Legend:
CC = Baltimore Convention Center,
H = Hilton Baltimore
* = applied session ! = JSM meeting theme
Activity Details
28
Sun, 7/30/2017,
2:00 PM -
3:50 PM
CC-319
Personalized Medicine — Contributed Papers
Biometrics Section , Section on Statistics in Genomics and Genetics , Section on Medical Devices and Diagnostics
Chair(s): Jeffrey Miller, Harvard School of Public Health
2:05 PM
Wearable Devices in Clinical Trials
—
Greg Hather, Takeda Pharmaceuticals ; Ray Liu, Takeda Pharmaceuticals
2:20 PM
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
2:35 PM
Determining Personalized Dosing Intervals
—
Xiaomao Li, university of wisconsin-madison ; Jun Shao, university of wisconsin-madison ; Menggang Yu, university of wisconsin-madison
2:50 PM
Constructing a Confidence Interval for the Fraction Who Benefit from Treatment Using Randomized Trial Data
—
Emily Huang, Johns Hopkins University Department of Biostatistics ; Ethan Fang, Pennsylvania State University ; Daniel Hanley, Johns Hopkins Division of Brain Injury Outcomes ; Michael Rosenblum, Johns Hopkins University
3:05 PM
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
3:20 PM
Data Sharing for Validation of High-Throughput Chemical Screening Experiments of Cancer Cell Lines
—
Hongmei Liu, University of Miami ; J. Sunil Rao, University of Miami
3:35 PM
A Mixture of Mixed Logistic Regression Models for Determining Optimal Dynamic Treatment Regimes
—
Bing Yu ; Bruce Craig, Purdue University ; Michael Yu Zhu, Purdue University
60 * !
Sun, 7/30/2017,
4:00 PM -
5:50 PM
CC-316
Adaptive Design and Statistical Consideration in Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section , Section on Statistical Computing , Section on Medical Devices and Diagnostics
Organizer(s): Grace Liu, Johnson & Johnson
Chair(s): Grace Liu, Johnson & Johnson
4:05 PM
Investigation on Combining Phase II Proof-Of-Concept Trial with Dose Finding Trial
—
Yutao Liu, Columbia University ; Qiqi Deng, Boehringer Ingelheim Pharmaceuticals, Inc. ; Ken Cheung, Deptment of Biostatistics, Columbia University
4:25 PM
Adaptive Design and Statistical Consideration in Clinical Trials
—
Steven Sun ; Grace Liu, Johnson & Johnson ; Tianmeng Lyu, Univ. Minnesota Biostatistics Dept.
4:45 PM
Basket Trial Considerations in Phase Ib/IIa Oncology Studies of Targeted Therapy
—
Yihua Zhao, Boehringer Ingelheim Pharmaceuticals, Inc.
5:05 PM
Evaluation of Adaptive Sample Size Re-estimation (SSR) Designs:start small then ask for more?
—
Chaofeng Liu
5:25 PM
Design of Dose Finding Studies Under MCP-Mod
—
Jose Pinheiro, Johnson & Johnson
Discussant: Sudhakar Rao
5:45 PM
Floor Discussion
126 *
Mon, 7/31/2017,
8:30 AM -
10:20 AM
CC-342
Diagnostics, Classification, and Agreement — Contributed Papers
Section on Medical Devices and Diagnostics , Section on Statistics in Imaging
Chair(s): Gene Pennello, Food and Drug Administration
8:35 AM
Detection of Prostate Cancer with Multi-Parametric MR Imaging Models Utilizing the Anatomic Structure of the Prostate
—
Jin Jin, University of Minnesota ; Joseph Koopmeiners, University of Minnesota ; Lin Zhang, University of Minnesota ; Greg Metzger, University of Minnesta ; Ethan Leng, University of Minnesta
8:50 AM
Overall Unscaled Indices for Assessing Agreement Among Multiple Raters
—
Jeong Hoon Jang, Emory University ; Amita Manatunga, Emory University ; Qi Long, University of Pennsylvania
9:05 AM
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
9:20 AM
Does Correlation Matter: The Influence of Correlation on Diagnostic Test Performance at the Optimal Point
—
Beau Nunnally, Air Force Institute of Technology ; Christine M Schubert, Air Force Institute of Technology/ENC ; Katherine A Batterton, Air Force Institute Technology
9:35 AM
Sample Size and Confidence Interval Planning for Estimating the Optimal Thresholds in a Sequence of Diagnostic Tests
—
Christine M Schubert, Air Force Institute of Technology/ENC ; Donna McClish, VCU ; Amber R Wilk, Virginia Commonwealth University
9:50 AM
Choosing Between the BP and BN Sequential Strategies
—
Donna McClish, VCU ; Christine Schubert Kabban, Air Force Institute of Technology ; Amber R Wilk, Virginia Commonwealth University
10:05 AM
Evaluating Classification Performance of Biomarkers in Two-Phase Case-Control Studies
—
Lu Wang, Fred Hutchinson Cancer Research Center ; Ying Huang, Fred Hutchinson Cancer Research Center
216 *
Mon, 7/31/2017,
2:00 PM -
3:50 PM
CC-328
Statistical Opportunities in Disease Interception: Screening, Intervening, and Evaluating Benefit-Risk Trade-Offs — Topic Contributed Papers
Section on Medical Devices and Diagnostics , Section on Statistics in Epidemiology , Section on Risk Analysis
Organizer(s): Rachael L. DiSantostefano, Janssen R&D
Chair(s): Bennett Levitan, Janssen R&D
2:05 PM
A Risk Stratification Approach for Improved Interpretation of Diagnostic Accuracy Statistics
—
Hormuzd Katki, National Cancer Institute ; Mark Schiffman, National Cancer Institute
2:25 PM
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
2:45 PM
Personalizing Early Detection for Alzheimer's Disease: Biomarker Assessment in the Absence of a Gold Standard
—
Zheyu Wang, Johns Hopkins University ; Yanxun Xu, Johns Hopkins University ; Marilyn Albert, Johns Hopkins University
3:05 PM
Alzheimer's Intervention Case Study: Patient Preferences and Benefit-Risk Tradeoffs in Interception of Alzheimer's Disease
—
Rachael L. DiSantostefano, Janssen R&D ; Shelby Reed, Duke University ; Reed Johnson, Duke University ; Jui-Chen Yang, Duke University ; Johannes Streffer, Janssen R&D ; Bennett Levitan, Janssen R&D
3:25 PM
Evaluating Risk Prediction Tests to Guide Decisions on Prophylactic Treatment
—
Gene Pennello, Food and Drug Administration ; Robert L Becker, Food and Drug Administration
3:45 PM
Floor Discussion
223 * !
Mon, 7/31/2017,
2:00 PM -
3:50 PM
CC-315
Clinical Trials: Recent Statistical Advances for Enabling Personalized Medicine — Topic Contributed Papers
Biopharmaceutical Section , Section on Statistics in Genomics and Genetics , Section on Medical Devices and Diagnostics
Organizer(s): Devan Mehrotra, Merck & Co. Inc.
Chair(s): Donna L Kowalski, Astellas Pharma, US
2:05 PM
Methods of Biomarker and Subgroup Identification for Personalized Medicine
—
Ilya Lipkovich, QuintilesIMS ; Bohdana Ratitch , QuintilesIMS ; Alex Dmitrienko, Mediana Inc
2:25 PM
Measuring Differential Treatment Benefit Across Marker Specific Subgroups: The Choice of Outcome Scale
—
Alexia Iasonos, Memorial Sloan Kettering Sloan Cancer Center ; Jaya Satagopan, Memorial Sloan Kettering Cancer Center
2:45 PM
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.
3:05 PM
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
3:25 PM
Clinical Trial Designs of Predictive Markers
—
Meijuan Li, CDRH/FDA
3:45 PM
Floor Discussion
244
Mon, 7/31/2017,
2:00 PM -
3:50 PM
CC-Halls A&B
Contributed Poster Presentations: Section on Medical Devices and Diagnostics — Contributed Poster Presentations
Section on Medical Devices and Diagnostics , Section on Statistics in Imaging
Chair(s): Jessi Cisewski, Yale University
50:
Implications for Gamma Characteristic of Reconstructed PET Data
—
Tian Mou, University College Cork ; Jian Huang, University College Cork ; Finbarr O'Sullivan, University College Cork
51:
Impact of Missing Data in Feature Selection
—
Carmen Khoo
52:
An Algorithm for Detecting Melanoma Based on Imaging Biomarkers
—
Joel Correa da Rosa, Rockefeller University ; Amanda Zong, The Rockefeller University ; Daniel Gareau, The Rockefeller University
53:
Quality Control of Blood Sample Analysis for Transplant Patients
—
Margaret Christy ; Mark Ward, Purdue University ; David Ross, CareDx, Inc. ; Sarah Wang, CareDx, Inc. ; Pazit Sankey, CareDx, Inc. ; Susan Scott, CareDx, Inc.
285 * !
Tue, 8/1/2017,
8:30 AM -
10:20 AM
CC-304
Enhance Risk Assessment Through Novel Statistical Measures and Methods for Complex Time-to-Event Data — Topic Contributed Papers
Section on Risk Analysis , Section on Medical Devices and Diagnostics
Organizer(s): Ying Ding, University of Pittsburgh
Chair(s): Joyce Chang, University of Pittsburgh
8:35 AM
Semiparametric Regression on Life Lost
—
Lauren Balmert, University of Pittsburgh ; Jong H. Jeong, University of Pittsburgh
8:55 AM
Estimating the Effect of a Time-Dependent State Change on Correlated Recurrent and Terminal Events
—
Douglas Earl Schaubel, University of Michigan ; Abigail R. Smith, Arbor Research Collaborative for Health
9:15 AM
Risk Screening for Alzheimer's Disease Progression with Volume Under the ROC Surface
—
Yu Cheng, University of Pittsburgh Department of Statistics
9:35 AM
Quantile Residual Life Regression with Longitudinal Biomarker Measurements for Dynamic Prediction
—
Ruosha Li, University of Texas Health Science Center at Houston ; Xuelin Huang, M D Anderson Cancer Center
9:55 AM
Progression Risk Prediction with Copula Model in Age-Related Macular Degeneration (AMD) Patients
—
Ying Ding, University of Pittsburgh ; Yi Liu ; Wei Chen, University of Pittsburgh
10:15 AM
Floor Discussion
333
Tue, 8/1/2017,
10:30 AM -
12:20 PM
CC-323
SPEED: Biopharmaceutical Statistics, Medical Devices, and Mental Health — Contributed Speed
Biopharmaceutical Section , Section on Medical Devices and Diagnostics , Mental Health Statistics Section , Social Statistics Section , International Indian Statistical Association
Chair(s): Abie Ekangaki, UCB Biopharma SPRL
10:35 AM
Missing Data Imputation Strategies for Different Estimands in Clinical Trials
—
Ye Tan, Pfizer ; Steven Gilbert, Pfizer Inc.
10:40 AM
A Case Study Evaluating Time Varying Covariate and Competing Risk for Efficacy Evaluation in Survival Analyses
—
Yang Xu, BioStat Solutions, Inc.
10:50 AM
Subgroup Analyzes with Survival Data in Retrospective Cohort Studies
—
Rima Izem, Food and Drug Administration ; Jiemin Lao, Sphere Institute ; Mao Hu, Acumen LLC ; Yuqin Wei, Sphere Institute ; Michael Wernecke, Acumen LLC ; Jeffrey A Kelman, Centers for Medicaid and Medicare Services (CMS) ; David J Graham, Food and Drug Administration
10:55 AM
Social Media and Clinical Trials
—
Darcy Hille, Merck ; T. Ceesay, Merck & Co, Inc.
11:00 AM
Propensity Score Methods for Analysis Time-To-Event Data
—
Haiying Lin
11:05 AM
Modeling Transcranial Magnetic Stimulation-Driven Stimulus-Response Curves
—
Caitlin I. Steiner, Department of Statistics, University of Virginia ; Sahana N. Kukke, Department of Biomedical Engineering, The Catholic University of America ; Nivethida Thirugnanasambandam, Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological ; Mark Hallett, Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological ; Daniel M. Keenan, Department of Statistics, University of Virginia
11:10 AM
Parsimonious Modeling for Kinematic Data
—
Md Islam, North Carolina State University ; Jonathan W. Stallings, North Carolina State University
11:20 AM
Developing a Performance Sustaining Decoder for a Brain Computer Interface Controlled Neuroprosthetic Device
—
David Friedenberg, Battelle Memorial Institute ; Mingming Zhang, Battelle ; Michael Schwemmer, Battelle ; Nick Annetta, Battelle ; Marcia Bockbrader, Center for Neuromodulation, The Ohio State University & Department of Physical Medicine an ; Chad Bouton, Battelle (currently at Feinstein Institute for Medical Research) ; Ali Rezai, Center for Neuromodulation, The Ohio State University ; W. Jerry Mysiw, Department of Physical Medicine and Rehabilitation, The Ohio State University ; Herbert Bresler, Battelle ; Gaurav Sharma, Battelle
11:25 AM
Combining Different Data Sources in Accelerometry Study
—
Jiawei Bai, Johns Hopkins University ; Chongzhi Di, Fred Hutchinson Cancer Research Center ; Ciprian M Crainiceanu, Johns Hopkins University
11:30 AM
Repeated Cross-Sectional Surveys: Accounting for Instrumentation Changes
—
John Bunker, RTI International ; Marcus Berzofsky, RTI International
11:35 AM
Survival Analysis on a Social Network
—
SONG Fangda, The Chinese University of Hong Kong ; Yingying Wei, The Chinese University of Hong Kong
11:40 AM
Social Network Impact on Family Planning Use in Benin
—
Theresa Y Kim, Maryland Population Research Center ; Kimberly A Ashburn, Elizabeth Glaser Pediatric AIDS Foundation ; Rebecka I Lundgren, Institute for Reproductive Health, Georgetown University ; Susan M Igras, Institute for Reproductive Health, Georgetown University
11:45 AM
Assessing the Combination of Evidence Through a Probabilistic Graphical Model
—
Amanda Luby, Carnegie Mellon University ; Anjali Mazumder, Carnegie Mellon University
11:50 AM
Identifying Latent Structures in Restricted Latent Class Models
—
Zhuoran Shang, University of Minnesota ; Gongjun Xu, University of Michigan
11:55 AM
On the Hazard Function of Kumaraswamy Distribution and Associated Inference
—
Rajarshi Dey, University of South Alabama ; Nutan Mishra, University of south alabama
12:00 PM
Floor Discussion
382
Tue, 8/1/2017,
2:00 PM -
3:50 PM
CC-308
Improving the Efficiency of Medical Device Clinical Trials by Combining Simulations and Experiments — Invited Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , Society for Medical Decision Making
Organizer(s): Rajesh Nair, FDA/CDRH/OSB/DBS
Chair(s): Tarek Haddad, Medtronic Cardiac Rhythm and Heart Failure
2:05 PM
The Past Is Prologue: The Use of Prior Information and Bayesian Methodologies in Designing Medical Device Regulatory Approval Trial
—
Roseann White, Pragmatic clinical trial Statistics, Duke Clinical Research Institute
2:20 PM
Incorporation of Stochastic Engineering Models as Prior Information in Bayesian Medical Device Trials
—
Valentin Parvu, BDX Corporate/Shared services, BD
2:35 PM
Discussant: Telba Irony, Office of Biostatistics and Epidemiology, CBER, FDA
2:50 PM
Discussant: Kyle Myers, Office of Science and Engineering Laboratories, CDRH
3:05 PM
Discussant: Scott Evans, Harvard University
3:20 PM
Discussant: Greg Campbell, GC stat consulting and former Director DBS/CDRH
3:35 PM
Floor Discussion
423
Tue, 8/1/2017,
2:00 PM -
2:45 PM
CC-Halls A&B
SPEED: Biopharmaceutical Statistics, Medical Devices, and Mental Health — Contributed Poster Presentations
Biopharmaceutical Section , Section on Medical Devices and Diagnostics , Mental Health Statistics Section , International Indian Statistical Association , Social Statistics Section
Chair(s): Jessi Cisewski, Yale University
21:
Missing Data Imputation Strategies for Different Estimands in Clinical Trials
—
Ye Tan, Pfizer ; Steven Gilbert, Pfizer Inc.
22:
A Case Study Evaluating Time Varying Covariate and Competing Risk for Efficacy Evaluation in Survival Analyses
—
Yang Xu, BioStat Solutions, Inc.
24:
Subgroup Analyzes with Survival Data in Retrospective Cohort Studies
—
Rima Izem, Food and Drug Administration ; Jiemin Lao, Sphere Institute ; Mao Hu, Acumen LLC ; Yuqin Wei, Sphere Institute ; Michael Wernecke, Acumen LLC ; Jeffrey A Kelman, Centers for Medicaid and Medicare Services (CMS) ; David J Graham, Food and Drug Administration
25:
Social Media and Clinical Trials
—
Darcy Hille, Merck ; T. Ceesay, Merck & Co, Inc.
26:
Propensity Score Methods for Analysis Time-To-Event Data
—
Haiying Lin
27:
Modeling Transcranial Magnetic Stimulation-Driven Stimulus-Response Curves
—
Caitlin I. Steiner, Department of Statistics, University of Virginia ; Sahana N. Kukke, Department of Biomedical Engineering, The Catholic University of America ; Nivethida Thirugnanasambandam, Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological ; Mark Hallett, Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological ; Daniel M. Keenan, Department of Statistics, University of Virginia
28:
Parsimonious Modeling for Kinematic Data
—
Md Islam, North Carolina State University ; Jonathan W. Stallings, North Carolina State University
29:
Developing a Performance Sustaining Decoder for a Brain Computer Interface Controlled Neuroprosthetic Device
—
David Friedenberg, Battelle Memorial Institute ; Mingming Zhang, Battelle ; Michael Schwemmer, Battelle ; Nick Annetta, Battelle ; Marcia Bockbrader, Center for Neuromodulation, The Ohio State University & Department of Physical Medicine an ; Chad Bouton, Battelle (currently at Feinstein Institute for Medical Research) ; Ali Rezai, Center for Neuromodulation, The Ohio State University ; W. Jerry Mysiw, Department of Physical Medicine and Rehabilitation, The Ohio State University ; Herbert Bresler, Battelle ; Gaurav Sharma, Battelle
30:
Combining Different Data Sources in Accelerometry Study
—
Jiawei Bai, Johns Hopkins University ; Chongzhi Di, Fred Hutchinson Cancer Research Center ; Ciprian M Crainiceanu, Johns Hopkins University
31:
Repeated Cross-Sectional Surveys: Accounting for Instrumentation Changes
—
John Bunker, RTI International ; Marcus Berzofsky, RTI International
32:
Survival Analysis on a Social Network
—
SONG Fangda, The Chinese University of Hong Kong ; Yingying Wei, The Chinese University of Hong Kong
33:
Social Network Impact on Family Planning Use in Benin
—
Theresa Y Kim, Maryland Population Research Center ; Kimberly A Ashburn, Elizabeth Glaser Pediatric AIDS Foundation ; Rebecka I Lundgren, Institute for Reproductive Health, Georgetown University ; Susan M Igras, Institute for Reproductive Health, Georgetown University
34:
Assessing the Combination of Evidence Through a Probabilistic Graphical Model
—
Amanda Luby, Carnegie Mellon University ; Anjali Mazumder, Carnegie Mellon University
35:
Identifying Latent Structures in Restricted Latent Class Models
—
Zhuoran Shang, University of Minnesota ; Gongjun Xu, University of Michigan
36:
On the Hazard Function of Kumaraswamy Distribution and Associated Inference
—
Rajarshi Dey, University of South Alabama ; Nutan Mishra, University of south alabama
The Speed portion will take place during Session 214535
438 * !
Wed, 8/2/2017,
8:30 AM -
10:20 AM
CC-308
Real-World Evidence in Clinical Trial: New Era of Informed Decision Making Session — Invited Papers
Biopharmaceutical Section , Health Policy Statistics Section , Society for Medical Decision Making , Section on Medical Devices and Diagnostics
Organizer(s): Satrajit Roychoudhury, Pfizer Inc
Chair(s): Margaret Gamalo-Siebers, Eli Lilly
8:35 AM
Real World Evidence to Support Accelerated Approval Processes
—
Sebastian Schneeweiss, Harvard Medical School ; Jessica Franklin, Harvard Medical School
9:00 AM
Assessing the impact of informative censoring on overall survival in a RWD source.
—
Bill Capra, Genentech Inc. ; Gillis Carrigan, Genentech Inc. ; Michael Taylor, Genentech Inc. ; Brandon Arnieri, Genentech Inc. ; Melissa Curtis, Flatiron Health ; Sandy Griffith, Flatiron Health ; Aracelis Torres, Flatiron Health ; Philip Hofmeister, Flatiron Health ; Anala Gossai, Flatiron Health ; Samuel Whipple, Genentech Inc ; Peter Lambert, Genentech Inc
9:25 AM
Statistical Design Considerations for Utilizing Real World Data in Premarket Evaluation of Medical Devices
—
Yunling Xu, CDRH/FDA ; Nelson Lu, CDRH/FDA ; Lilly Yue, Division of Biostatistics, CDRH/ U.S. FDA ; Ram Tiwari, FDA/CDRH
9:50 AM
Discussant: Douglas E Faries, Eli Lilly
10:15 AM
Floor Discussion
471 *
Wed, 8/2/2017,
8:30 AM -
10:20 AM
CC-320
Statistical Methods and Challenges in Diagnostic Medicine — Contributed Papers
Section on Medical Devices and Diagnostics , Section on Statistics in Genomics and Genetics
Chair(s): Allison Meisner, University of Washington
8:35 AM
Passing-Bablok Regression Analysis with Rank-Transferred Data in Evaluating Hemostasis State of a Blood Sample
—
Kyungsook Kim, FDA
8:50 AM
Essential Statistical Methods for Molecular Diagnostics
—
Jesse Albert Canchola, Roche Molecular Systems Inc. ; Pari Hemyari, Roche Molecular Systems Inc.
9:05 AM
Probability of Detection of Target Nucleic Acid Sequence with PCR Assay in Molecular Diagnostics: Math Model Derivation, Validation and Applications
—
Jeffrey Vaks, Roche Molecular Diagnostics
9:20 AM
Variant Call Differences Between Paired Reads in Illumina Amplicon Sequencing: An Issue for Rare Mutation Detection
—
Wei-Min Liu, Roche Molecular Systems Inc. ; Julie Chen, UC Berkeley
9:35 AM
Statistical Considerations in Clinical and Analytical Validations for Next Generation Sequencing Based GeneticTests
—
Jincao Wu, Food and Drug Administration ; Meijuan Li, CDRH/FDA
9:50 AM
Inferences from Various Study Designs for Companion Diagnostic Device Evaluation
—
Jeng Mah, Beckman Coulter
10:05 AM
Companion Diagnostic Device Partial Bridging Study in Precision Medicine - Challenges and Methods
—
Yaji Xu, FDA/CDRH
500 * !
Wed, 8/2/2017,
10:30 AM -
12:20 PM
CC-313
Beyond Randomized Studies: Nonrandomized, Single Arm, or Special Studies — Topic Contributed Papers
Section on Medical Devices and Diagnostics
Organizer(s): Shiling Ruan, Novartis, Jie (Jack) Zhou, FDA/CDRH
Chair(s): Ahn Chul, FDA/CDRH
10:35 AM
Why Not Consensus Reading with Multiple Readers for Evaluating a New (Test) Device?
—
Bipasa Biswas, CDRH, FDA
10:55 AM
Confidence Interval Estimate of Success Rate on Correlated Data in a Single Arm Study
—
Kate Wang, Allergan ; Richard Weng, Allergan ; Yijun Sun, Allergan
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
11:35 AM
Biomarker Based Study Design with Multiple Single Arms
—
Shiling Ruan, Novartis
11:55 AM
Design and Analysis of Single Arm Clinical Trials Involving Highly Heterogeneous Subjects
—
Sherry Liu, FDA
12:15 PM
Floor Discussion
624 *
Thu, 8/3/2017,
8:30 AM -
10:20 AM
CC-329
Trial Design and Analysis Issues in Medical Devices — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Alvin Van Orden, FDA/ CDRH
8:35 AM
How Robust Are Your Trial Results? An Applied Comparison of Time-To-Event Missing Data Analyses
—
Joshua Rapkin, Abbott
8:50 AM
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
9:05 AM
Prospective Specification of a Conditional Power Prior for Clinical Trials
—
Tyson Rogers, NAMSA
9:20 AM
Multiple Testing Approaches in Device Clinical Trials
—
Vandana Mukhi, FDA/CDRH ; Heng Li, U. S. FDA
9:35 AM
Statistical Considerations for Studies with a Performance Goal
—
Xu Yan, U.S. Food and Drug Administration ; Heng Li, U. S. FDA ; Yun-Ling Xu, U.S. FDA
9:50 AM
Benefit Risk Assessment in Medical Device Clinical Trials
—
Mourad Atlas, FDA ; Chul Ahn, FDA
10:05 AM
Learning Curve Estimation in Medical Devices and Procedures: Hierarchical Modeling
—
Usha Govindarajulu, SUNY Downstate ; Michael Matheny, Vanderbilt University ; David Goldfarb, Montefiore Medical Center ; Marco Stillo, SUNY Downstate Medical Center ; Frederic Resnic, Lahey Clinic
642 * !
Thu, 8/3/2017,
10:30 AM -
12:20 PM
CC-349
Data-Driven Modeling in Medical and Health Policy Decision Making — Invited Papers
Section on Statistics in Epidemiology , Health Policy Statistics Section , Biometrics Section , ENAR , Section on Medical Devices and Diagnostics
Organizer(s): Chenyang Gu, Harvard Medical School, Liangyuan Hu, Icahn School of Medicine at Mount Sinai
Chair(s): Chenyang Gu, Harvard Medical School
10:35 AM
Leveraging Flexible Modeling Techniques in Data-driven Analytics
—
Liangyuan Hu, Icahn School of Medicine at Mount Sinai ; Madhu Mazumdar, Icahn School of Medicine at Mount Sinai
11:00 AM
Analytic Approaches to Decision Support at the Policy and Patient Level: a Case Study in HIV Treatment Monitoring in Kenya
—
Tao Liu, Brown University, Dept of Biostatistics ; Joseph Hogan, Brown University, Dept of Biostatistics ; Rami Kantor , Brown Univeresity School of Medicine
11:25 AM
Multi-Arm Bayesian Designs for Clinical Trials
—
Lorenzo Trippa, Dana-Farber Cancer Institute, Harvard
11:50 AM
Optimizing Patient Selection for Chemoprevention Through Predictive Modeling
—
Xi Kathy K Zhou, Weill Cornell Medical College
12:15 PM
Floor Discussion
666
Thu, 8/3/2017,
10:30 AM -
12:20 PM
CC-347
Prediction and Calibration — Contributed Papers
Section on Statistics in Epidemiology , Section on Medical Devices and Diagnostics
Chair(s): Shankang Qu, PepsiCo
10:35 AM
Piecewise Mixed Effects Model to Detect Event Associated Changes in Health Trajectories: Pre- and Post-Acute-Bronchitis Growth Trajectories in Children Ages 0-5 Years
—
Md Hossain, Nemours Biomedical Research, A.I. DuPont Children's Hospital ; H Tim Bunnell, Nemours ; Thomas H Shaffer, Nemours
10:50 AM
Early-Life Exposures and Longitudinal Growth Patterns: A Comparison of Statistical Methods
—
Brianna Heggeseth, Williams College
11:05 AM
Model Assessment on Longitudinal Binary Data with Time-Dependent Covariates
—
Tan Li, Florida International University ; Katrina INTERNATIONAL Epnere, Florida International University
11:20 AM
Calibration and Seasonal Adjustment for Matched Case-Control Studies of Vitamin D and Cancer
—
Mitchell Gail , National Cancer Institute, NIH, HHS ; Jincao Wu, Food and Drug Administration ; Molin Wang, Harvard T. H. Chan School of Public Health and Channing Division of Network Medicine ; Shiaw-Shyuan Yaun, Harvard T. H. Chan School of Public Health ; Nancy R. Cook, Harvard T. H. Chan School of Public Health ; A. Heather Eliassen, Harvard T. H. Chan School of Public Health ; Marjorie L McCullough, American Cancer Society ; Kai Yu, National Cancer Institute ; Anne Zeleniuch-Jacquotte, New York University School of Medicine ; Stephanie A. Smith-Warner, Harvard T. H. Chan School of Public Health ; Regina G. Ziegler, National Cancer Institute ; Raymond Carroll, Texas A&M University
11:35 AM
Method Development for the Analysis of Pooled Biomarker Data
—
Abigail Sloan, Harvard T.H. Chan School of Public Health ; Molin Wang, Harvard T. H. Chan School of Public Health and Channing Division of Network Medicine
11:50 AM
Beta Regression for Modeling the ROC as a Function of Continuous Covariates
—
Sarah Stanley, Baylor University ; Jack Tubbs, Baylor University