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CC = Vancouver Convention Centre   F = Fairmont Waterfront Vancouver
* = applied session       ! = JSM meeting theme

Activity Details


38
Sun, 7/29/2018, 2:00 PM - 3:50 PM CC-West 119
Study Design: Historical Controls, Endpoint Timing, and Regulatory Considerations — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Dongliang Wang, SUNY Upstate Medical University
2:05 PM Application of Propensity Score Quintile Matching for Baseline Parameters in a Medical Device Trial Design
Presentation
Hong Wang, Boston Scientific Corporation; Songtao Jiang, Boston Scientific; Peter Lam, Boston Scientific
2:20 PM Strategies for Validating Biomarkers Using Data from a Reference Set
Presentation
Lu Wang, Fred Hutchinson Cancer Research Center; Ying Huang, Fred Hutchinson Cancer Research Center
2:35 PM An Adaptive Test of Significance in the Presence of Uncertainty in the Timing of the Final Analysis
Presentation
Jeremy Gorelick, Edwards Lifesciences
2:50 PM Statistical Considerations in Cervical Screening Cytology Device Evaluation
Presentation
Xiaoqin Xiong, Food and Drug Administration
3:05 PM Leveraging Existing Information in Medical Device Clinical Trials
Rajesh Nair, CDRH/FDA; Xuefeng Li, CDRH/FDA; Laura Thompson, CDRH/FDA
3:20 PM Floor Discussion
 
 

150 * !
Mon, 7/30/2018, 10:30 AM - 12:20 PM CC-East 17
Lead with Statistics in Medical Device Innovations and Beyond — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Statistics in Biopharmaceutical Research Journal
Organizer(s): Yunling Xu, FDA/CDRH
Chair(s): Rajesh Nair, CDRH/FDA
10:35 AM Use of Real-World Data and Real-World Evidence for Regulatory Decisions: Opportunities and Challenges
Presentation
Lilly Yue, U.S. Food and Drug Administration; Nelson Lu, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
10:55 AM A Propensity Score Stratified Bayesian Power Prior Approach for Incorporating Real-World Evidence in Single Group Medical Device Clinical Studies
Presentation
Chenguang Wang, John Hopkins University; Ram Tiwari, Center for Devices and Radiologica Health, FDA; Lilly Yue, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
11:15 AM Bayesian Approach for Benefit-Risk Assessment with Examples
Presentation
Ram Tiwari, Center for Devices and Radiologica Health, FDA
11:35 AM Statistics of Counting Molecules for Precision Medicine
Svilen Tzonev
11:55 AM Discussant: Gregory Campbell, GCStat Consulting
12:15 PM Floor Discussion
 
 

278 * !
Tue, 7/31/2018, 8:30 AM - 10:20 AM CC-West 116
Combining Markers for Classification in Practical Tasks — Invited Papers
Section on Medical Devices and Diagnostics, Biometrics Section, Society for Medical Decision Making, SSC
Organizer(s): Andriy Bandos, University of Pittsburgh
Chair(s): Andriy Bandos, University of Pittsburgh
8:35 AM Issues Regarding Biomarker Combination Within ROC Framework: Strategies, Target Functions, and Large Number of Weak Markers
Presentation
Lili Tian, SUNY at Buffalo; Li Yan, Roswell Park Cancer Institute; Jingjing Yin, Georgia Southern University; Le Kang, Virginia Commonwealth University
8:55 AM Robust Combination of Biomarkers for Classification with Covariate Adjustment
Ying Huang, Fred Hutchinson Cancer Research Center; Soyoung Kim, Medical College of Wisconsin
9:15 AM WITHDRAWN: Combining Biomarkers to Improve Classification Accuracy Under Heterogeneous Transformations
Aiyi Liu, BBB/DIPHR/NICHD; Wei Zhang, BBB/DIPHR/NICHD
9:35 AM New Dimension Reduction Methods for Combining Longitudinally Measured Biomarkers
Presentation
Ruth Pfeiffer , National Cancer Institute; Wei Wang , George Washington University ; Efstathia Bura , Vienna University of Technology
9:55 AM Discussant: Ying Lu, Stanford University
10:15 AM Floor Discussion
 
 

300
Tue, 7/31/2018, 8:30 AM - 10:20 PM CC-West 209
SPEED: Statistical Epidemiology — Contributed Speed
Section on Statistics in Epidemiology, Section on Teaching of Statistics in the Health Sciences, Section on Medical Devices and Diagnostics
Chair(s): Jimmy Efird, University of Newcastle
Poster Presentations for this session.
8:35 AM Meta-Analysis of the Difference of Medians
Presentation
Sean McGrath, McGill University; Andrea Benedetti, Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre; Russell Steele, McGill University
8:40 AM Model Validation of Time-To-Event Analyzes via the Concordance Statistic
Samantha-Jo Caetano, McMaster University
8:45 AM A Comparative Longitudinal Study of the Distributions of Observed Versus Estimated Untreated Natural Blood Pressures
Presentation
Saryet Kucukemiroglu
8:50 AM Meta-Analysis of Depression on the Risk of Fracture and Bone Loss in Prospective Cohort Studies
Presentation
Qing Wu, University of Nevada, Las Vegas; Baowen Liu, University of Nevada, Las Vegas; Sajib Tonmoy, University of Nevada, Las Vegas
8:55 AM Expected Versus Observed Effects on Conditional Probability for Clinical Trial Futility Assessment
Presentation
Zhibao Mi, VA CSPCC Perry Point; Kelsey A.L. Alexovitz, VA Cooperative Studies Program Coordinating Center; Xiaoli Lu, VA Cooperative Studies Program Coordinating Center; Kousick Biswas, VA Cooperative Studies Program Coordinating Center; Joseph F Collins, VA Cooperative Studies Program Coordinating Center
9:00 AM Logistic Regression with a Right-Skewed Exposure Variable Measured in Pools and Subject to Errors
Dane R Van Domelen, Rollins School of Public Health, Emory University; Emily M Mitchell, Agency for Healthcare Research and Quality; Enrique F Schisterman, Eunice Kennedy Shriver National Institute of Child Health and Human Development; Neil Perkins, DIPHR/NICHD/NIH; Robert Lyles, Emory University
9:05 AM Invalid Statistical Inference Due to Social Network Dependence
Presentation
Youjin Lee, Johns Hopkins School of Public Health; Elizabeth Ogburn, Johns Hopkins School of Public Health
9:10 AM Compatible Estimates for the Risk Ratio, Odds Ratio, and Risk Difference
Presentation
Charles Rose, CDC
9:15 AM A Joint Model of Opioid Treatment Admissions and Deaths for Adults and Adolescents in Ohio Counties
Presentation
David Kline, Ohio State University; Staci Hepler, Wake Forest University
9:20 AM A Comparison of Some Propensity Score Methods
Presentation
Yuping Wu, Cleveland State University; Amgad Mohammed Alajlan, Cleveland State University
9:30 AM Comparison of Group Testing Algorithms for Clustered Data
Presentation
Ana Best, NIH NCI DCEG Biostatistics Branch; Paul S Albert, National Cancer Institute; Yaakov Malinovsky, University of Maryland Baltimore County Dept. of Mathematics and Statistics
9:35 AM Incorporating Genetic Network into Case-Control Association Studies with High-Dimensional DNA Methylation Data
Presentation
Hokeun Sun, Pusan National University
9:40 AM Application of External Concordance Method
Wenliang Yao, Astrazeneca; Pralay Mukhopadhyay, Astrazeneca
9:45 AM Estimating Memory Decline Among Nondemented Older Adults
Presentation
Wenzhu Mowrey, Albert Einstein College of Medicine; Ellen Grober, Albert Einstein College of Medicine; Molly E Zimmerman, Albert Einstein College of Medicine; Mindy J Katz, Albert Einstein College of Medicine; Charles B Hall, Albert Einstein College of Medicine; Martin J Sliwinski, Pennsylvania State University; Richard B Lipton, Albert Einstein College of Medicine
9:50 AM A Probabilistic Linkage Approach for Combining VA and State Prescription Drug Databases for Evaluating Veterans' Receipt of Long-Term Opioid Therapy Across Multiple Systems
Larry Cook, University of Utah; Tess A Gilbert, HSR&D Center to Improve Veteran Involvement in Care ; Kathleen F Carlson, HSR&D Center to Improve Veteran Involvement in Care
9:55 AM Application of a Method for Identifying Disease Subtypes That Are Etiologically Heterogeneous
Emily Zabor, Memorial Sloan Kettering Cancer Center; Colin B Begg, Memorial Sloan Kettering Cancer Center
 
 

322 * !
Tue, 7/31/2018, 10:30 AM - 12:20 PM CC-West 109
Data-Driven Patient Management in the Era of Precision Medicine - from Discovery, Diagnostics, to Therapeutics — Invited Papers
Council of Chapters, Biopharmaceutical Section, Section on Medical Devices and Diagnostics, SSC
Organizer(s): Ruixiao Lu, Genomic Health, Inc.
Chair(s): Li Zhang, UCSF School of Medicine, UCSF
10:35 AM Big Data Analysis Points Toward New Cancer Therapeutic Discovery Approach
Bin Chen, UCSF
11:00 AM Using Genomic Features to Make Smart Clinical Decisions: The Power of Machine Learning with RNA-Seq
Jing Huang, Veracyte Inc; Su yeon Kim , Veracyte Inc; Yangyang Hao, Veracyte Inc; Jing Lu, Veracyte Inc; Joshua Babiarz, Veracyte Inc; Sean Walsh, Veracyte Inc; Giulia Kennedy, Veracyte Inc
11:25 AM Developing Genomic Biomarker to Guide Personalized Patient Management in Oncology: Validity and Utility of Clinical Diagnostic Applications
Presentation
Michael Crager, Genomic Health; Ruixiao Lu, Genomic Health, Inc.
11:50 AM Biomarker-Defined Subgroup Selection Adaptive Design for Phase III Confirmatory Trial
Presentation
Rui Tang, Shire; Xiaoye Ma, University of Minnesota; Hui Yang, Amgen Inc.
12:15 PM Floor Discussion
 
 

364
Tue, 7/31/2018, 10:30 AM - 12:20 PM CC-West Hall B
Contributed Poster Presentations: Section on Medical Devices and Diagnostics — Contributed Poster Presentations
Section on Medical Devices and Diagnostics
Chair(s): Paul McNicholas, McMaster University
77: Preventing False Discovery of Heterogeneous Treatment Effect Subgroups in Randomized Trials
Joseph Rigdon, Stanford University; Michael Baiocchi, Stanford University; Sanjay Basu, Stanford University School of Medicine
78: Using Stratified Propensity Score Matching Approach to Adjust Risk Assessment for Breast Reconstruction Patients
Jun Liu, UT MDACC; Liang Li, UT MD Anderson Cancer Center; Summer Elizabeth Summer, UT MDACC; Victor Joseph Hassid, UT MDACC; Jesse Creed Selber, UT MDACC; Charles Butler, UT MDACC; Patrick Bryan Garvey, UT MDACC; Donald Baumann, UT MDACC
79: Statistical Analysis of Radiomics Data
Samantha Morrison, Brown University; Firas Ahmed, Columbia University; Lin Lu, Columbia University; Constantine Gatsonis, Brown University; Binsheng Zhao, Columbia University
80: Parametric and Non-Parametric Statistical Methods to Detect Sleep Patterns from Accelerometer Data
Margaret Banker, University of Michigan
81: Bayesian Hierarchical Models for Voxel-Wise Classification of Prostate Cancer Using Nearest-Neighbor Gaussian Process
Jin Jin, Division of Biostatistics, University of Minnesota; Joseph Koopmeiners, Division of Biostatistics, University of Minnesota; Gregory Metzger, University of Minnesota; Ethan Leng, University of Minnesota
82: Visualizing Lupus Symptom Clusters
Lauren Taylor Washington, Purdue University; Vetria Byrd, Purdue University
 
 

367
Tue, 7/31/2018, 11:35 AM - 12:20 PM CC-West Hall B
SPEED: Statistical Epidemiology — Contributed Poster Presentations
Section on Statistics in Epidemiology, Section on Teaching of Statistics in the Health Sciences, Section on Medical Devices and Diagnostics
Chair(s): Paul McNicholas, McMaster University
Oral Presentations for this session.
1: Meta-Analysis of the Difference of Medians
Sean McGrath, McGill University; Andrea Benedetti, Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre; Russell Steele, McGill University
2: Model Validation of Time-To-Event Analyzes via the Concordance Statistic
Samantha-Jo Caetano, McMaster University
3: A Comparative Longitudinal Study of the Distributions of Observed Versus Estimated Untreated Natural Blood Pressures
Saryet Kucukemiroglu
4: Meta-Analysis of Depression on the Risk of Fracture and Bone Loss in Prospective Cohort Studies
Qing Wu, University of Nevada, Las Vegas; Baowen Liu, University of Nevada, Las Vegas; Sajib Tonmoy, University of Nevada, Las Vegas
5: Expected Versus Observed Effects on Conditional Probability for Clinical Trial Futility Assessment
Zhibao Mi, VA CSPCC Perry Point; Kelsey A.L. Alexovitz, VA Cooperative Studies Program Coordinating Center; Xiaoli Lu, VA Cooperative Studies Program Coordinating Center; Kousick Biswas, VA Cooperative Studies Program Coordinating Center; Joseph F Collins, VA Cooperative Studies Program Coordinating Center
6: Logistic Regression with a Right-Skewed Exposure Variable Measured in Pools and Subject to Errors
Dane R Van Domelen, Rollins School of Public Health, Emory University; Emily M Mitchell, Agency for Healthcare Research and Quality; Enrique F Schisterman, Eunice Kennedy Shriver National Institute of Child Health and Human Development; Neil Perkins, DIPHR/NICHD/NIH; Robert Lyles, Emory University
7: Invalid Statistical Inference Due to Social Network Dependence
Youjin Lee, Johns Hopkins School of Public Health; Elizabeth Ogburn, Johns Hopkins School of Public Health
8: Compatible Estimates for the Risk Ratio, Odds Ratio, and Risk Difference
Charles Rose, CDC
9: A Joint Model of Opioid Treatment Admissions and Deaths for Adults and Adolescents in Ohio Counties
David Kline, Ohio State University; Staci Hepler, Wake Forest University
10: A Comparison of Some Propensity Score Methods
Yuping Wu, Cleveland State University; Amgad Mohammed Alajlan, Cleveland State University
11: Comparison of Group Testing Algorithms for Clustered Data
Ana Best, NIH NCI DCEG Biostatistics Branch; Paul S Albert, National Cancer Institute; Yaakov Malinovsky, University of Maryland Baltimore County Dept. of Mathematics and Statistics
12: Incorporating Genetic Network into Case-Control Association Studies with High-Dimensional DNA Methylation Data
Hokeun Sun, Pusan National University
13: Application of External Concordance Method
Wenliang Yao, Astrazeneca; Pralay Mukhopadhyay, Astrazeneca
14: Estimating Memory Decline Among Nondemented Older Adults
Wenzhu Mowrey, Albert Einstein College of Medicine; Ellen Grober, Albert Einstein College of Medicine; Molly E Zimmerman, Albert Einstein College of Medicine; Mindy J Katz, Albert Einstein College of Medicine; Charles B Hall, Albert Einstein College of Medicine; Martin J Sliwinski, Pennsylvania State University; Richard B Lipton, Albert Einstein College of Medicine
15: A Probabilistic Linkage Approach for Combining VA and State Prescription Drug Databases for Evaluating Veterans' Receipt of Long-Term Opioid Therapy Across Multiple Systems
Larry Cook, University of Utah; Tess A Gilbert, HSR&D Center to Improve Veteran Involvement in Care ; Kathleen F Carlson, HSR&D Center to Improve Veteran Involvement in Care
16: Application of a Method for Identifying Disease Subtypes That Are Etiologically Heterogeneous
Emily Zabor, Memorial Sloan Kettering Cancer Center; Colin B Begg, Memorial Sloan Kettering Cancer Center
Oral Presentations for this session.
 
 

420 *
Tue, 7/31/2018, 2:00 PM - 3:50 PM CC-West 202
Biomarker Evaluation — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Lili Tian, SUNY at Buffalo
2:05 PM New Method of Evaluation of Limit of Detection (LoD) in Molecular Diagnostics
Presentation
Jeffrey Vaks, Roche Molecular Diagnostics
2:20 PM Estimating the Receiver Operating Characteristic Curve from Clustered Data and Case-Control Studies
Presentation
Yalda Zarnegarnia, University of Miami; Shari Messinger, University of Miami
2:35 PM A Comprehensive/Comparative Review of Cut-Point Selection Methods for Multiple Class Settings
Jia Hua, State University of New York At Buffalo; Lili Tian, SUNY at Buffalo
2:50 PM Dynamic Prediction for Patients with High-Grade Extremity Soft Tissue Sarcoma
Anja Rueten-Budde, Leiden University; Marta Fiocco, Leiden University
3:05 PM Evaluation of Therapeutic Effect in Clinical Study Using Companion Diagnostic Device for Patient Screening
Presentation
Jeng Mah, Beckman Coulter
3:20 PM Confidence intervals to compare optimal performance in multi-State diagnostic tests with correlated Biomarkers 
Presentation
Beau Nunnally, Air Force Institute of Technology; Christine M Schubert, Air Force Institute of Technology; Katherine A Batterton, Air Force Institute of Technology
3:35 PM Inference for Youden's Index with Varying Prevalence
Christine Schubert Kabban, Air Force Institute of Technology; Katherine A Batterton, Air Force Institute of Technology; Richard Warr, Brigham Young University
 
 

Register 441
Wed, 8/1/2018, 7:00 AM - 8:15 AM CC-West Ballroom D
CANCELED: Section on Medical Devices and Diagnostics A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Section on Medical Devices and Diagnostics
Organizer(s): Martin Ho, FDA
 
 

527
Wed, 8/1/2018, 10:30 AM - 12:20 PM CC-West 208
Diagnostic Tests: Student Papers and Correlated Data — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Jin Jin, Division of Biostatistics, University of Minnesota
10:35 AM Bayesian and Influence Function Based Empirical Likelihoods for Inference of Sensitivity in Diagnostic Tests
Yan Hai, Georgia State University; Gengsheng Qin, Georgia State University; Xiaoyi Min, Georgia State University
10:50 AM FAST Adaptive Smoothing and Thresholding for Improved Activation Detection in Low-Signal fMRI
Presentation
Israel Almodovar-Rivera, University of Puerto Rico-Medical Science Campus; Ranjan Maitra, Iowa State University
11:05 AM A New Half-Marginal Approach for Analyzing Cross-Correlated Binary Data from Multi-Reader Studies of Diagnostic Accuracy
Presentation
Yuvika Paliwal, Teva Pharmaceuticals; Andriy Bandos, University of Pittsburgh
11:20 AM On Statistical Inference in Factorial Multi-Reader Studies Using Bootstrap
Presentation
Andriy Bandos, University of Pittsburgh
11:35 AM Methods for Diagnostic Performance Comparison with Correlated Data
Presentation
Xuan Ye, U.S. Food and Drug Administration
11:50 AM Comparison of Two Methods for Evaluating Bias in Method Comparison Studies
Kyungsook Kim, FDA
12:05 PM Floor Discussion
 
 

216613
Wed, 8/1/2018, 1:00 PM - 2:00 PM F-Burrard Suite
Section on Medical Devices and Diagnostics Officer Meeting (Invitation Only) — Other Cmte/Business
Section on Medical Devices and Diagnostics
Chair(s): Xiting Yang, Food and Drug Administration
 
 

575 *
Wed, 8/1/2018, 2:00 PM - 3:50 PM CC-West 214
Translating Real World Data into Robust Evidence to Inform Decisions on Medical Product Development and Life Cycle Management — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section
Organizer(s): Weili He, AbbVie
Chair(s): Weili He, AbbVie
2:05 PM Evaluating Different Analytic Strategies to Translate Real World Data to Robust Evidence for Decision Making
Presentation
Hongwei Wang, AbbVie Inc; Weili He, AbbVie; Yabing Mai, AbbVie, Inc; Meijing Wu, AbbVie; Dajun Tian, Chiltern
2:25 PM Opportunities of Using Real World Data to Inform Regulatory Considerations for Medical Devices
Presentation
Martin Ho, FDA
2:45 PM Real World Data Analysis to Inform Clinical Trial Modeling and Simulation
Presentation
Zhaoling Meng, sanofi; Dimple Patel, sanofi; Qi Tang, Sanofi; Nadia Gaudel-Dedieu, sanofi; James Rogers, Metrum Research Group
3:05 PM The Use of Real World Data as a Bayesian Prior in a Device Clinical Trial
Presentation
Roseann White, Duke Clinical Research Institute
3:25 PM Discussant: Mark Levenson, FDA CDER
3:45 PM Floor Discussion
 
 

216612
Wed, 8/1/2018, 6:00 PM - 7:30 PM CC-West 111
Section on Medical Devices and Diagnostics Business Meeting — Other Cmte/Business
Section on Medical Devices and Diagnostics
Chair(s): Xiting Yang, Food and Drug Administration
 
 

676 *
Thu, 8/2/2018, 10:30 AM - 12:20 PM CC-West 221
Analysis and Reporting: Benefit-Risk and Robust Models — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Kyungsook Kim, FDA
10:35 AM Real Data Applications of Learning Curves in Cardiac Devices and Procedures
Presentation
Usha Govindarajulu, SUNY Downstate School of Public Health; David Goldfarb, Montfiore Medical Center; Frederic Resnic, Lahey Clinic
10:50 AM Screening for Depression in Arthritis Populations in Self-Reported Questionnaire
Presentation
Jinxiang Hu, University of Kansas Medical Center
11:05 AM Methods to improve glucose variability estimates from censored data in patients with insulin dependent T1DM
Presentation
Nicholas Hein, University of Nebraska Medical Center; Christopher Wichman, University of Nebraska Medical Center; Lynette Smith, University of Nebraska Medical Center; Jennifer Merickel, University of Nebraska Medical Center; Andjela Drincic, University of Nebraska Medical Center; Matthew Rizzo, University of Nebraska Medical Center; Cyrus Desouza, University of Nebraska Medical Center
11:20 AM Nonparametric Inference for the Coefficient of Variation
Presentation
Dongliang Wang, SUNY Upstate Medical University; Margaret Formica , SUNY Upstate Medical University; Song Liu, Roswell Park Cancer Institute
11:35 AM Improved Modeling of Imbalanced Data for Dietary Lapse Prediction
Fengqing Zhang, Drexel University; Tinashe M Tapera , Drexel University; Stephanie P Goldstein, Drexel University; Evan Forman, Drexel University
11:50 AM Targeted Learning for Variable Importance in Precision Medicine
Yue You, Division of Biostatistics, University of California, Berkeley; Alan Hubbard, Division of Biostatistics, University of California, Berkeley; Rachael Callcut, Zuckerberg San Francisco General Hospital, University of California; Lucy Kornblith, Zuckerberg San Francisco General Hospital, UCSF; Sabrinah Christie, Zuckerberg San Francisco General Hospital, UCSF
12:05 PM A Bayesian Approach to Benefit-Risk Assessment for Ophthalmic Devices
Chul Ahn, FDA-CDRH