JSM 2017 Online Program

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

214780	Sun, 7/30/2017, 6:00 PM - 7:00 PM	CC-305
Section on Medical Devices and Diagnostics Officers Meeting — Other Cmte/Business
Section on Medical Devices and Diagnostics
Chair(s): Theodore Lystig, Medtronic, Inc.

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.

214781	Mon, 7/31/2017, 6:00 PM - 7:00 PM	CC-312
Section on Medical Devices and Diagnostics Business Meeting — Other Cmte/Business
Section on Medical Devices and Diagnostics
Chair(s): Theodore Lystig, Medtronic, 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

367	Tue, 8/1/2017, 12:30 PM - 1:50 PM	CC-Ballroom II
Section on Medical Devices and Diagnostics P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Section on Medical Devices and Diagnostics
Organizer(s): Alicia Toledano, Biostatistics Consulting, LLC
TL19:	Design Specifications of Performance for an Analytical Laboratory Method — Beimar Iriarte, Abbott Laboratories

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

539	Wed, 8/2/2017, 12:30 PM - 1:50 PM	CC-Ballroom II
Section on Medical Devices and Diagnostics P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Section on Medical Devices and Diagnostics
Organizer(s): Alicia Toledano, Biostatistics Consulting, LLC
WL18:	Considerations in Transitioning from Proprietary to Non-Proprietary Statistical Software to Support Regulatory Submissions — Theodore Lystig, Medtronic, Inc.

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

JSM 2017 Online Program

Activity Details

ASA Meetings Department

Share