A Bayesian Adaptive Design in Cancer Phase I Trials Using Dose Combinations with Ordinal Toxicity Grades
Sungjin Kim, Cedars-Sinai Medical Center; Marcio Diniz, Cedars Sinai Medical Center; Mourad Tighiouart, Cedars-Sinai Medical Center
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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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Drug Combination Dose Allocation Using Minimal Sets and Coherence in Partially Ordered Sets in Phase I Cancer Trials
Galen Cook-Wiens, Cedars Sinai Medical Center; Matthieu Clertant, Cedars-Sinai Medical Center; Mourad Tighiouart, Cedars-Sinai Medical Center
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How Can Disease Progression Modeling Help Us Build Better Clinical Trials?
Melanie Quintana, Berry Consultants
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Non-Inferiority Trials for Efficacy and Safety
Steve Snapinn, Amgen
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Using an Onset-Anchored Bayesian Hierarchical Model to Improve Predictions for Amyotrophic Lateral Sclerosis Disease Progression
Alex Karanevich
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What Is the Best Design for Dose-Finding Trials with Small Number of Doses?
Lai Wei; Julie Stephens, The Ohio State Univeristy; Vedat Yildiz, The Ohio State University; Marilly Palettas, The Ohio State University; Songzhu Zhao, The Ohio State University; Xueliang Pan, The Ohio State Univeristy
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Analysis Timing in Oncology Immunotherapy Trials with a Late Separation of Overall Survival Curve
Shu-Chih Su, Merck
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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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SYSTEMATIC REVIEW of MISSING DATA HANDLING in NON-INFERIORITY TRIALS
Brooke Rabe, University of Arizona; Mallorie Fiero, U.S. Food and Drug Administration; Melanie Bell, University of Arizona
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The Evaluation of Integrals of the Form [f(s,t)*Bivariate Normal(s,t)]. Application to Correlated Bivariate Logistic-Gaussian Models
Edmund Ameyaw, Howard University; Paul Bezandry, Howard University; Victor Apprey, Howard University; John Kwagyan, Howard University College of Medicine, General Clinical Research Center
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Design of Drug Combination Early Phase Cancer Trials Using Time to Toxicity Data
Marcio Diniz, Cedars Sinai Medical Center; José Jimenez, Politecnico di Torino; Andre Rogatko, Cedars Sinai Medical Center; Mourad Tiguiouart, Cedars Sinai Medical Center
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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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Relative Efficiency of Unequal Versus Equal Cluster Sizes in Cluster Randomized Trials Using Generalized Estimating Equation Models
Esther Lu, Washington University School of Medicine
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Using Interrupted Time Series to Examine the Validity of the Surveillance Definition of Catheter-Associated Urinary Tract Infection in U.S. Hospitals
Minn Soe, Surveillance Branch, DHQP, NCEZID, CDC
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Methodologies for Clinical Trials Using Historical Control
Yeh-Fong Chen, US Food and Drug Administration
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Increasing Precision and Removing Conditional Bias by Appropriate Adjustment for Baseline Variables in Randomized Trials
Bingkai Wang, Johns Hopkins Bloomberg SPH; Michael Rosenblum, Johns Hopkins University
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Improving Power in Group Sequential, Randomized Trials by Adjusting for Prognostic Baseline Variables and Short-Term Outcomes
Tianchen Qian, Johns Hopkins University; Michael Rosenblum, Johns Hopkins University; Huitong Qiu, Vatic Lab
8:35 AM
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Uncertainty Quantification for Network Regression
Frank W Marrs, Colorado State University; Bailey Fosdick, Colorado State University; Tyler McCormick, University of Washington
8:35 AM
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A Regression Framework for the Proportion of True Null Hypotheses
Simina Boca, Georgetown University Medical Center; Jeffrey Leek, Johns Hopkins Bloomberg School of Public Health
8:35 AM
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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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Covariate-Powered Weighted Multiple Testing with False Discovery Rate Control
Huber Wolfgang, EMBL; Nikos Ignatiadis, Stanford University
8:55 AM
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Surrogacy for Regulatory Approval: The Follicular Lymphoma Analysis of Surrogate Hypothesis (FLASH) Project
Qian Shi, Mayo Clinic
9:00 AM
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Combining Biomarkers by Maximizing the True Positive Rate for a Fixed False Positive Rate
Allison Meisner, University of Washington; Marco Carone, University of Washington Department of Biostatistics; Margaret Pepe, Fred Hutchinson Cancer Research Center; Katie Kerr, University of Washington Department of Biostatistics
9:05 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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Estimation of Causal Effects in Randomized Trials of Infectious Disease Prevention with General Interference
Nicole Bohme Carnegie, University of Wisconsin-Milwaukee
9:35 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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Patient-Reported Outcomes: Observations of Regulatory Approvals by the Center for Biologics Evaluation and Research
Hussein Ezzeldin, FDA/CBER; Megan Moncur, FDA/CBER; Yuqun Abigail Luo, FDA/CBER; Telba Irony, Office of Biostatistics and Epidemiology, CBER, FDA
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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Bayesian Nonparametric Policy Search with Application to Periodontal Recall Intervals
Qian Guan, North Carolina State University; Brian Reich, NCSU; Eric Laber, North Carolina State University; Dipankar Bandyopadhyay, Virginia Commonwealth University
9:55 AM
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Relative Efficiency of Unequal Versus Equal Cluster Sizes in Cluster Randomized Trials Using Generalized Estimating Equation Models
Esther Lu, Washington University School of Medicine
10:35 AM
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Using Interrupted Time Series to Examine the Validity of the Surveillance Definition of Catheter-Associated Urinary Tract Infection in U.S. Hospitals
Minn Soe, Surveillance Branch, DHQP, NCEZID, CDC
10:35 AM
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Empirical Likelihood Confidence Intervals for Mean Medical Cost
Gengsheng Qin, Georgia State University; Jenny Jeyarajah, Georgia State University
10:35 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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Estimators and Confidence Intervals for Adaptive Two-Stage Designs for Population Enrichment
Vladimir Dragalin, Janssen R&D; Ionut Bebu, The George Washington University
10:55 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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Signal Detection from Large Drug Safety Databases
Ram Tiwari, FDA/CDER/OT/OB
11:05 AM
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Using Bayesian Methods to Incorporate Historical Information on Control Rate and Treatment Effect: An HIV-Paediatric Trial
Clara Dominguez Islas, MRC Biostatistics Unit; Nicky Best, GlaxoSmithKline; Rebecca Turner, MRC Biostatistics Unit; Naomi Givens, GlaxoSmithKline; Rimgaile Urbaityte, GlaxoSmithKline; Sophie Barthel, GlaxoSmithKline; Adrian Mander, MRC Biostatistics Unit
11:35 AM
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Increasing Precision and Removing Conditional Bias by Appropriate Adjustment for Baseline Variables in Randomized Trials
Bingkai Wang, Johns Hopkins Bloomberg SPH; Michael Rosenblum, Johns Hopkins University
11:40 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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Structure Adaptive Multiple Testing
Ang Li, University of Chicago; Rina Foygel Barber, University of Chicago
2:05 PM
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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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A Latent Variable Approach to Elicit Continuous Toxicity Scores and Severity Weights for Multiple Toxicities in Dose-Finding Oncology Trials
Nathaniel O'Connell, Medical University of South Carolina; Elizabeth Garrett-Mayer, Medical University of South Carolina
2:05 PM
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Personalizing Early Detection for Ovarian Cancer with Hierarchical Longitudinal Models of a Blood Biomarker: Experience in Multiple Prospective Screening Trials
Steven Skates, MGH/Biostatistics Center
2:25 PM
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AdaPT: An Interactive Procedure for Multiple Testing with Side Information
William Fithian, UC Berkeley Statistics; Lihua Lei, UC Berkeley Statistics
2:30 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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Private False Discovery Rate Control
Weijie Su, University of Pennsylvania; Cynthia Dwork, Harvard University; Li Zhang, Google Inc.
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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Adaptive Multigroup Confidence Intervals with Constant Coverage
Chaoyu Yu, University of Washington; Peter Hoff, Duke University
3:05 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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Confirmatory Group Sequential Adaptive Designs for Time-To-Event Endpoints Using a Short-Term Endpoint for Treatment Arm or Population Selection
Gernot Wassmer, Medical University of Vienna, Austria; Martin Posch, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University o; Franz Koenig, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University o; Silke Joergens, ICON Clinical Research Inc, Cologne Germany
3:05 PM
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Tuesday, 08/01/2017
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Dose Finding in Oncology Trials: a Discussion on Challenges and Current Methods
Zhao Yang, Amgen, Inc.
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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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Size Investing Strategy on Multiple Confidence Intervals Under FWER
Taeho Kim; Edsel Aldea Pena, University of South Carolina
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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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Random Effects Models for Meta-Analysis of Causal Effects in Randomized Trials with Noncompliance
Jincheng Zhou, University of Minnesota; Haitao Chu, University of Minnesota
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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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Accounting for Baseline Covariates and Missing Data in Regulatory Trials with Longitudinal Designs
Elizabeth Colantuoni, Johns Hopkins University; Jon Steingrimsson, Johns Hopkins University; Aidan McDermott, Johns Hopkins University; Michael Rosenblum, Johns Hopkins 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
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Nonparametric Prediction and the Exoplanet Mass-Radius Relationship
Bo Ning, North Carolina 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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Accounting for Baseline Covariates and Missing Data in Regulatory Trials with Longitudinal Designs
Elizabeth Colantuoni, Johns Hopkins University; Jon Steingrimsson, Johns Hopkins University; Aidan McDermott, Johns Hopkins University; Michael Rosenblum, Johns Hopkins University
8:45 AM
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A Two-Stage Design for Phase III Trials with Population Selection
Wen Li, Merck & Co. Inc.
8:50 AM
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Random Effects Models for Meta-Analysis of Causal Effects in Randomized Trials with Noncompliance
Jincheng Zhou, University of Minnesota; Haitao Chu, University of Minnesota
8:50 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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A Practical Bayesian Adaptive Design with Application to Cardiovascular Outcomes Trials
Matthew Psioda, UNC Chapel Hill; Joseph G Ibrahim, UNC; Mat Soukup, Center for Drug Evaluation and Research, Office of Translational Sciences, FDA
9:05 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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Flexible parametric approach to classical measurement error variance estimation without auxiliary data
Ingrid Van Keilegom, ORSTAT, KU LEUVEN
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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A Permutation-Based Non-Parametric Analysis of CRISPR Screen Data
Gaoxiang Jia, Southern Methodist University & UT Southwestern Medical Center; Xinlei Wang, Southern Methodist University; Guanghua Xiao, UT Southwestern Medical Center
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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The Use of Small N Sequential Multiple Assignment Randomized Trials (SnSMART) in Rare Disease Research
Roy N Tamura, University of South Florida ; Kelley M Kidwell, University of Michigan; Boxian Wei, University of Michigan ; Thomas Braun, University of Michigan
11:00 AM
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Confidence Intervals for Heritability via Haseman-Elston Regression
Tamar Sofer, University of Washington, Department of Biostatistics
11:15 AM
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A Review of the Sample Size Calculations of Randomised Controlled Trials Funded by One of the Leading Funders in the UK
Steven Julious, University of Sheffield; Jo Rothwell, University of Sheffield
11:15 AM
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On Testing Goodness-of-Fit of AR(P) Model Through the Serial Dependence of the Residual Process
Phyllis Wan, Columbia University; Richard A. Davis, Columbia University; Muneya Matsui, Nanzan University; Thomas Mikosch, University of Copenhagen
11:20 AM
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Robust Inference for Group Sequential Trials
Jitendra Ganju; Yunzhi Lin, AbbVie; Kefei Zhou, Theravance
11:20 AM
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Assessment of RNA-Seq Differential Expression Methods Based on TCGA Data
Guy Brock, Center for Biostatistics, The Ohio State University College of Medicine; Meredith McCormack-Mager, Center for Biostatistics, The Ohio State University College of Medicine; Yu Lianbo, Center for Biostatistics, The Ohio State University College of Medicine; Soledad Fernandez , Center for Biostatistics, The Ohio State University College of Medicine
11:35 AM
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Calibration for Domain Totals for Business Surveys
Geoffrey Logan, Statistics Canada; Leon Jang, Statistics Canada; Michael A. Hidiroglou, Statistics Canada
11:35 AM
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Robust Covariate-Adjusted Multiple Testing
Jianqing Fan, Princeton University; Wen-Xin Zhou, Princeton University; Koushiki Bose, Princeton University; Han Liu, Princeton University
11:50 AM
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Control of False-Positive Rates in Clusterwise fMRI Inferences
Jiangtao Gou, Hunter College of CUNY; Fengqing Zhang, Drexel University
12:05 PM
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SMART: Simultaneous Multistage Adaptive Ranking and Thresholding for Sparse Signal Recovery
Wenguang Sun, University of Southern California; Weinan Wang, University of Southern California
2:05 PM
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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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Incorporation of Stochastic Engineering Models as Prior Information in Bayesian Medical Device Trials
Valentin Parvu, BDX Corporate/Shared services, BD
2:20 PM
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Multiple Testing Procedures in Group Sequential Designs: Comparing Methods and New Proposals
Man Jin, Merck Research
2:20 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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Evolutionary State-Space Model and Its Application to Time-Frequency Analysis of Local Field Potentials
Xu Gao; Babak Shahbaba, University of California, Irvine; Norbert Fortin, University of California, Irvine; Hernando Ombao, KAUST and UC Irvine
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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Causal Estimands in Randomized Trials
Miguel Hernan, Harvard TH Chan School of Public Health
3:05 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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A Data-Driven Approach to the Problem of Multiple Testing
Nasrine Bendjilali, Rowan University; Boualem Bendjilali, RVCC; Wei-Min Huang, Lehigh University
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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A Selective Inference-Based Two-Stage Procedure for Clinical Safety Studies
Yalin Zhu, New Jersey Institute of Technology; Wenge Guo, New Jersey Institute of Technology
3:20 PM
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What's Happening in Selective Inference I?
Emmanuel J. Candes, Stanford University
4:05 PM
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Wednesday, 08/02/2017
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Finite Population Agresti-Coull Based Binomial Confidence Intervals and Excel VBA Function
William Harper, Otterbein University
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Mixed Eff ects Material Strength Models with Model Discrepancy
Jason Bernstein; Kathleeen Schmidt, Lawrence Livermore National Laboratory; Ana Kupresanin, Lawrence Livermore National Laboratory; Jeff Florando, Lawrence Livermore National Laboratory; Nathan Barton, Lawrence Livermore National Laboratory
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A Significant Test for the Number of Orthogonal Components
Zhiyang Zhou, Simon Fraser University; Richard Lockhart, Simon Fraser University
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Unblinded Sample Size Re-Estimation for Complex Trials
Chris Holland, Amgen
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Comparing Quality of Care Across Hospitals: Template Matching Versus Conventional Approaches
Brenda Vincent, VA Center for Clinical Management Research; Hallie Prescott, VA Center for Clinical Management Research
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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
|
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
|
Marginal False Discovery Rates for Penalized Regression Models
Patrick Breheny, University of Iowa
8:35 AM
|
Essential Statistical Methods for Molecular Diagnostics
Jesse Albert Canchola, Roche Molecular Systems Inc.; Pari Hemyari, Roche Molecular Systems Inc.
8:50 AM
|
BAYESIAN PROBABILITY of SUCCESS for MULTIPLE CLINICAL TRIALS in CONTINUOUS OUTCOMES
Junnosuke Matsushima, Chugai Pharma USA
8:50 AM
|
Highest Posterior Mass Prediction Intervals for Binomial and Poisson Distributions
Kalimuthu Krishnamoorthy, Univ of Louisiana
8:50 AM
|
Approximating Probability Distributions in an Extreme Renewal Process
Percy Brill, University of Windsor; Mei Ling Huang, Brock University
8:50 AM
|
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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Increasing Efficiency of Oncology Basket Trials Using a Bayesian Approach
Zheyu Liu, The University of Texas Health Science Center at Houston; Rong Liu, Bayer Healthcare; Mercedeh Ghadessi, Bayer Healthcare; Richardus.vonk Vonk, Bayer Healthcare
9:05 AM
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Estimand Choice and Handling of Treatment Switch in Randomized Clinical Trials
Ulker Aydemir, INC Research
9:05 AM
|
Estimation in Multisite Randomized Trials with Heterogeneous Treatment Effects
Daniel Schwartz, University of Chicago; Stephen Raudenbush, University of Chicago
9:20 AM
|
Hierarchical Latent Factor Models for Improving the Prediction of Surgical Complications Across Hospitals
Elizabeth Lorenzi, Duke University; Katherine Heller, Duke University; Ricardo Henao, Duke University; Zhifei Sun, Duke University
9:35 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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It's All About the Residuals: Estimating Gene Networks by Leveraging Residual Structure in Multi-Tissue Transcriptomic Data
Matthew McCall, University of Rochester Medical Center
9:35 AM
|
Challenges in Identifying and Addressing Sources of Uncertainty in Species classifications of Acoustic bat Calls Used for Monitoring
Katharine Banner, Montana State University; Kathi Irvine, US Geological Survey; Tom Rodhouse, National Park Service; Andrea Litt, Montana State University; Wilson Wright, US Geological Survey
9:35 AM
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Practical Considerations for Designing Pediatric Trials
Jerry Weaver, Celgene
9:50 AM
|
Estimand in Evaluating Predictive or Selection Markers Using Enrichment Design in Clinical Trials
Jingjing Ye, FDA
9:55 AM
|
Empirical Null Estimation Using Zero Inflated Discrete Mixture Distributions and Its Application to Protein Domain Data
Iris Ivy Gauran; Junyong Park, University of Maryland at Baltimore County; DoHwan Park, University of Maryland, Baltimore County; Maricel Kann, University of Maryland, Baltimore County; Thomas Peterson, University of Maryland, Baltimore County; John Zylstra, University of Maryland, Baltimore County; John Spouge, NCBI,NLM,NIH; Johan Lim, Seoul National University
10:05 AM
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What's Happening in Selective Inference II?
Emmanuel J. Candes, Stanford University
10:35 AM
|
Parameter Estimation Based on Stratified Cox Model with Missing Data of Stratified Factors in Small-Sized Trials or Small Strata
Junji Moriya, Kyowa Kirin Pharmaceutical Development, Inc.
10:35 AM
|
A Case Study Exploration of MTPI and Proposed Methods to Expand to Combination Drug Development
Matthew Gribbin, MedImmune; Nairouz Elgeioushi, MedImmune
10:35 AM
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Identifying Individuals with Anterior Cruciate Ligament Injury Through Spectral and Linear Discriminant Analyzes
Kristin Morgan, University of Connecticut; Carolyn Bradshaw Morgan, MECK Limited,LLC; Heather Bush, University of Kentucky; Brian Noehren, University of Kentucky
10:35 AM
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On the Development of a Parametric Approach for the Estimation of Totals and Means for Complex Survey Sample Data in the Presence of Full Response
Ismael Flores Cervantes, Westat
10:50 AM
|
Empirical Bayes Estimation of Gene Expression Fold Change
Abbas Rahal, University of Ottawa; Marta Padilla, University of Ottawa; David R. Bickel, University of Ottawa
10:50 AM
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Coverage properties of 95% confidence intervals for commonly used measures of health disparity implemented in HD*Calc
Jaeil Ahn; George Luta, Georgetown University; Benmei Liu, National Cancer Institute; Eric Feuer, National Cancer Institute ; Mandi Yu, National Cancer Institute; Sam Harper, McGill University
10:55 AM
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Simultaneous Confidence Intervals from Stochastic Approximation
Rongji Mu, East China Normal University; Cui Xiong, East China Normal University; Jin Xu, East China Normal University
10:55 AM
|
Exploratory and Data Visualization Methods for High-Dimensional Brain Signals
Hernando Ombao, KAUST and UC Irvine; Yuxiao Wang, University of California, Irvine; Chee-Ming Ting, KAUST
11:00 AM
|
Likelihood-Ratio and $C(\Alpha)$ Tests for ODE Models
Yuping Yang, Simon Frase University; Richard Lockhart, Simon Fraser University; Jiguo Cao, Simon Frase University
11:05 AM
|
Analyzing Residuals in a Survey Logistic Model with SAS
Bogdan Gadidov, Kennesaw State University
11:05 AM
|
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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Simultaneous Confidence Intervals for Post Model Selection Inference
Xin Gao, York University
11:15 AM
|
Combination Dose Finding in Phase I Oncology Trials: a Co-Data Approach
Niladri Roy Chowdhury, Novartis Oncology Pharmaceuticals; Satrajit Roychoudhury, Pfizer Inc
11:15 AM
|
A Bayesian Approach Developed for Single Arm Studies Using Performance Goals with Subgroups
Wei-Chen Chen, FDA/CDRH; Nelson Lu, CDRH/FDA
11:15 AM
|
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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Confidence Intervals for Population Attributable Fractions Using Complex Survey Data
Akhil Vaish, Research Triangle Institute; Olga Khavjou, Research Triangle Institute
11:35 AM
|
Multiple Contrast Tests and Simultaneous Confidence Intervals in High-Dimensional Repeated Measures Designs
Frank Konietschke, University of Texas at Dallas
11:35 AM
|
Model-based Design for the Early Development of Cancer Immunotherapy Combinations
Nolan Wages, University of Virgina
11:35 AM
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On the Use of Approximate Fiducial Quantities to Construct Confidence Intervals for Measures of Health Disparities
Tengfei Li, Georgetown University; George Luta, Georgetown University
11:35 AM
|
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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Higher Order Influence Functions and Minimax Estimation of Nonlinear Functionals
James Robins, Harvard University; Aad van der Vaart, Universiteit Leiden; Eric Tchetgen Tchetgen, Harvard University ; lingling li, sanofi genzyme; rajarshi mukherjee, stanford
2:05 PM
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Recent Advances in Quality Statistics and Process Validation of Pharmaceuticals
Lynne Hare, Statistical Strategies, LLC
2:25 PM
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Practical Considerations on Simulations for Adaptive Dose Escalation and Dose Ranging Trials
Inna Perevozskaya, Glaxo SmithKline; Alun Bedding, Roche UK; Vladimir Dragalin, Janssen R&D; Parvin Fardipour, ICON
2:25 PM
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Process Validation: Statistical Methods for Evaluating Uniformity of Dosage Units
James Bergum; Thomas Stepinac, Novartis
2:45 PM
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Spatially-Dependent Multiple Testing Under Model Misspecification, with Application to Extreme Event Attribution
Mark Risser, Lawrence Berkeley National Laboratory; Christopher Paciorek, University of California, Berkeley
2:50 PM
|
A Mixed Variance Component Model for Quantifying the Elasticity Modulus of Nanomaterials
Xinwei Deng, Virgiania Tech; Angang Zhang, Virgiania Tech
2:55 PM
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Monotone Distribution Function Estimation in Randomized Trials with Noncompliance
Anqi Cheng, University of Washington
3:05 PM
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Thursday, 08/03/2017
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What's Happening in Selective Inference III?
Emmanuel J. Candes, Stanford University
8:35 AM
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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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Imputation of Ordinal Data in the Agricultural Resource Management Survey Using Bayesian Methods
Christopher Burns, USDA-Economic Research Service; Sujit K Ghosh, North Carolina State University; Daniel Prager, USDA-Economic Research Service; Li Zhang, George Mason University
8:35 AM
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Dynamic Prediction Intervals for Functional Data
Nicholas Rios, Montclair State University; Andrada E. Ivanescu, Montclair State University, Department of Mathematical Sciences
8:35 AM
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Bayesian Design Applications for Medical Devices Trials Using Power Prior
Songtao Jiang, Boston Scientific Corporation; Peter Lam, Boston Scientific Corporation; Hong Wang, Boston Scientific Corporation
8:50 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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Functional Impact of Epigenomic Variation Between Individuals
Kasper Hansen, Johns Hopkins Biostatistics
9:15 AM
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Design of Phase I/II Drug Combination Cancer Trials Using CRM and Adaptive Randomization
Mourad Tighiouart, Cedars-Sinai Medical Center; Matthieu Clertant, Cedars-Sinai Medical Center
9:20 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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Hierarchical Models for Combining N-Of-1 Trials
Youdan Wang
9:35 AM
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COMPLEX SURVEY DESIGNS for SIMULTANEOUS ESTIMATION of TOTALS of TWO SENSITIVE VARIABLES
Segun Ahmed, Texas A & M University-Kingsville; Sarjinder Singh, Texas A&M University-Kingsville; Stephen A. Sedory, Texas A&M University-Kingsville
9:35 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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Advancing Statistics in Universities: Deans' Viewpoints
H. Joeseph Newton, Texas A&M Universtiy; Montserrat Fuentes, Virginia Commonwealth University; Rebecca Doerge, Carnegie-Mellon University ; Sally Morton, Virginia Tech; Sastry Pantula, Oregon State University College of Science
10:35 AM
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Modeling Spatially Correlated and Heteroscedastic Errors in Ethiopian Maize Trials
Tigist Damesa, University of Hohenheim; Hans-Peter Piepho, University of Hohenheim; Jens Möhring, University of Hohenheim; Johannes Forkman, Swedish University of Agricultural Sciences
10:35 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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Residuals and Influence in Bayesian Ensemble Models
Robert McCulloch, Arizona State University; Matthew Pratola, The Ohio State University
11:00 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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What Do Interpolated Nonparametric Confidence Intervals for Population Quantiles Guarantee?
Yimin Zhang, Villanova University; Jesse Frey, Villanova University
11:35 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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