JSM 2016 Online Program

Sessions Were Renumbered as of May 19.

Legend:
CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

44	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W194a
Trial Design and Analysis Issues in Medical Devices — Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section
Chair(s): Zengri Wang, Medtronic
2:05 PM	Analysis of Matched Data for Noninferiority Trials — Jeremiah Perez, Boston University ; Joseph M. Massaro, Boston University
2:20 PM	A Constancy-Enforced Noninferiority Design of Medical Device Trials with a Binary Endpoint — Ying Yang, FDA/CDRH ; Yunling Xu, FDA/CDRH ; Nelson LU, FDA/CDRH ; Yu Zhao, FDA
2:35 PM	Incorporation of Historical Information in Bayesian Analysis of Crossover Medical Device Clinical Trials — Youssef Toubouti, Johnson & Johnson Vision Care ; Xiwei Chen, Johnson & Johnson Vision Care
2:50 PM	On Weighted Performance Goals in Medical Device Single-Arm Clinical Studies — Nelson LU, FDA/CDRH ; Yunling Xu, FDA/CDRH
3:05 PM	Developing and Validating Visual Assessment Tools for Use in Medical Device Trials — Alvin Van Orden, FDA
3:20 PM	Tests for Interaction in Clinical Studies — Chul Ahn, FDA/CDRH ; Mourad Atlas, FDA/CDRH
3:35 PM	Statistical Study Design Considerations for Medical Device Clinical Studies from an FDA Reviewer's Perspective — Xu Yan, FDA ; Heng Li, FDA ; Vandana Mukhi, FDA

213464	Sun, 7/31/2016, 6:00 PM - 7:00 PM	H-Pullman Boardroom
Section on Medical Devices and Diagnostics Officers Meeting (Closed) — Other Cmte/Business
Section on Medical Devices and Diagnostics
Chair(s): Gene Pennello, FDA/CDRH/OSB/DBS

151 * !	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W183c
Benefit-Risk Evaluation in Medicine — Invited Papers
Section on Medical Devices and Diagnostics , International Chinese Statistical Association , Committee on Applied Statisticians , Section on Risk Analysis
Organizer(s): Martin Ho, FDA/CDRH
Chair(s): Norberto Pantoja-Galicia, FDA/CDRH
10:35 AM	An Overview of Structured Benefit-Risk Analysis — Qi Jiang, Amgen ; Weili He, Merck
11:00 AM	Bayesian Benefit Risk Assessments for Medical Products — Telba Irony, FDA
11:25 AM	Recent Developments in Benefit-Risk Evaluation for Diagnostic Tests — Gene Pennello, FDA/CDRH/OSB/DBS ; Norberto Pantoja-Galicia, FDA/CDRH ; Scott Evans, Harvard
11:50 AM	Discussant: Scott Evans, Harvard
12:10 PM	Floor Discussion

261	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W192a
Diagnostics, Classification, and Prediction — Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Alexander Kaizer, University of Minnesota
2:05 PM	Receiver Operating Characteristic Analysis Under Tree Orderings of Disease Classes — Dan Wang, SUNY Buffalo ; Lili Tian, SUNY Buffalo ; Kristopher Attwood, Roswell Park Cancer Institute
2:20 PM	Using ANOVA/Random-Effects Variance Estimates to Compute a Two-Sample U-Statistic of Order (1,1) Estimate of Variance — Lucas Tcheuko, FDA ; Brandon Gallas, FDA ; Frank Samuelson, FDA
2:50 PM	A Metric for the Optimal Length of a Sequence of Tests for Classification Tasks — Christine Schubert Kabban, Air Force Institute of Technology
3:05 PM	Design and Analysis Considerations for Precision Studies in In-Vivo Diagnostic Test Studies — Changhong Song, FDA
3:20 PM	Generalized Linear Mixed Models for Analysis of Cross-Correlated Binary Response in Multireader Studies of Diagnostic Accuracy — Yuvika Paliwal ; Andriy Bandos, University of Pittsburgh
3:35 PM	Localized Semiparametric Prediction: A Precision Medicine Approach in a Trauma Patient Population — Sara E. Moore, University of California at Berkeley ; Alan E. Hubbard, University of California at Berkeley ; Mitchell J. Cohen, University of California at San Francisco

265	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-Hall F1 West
Contributed Poster Presentations: Section on Medical Devices and Diagnostics — Contributed Poster Presentations
Section on Medical Devices and Diagnostics
Chair(s): Genevera Allen, Rice University
62:	Sufficient Markov Decision Processes — Longshaokan Wang, North Carolina State University
63:	Analysis of Pleural Effusion After Allogeneic Hematopoietic Stem Cell Transplant Using Multistate Models — Joohyoung Lee, Karmanos Cancer Institute ; Dipenkumar Modi, Wayne State University ; Hyejeong Jang, Karmanos Cancer Institute ; Joseph Uberti, Wayne State University ; Seongho Kim, Karmanos Cancer Institute
64:	Accelerometer Wear and Non-Wear Classification Using an Ensemble of Unsupervised Predictors — Madalina Fiterau Brostean, Stanford University ; Manisha Desai, Stanford University ; Jennifer Hicks, Stanford University ; Thomas Robinson, Stanford University
65:	Noninferiority Studies with Multiple Reference Treatments and Heterogeneous Variances — Li-Ching Huang ; Miin-Jye Wen, National Cheng Kung University ; Yu Shyr, Vanderbilt University
66:	Spatio-Temporal Regression for Longitudinally Acquired MRI Data — Arnab Hazra, North Carolina State University ; Brian J. Reich, North Carolina State University ; Ana-Maria Staicu, North Carolina State University
67:	Modeling Passively Collected Biomedical Data — Moumita Chakraborty ; Eric Laber, North Carolina State University ; Ana-Maria Staicu, North Carolina State University
68:	Meta-Analysis of Predictive Values of Biomarkers — Mun Sang Yue, Brown University ; Constantine Gatsonis, Brown University

213641	Mon, 8/1/2016, 6:00 PM - 7:00 PM	H-Boulevard A
Section on Medical Devices and Diagnostics Business Meeting — Other Cmte/Business
Section on Medical Devices and Diagnostics
Chair(s): Gene Pennello, FDA/CDRH/OSB/DBS

348 * !	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W192a
Statistical Methodology to Address Challenges in Medical Diagnostic Devices — Topic Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Jeng Mah, Beckman Coulter Inc.
Chair(s): Alvin Van Orden, FDA
10:35 AM	A Bayesian Adaptive Clinical Trial Design: Diagnostic Accuracy of an Olfactory Diagnostic Test for Traumatic Brain Injury in Combat Soldiers — Benjamin Saville, Berry Consultants
10:55 AM	The Effects on Diagnostic Accuracy of Repeated Testing and Decision Rule Design — Jeng Mah, Beckman Coulter Inc.
11:15 AM	Group Sequential Method for Correlated ROC Curves — Xuan Ye, FDA ; Larry Tang, George Mason University
11:35 AM	Method Comparison Study for Diagnostic Devices with Dichotomous Output — Bipasa Biswas, FDA/CDRH
11:55 AM	Floor Discussion

CE_30C	Tue, 8/2/2016, 1:00 PM - 5:00 PM	CC-W475b
Designing Observational Comparative Studies Using Propensity Score Methodology in Regulatory Settings (ADDED FEE) — Professional Development Continuing Education Course
ASA , Section on Medical Devices and Diagnostics
Instructor(s): Donald B. Rubin, Harvard, Lilly Yue, FDA/CDRH/OSB
1:00 PM	Designing Observational Comparative Studies Using Propensity Score Methodology in Regulatory Settings (ADDED FEE) — Donald B. Rubin, Harvard ; Lilly Yue, FDA/CDRH/OSB

474 * !	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W180
Enrichment Strategies in Clinical Development — Invited Papers
Section on Medical Devices and Diagnostics , ENAR
Organizer(s): Hong Tian, Janssen R&D
Chair(s): Sudhakar Rao, Janssen R&D
8:35 AM	Estimation After Adaptive Population Enrichment Design — Vlad Dragalin, Janssen
9:00 AM	Adaptive Multi-Arm Multi-Stage Group Sequential Designs — Cyrus Mehta, Cytel ; Pranab Ghosh, Cytel
9:25 AM	Adaptive Enrichment Trials for Biomarker-Guided Treatments — Noah Simon, University of Washington ; Richard Macey Simon, National Cancer Institute
9:50 AM	Discussant: Richard Macey Simon, National Cancer Institute
10:10 AM	Floor Discussion

623	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W187c
Statistical Methods in Medical Devices and Diagnostics — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Natalia Gouskova, Harvard T.H. Chan School of Public Health
2:05 PM	Comparison of Propensity Score Methods for Estimating Average Treatment Effects with Ordinal Treatment — Juan Ding, Vanderbilt University ; Chang Yu, Vanderbilt University ; Hui Nian, Vanderbilt University ; Tebeb Gebretsadik, Vanderbilt University ; Tan Ding, Vanderbilt University ; William Dupont, Vanderbilt University ; Tina Hartert, Vanderbilt University ; Pingsheng Wu, Vanderbilt University
2:20 PM	A Statistical Clinical Decision Support Tool for Determining Thresholds in Remote Monitoring Using Predictive Analytics — Celeste Fralick, Intel Corporation
2:35 PM	Hierarchical Classification Models for Functional Data — Abhirup Mallik ; Snigdhansu Chatterjee, University of Minnesota - Twin Cities
2:50 PM	Nonstationary and Spectral Analysis of Balance Dynamics in Patients with Parkinson's Disease — Tanujit Dey, Cleveland Clinic ; Wojbor Woyczynski, Case Western Reserve University ; Sarah Ozinga, Cleveland Clinic ; Jay Alberts, Cleveland Clinic
3:05 PM	Statistical Issues in Evaluating Hemostasis State of a Blood Sample — Kyungsook Kim, FDA
3:20 PM	Effect of Skewed and Nonparametric Link Functions for Rater-Item Binary Data — Xiaoyan Lin, University of South Carolina ; Don Edwards, University of South Carolina
3:35 PM	Assessment of Multiple Aesthetic Photonumeric Scales: A Novel Algorithm for Randomly Selecting Populations with Minimal Imbalance Across Scale Grades — Shraddha Mehta, Allergan ; Rowena Fronda Bastero, Allergan ; Yijun Sun, Allergan ; Diane Murphy, Allergan ; Ray Zhu, Allergan ; Bhushan Hardas, Allergan

646 *	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W187c
Multiplicity in Diagnostic Device Development and Validation — Topic Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , Section on Statistics in Imaging
Organizer(s): Gene Pennello, FDA/CDRH/OSB/DBS
Chair(s): Alicia Y. Toledano, Biostatistics Consulting, LLC
8:35 AM	Identifying Optimal Approaches to Early Termination in Two-Stage Biomarker Validation Studies — Alexander Kaizer, University of Minnesota ; Joseph S. Koopmeiners, University of Minnesota
8:55 AM	Statistical Considerations in Evaluating Radiological Imaging Devices in FDA/CDRH — Qin Li, FDA/CDRH
9:15 AM	Different Success Criteria in the Performance Evaluation of Diagnostic Devices — Norberto Pantoja-Galicia, FDA/CDRH ; Gene Pennello, FDA/CDRH/OSB/DBS
9:35 AM	Creating a Biomarker Signature for a Companion Diagnostic Using Bootstrapping and Aggregating Thresholds from Tree-Based Models — Raj Chandran
9:55 AM	Multiple Endpoint Evaluation in Diagnostic Medical Imaging: Analyses, Labeling, and Claims — Camille Vidal, GE Healthcare
10:15 AM	Floor Discussion

JSM 2016 Online Program

Activity Details

ASA Meetings Department

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