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Activity Details


15 * !
Mon, 8/3/2020, 10:00 AM - 11:50 AM Virtual
Incorporating Knowledge from Previous Clinical Trials into the Design of New Trials — Invited Papers
Biopharmaceutical Section, Section on Medical Devices and Diagnostics
Organizer(s): Steven J Schwager, Cornell University
Chair(s): Steven J Schwager, Cornell University
10:05 AM Borrowing from Historical Data in Cancer Drug Development: A Cautionary Tale and Experience with Bayesian Adaptive Platform Designs
James Normington, University of Minnesota; Connor Jo Lewis, Securian Financial Group, Inc.; Somnath Sarkar, Flatiron, Inc.; Jiawen Zhu, Roche-Genentech; Federico Mattiello, F. Hoffman-La Roche, Inc.
10:30 AM Statistical Methods and Process for Historical Data Borrowing in Clinical Trials
Lanju zhang, AbbVie Inc; Zailong Wang, AbbVie Inc; Ivan Chan, AbbVie Inc
10:55 AM Bayesian Synthetic Control Approaches in Pediatric Drug Development: A Case Study in Acute Lymphoblastic Leukemia
Antara Majumdar, Medidata Solutions; Jingjing Ye, FDA; Rebecca Rothwell, FDA; Corinne Ahlberg, Acorn AI by Medidata, a Dassault Systèmes company
11:20 AM Discussant: Pallavi Mishra-Kalyani, US FDA
11:45 AM Floor Discussion
 
 

34 * !
Mon, 8/3/2020, 10:00 AM - 11:50 AM Virtual
Current and Future Challenges in Diagnostic Device Evaluation — Topic Contributed Papers
Section on Medical Devices and Diagnostics
Organizer(s): Bipasa Biswas, Center for Devices and Radiological Health, FDA; Manasi Sheth, Food and Drug Administration
Chair(s): Chava Zibman, Food and Drug Administration
10:05 AM Proper and Improper Summary Measures of Classification Performance
Andriy Bandos, University of Pittsburgh
10:25 AM Comparative Evaluations of Diagnostic Tests in Studies with Extreme Verification Bias
Gene Pennello, Food and Drug Administration; Qin Li, Food and Drug Administration
10:45 AM Statistical Considerations in Artificial Intelligence Related Diagnostic Devices Presentation
Manasi Sheth, Food and Drug Administration; Daniel Erchul, Food and Drug Administration
11:05 AM Artificial Intelligence for Risk Prediction and/or Stratification
Bipasa Biswas, Center for Devices and Radiological Health, FDA
11:25 AM Designing Studies of Tests for Biomarkers Using Banked Specimens
Alicia Toledano, Biostatistics Consulting, LLC
11:45 AM Floor Discussion
 
 

54
Mon, 8/3/2020, 10:00 AM - 2:00 PM Virtual
Methods and Modeling for Medical Device and Clinical Studies — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Tracy Bergemann, Medtronic
Dynamic ICU Predictor Model of Pediatric in Hospital Mortality
James Bost, Children's National Hospital; Anita Patel, Children's National Hospital; Eduardo Antonio Trujillo Rivera, George Washington University; Qing Zeng, George Washington University; Murray M Pollack, Children's National Hospital
Multivariate Treatment Effects in Contaminated Randomized Trials
Zi Ye
Additive Functional Cox Model Presentation
Erjia Cui, Johns Hopkins University; Andrew Leroux, Johns Hopkins University; Ciprian Crainiceanu , Johns Hopkins University
Heart Transplantation: An In-Depth Survival Analysis
Gang Xu, University of Miami; Eileen Michelle Hsich, Cleveland Clinic; Eugene Blackstone, Cleveland Clinic; Lucy Thuita, Cleveland Clinic; Dennis McNamara, University of Pittsburgh Medical Center; Joseph Rogers, Duke University; Clyde Yancy, Northwestern University Medical Center; Lee Goldberg, Hospital of the University of Pennsylvania; Maryam Valapour, Cleveland Clinic; Hemant Ishwaran, University of Miami
Use of Intermediate Predictive and Surrogate Endpoints in Medical Device Trials
Manuela Buzoianu, FDA
Pain Assessment Using Errors-In-Variables Regression
Bin Wang, Food and Drug Administration CDRH
 
 

186
Tue, 8/4/2020, 10:00 AM - 2:00 PM Virtual
Biomarker and Diagnostic Test Evaluation — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Joshua Xu, FDA NCTR
Evaluation of Polytomous Diagnostic Tests
Jeng Mah, Beckman Coulter
Statistical Considerations for Evaluating MRMC Studies with Qualitative Endpoints
Changhong Song, FDA
A Statistical Evaluation of Alternative Techniques for Kinetic Analysis of Multiple Injection Dynamic PET Scans
Fengyun Gu, University College Cork; Finbarr O'Sullivan, University College Cork; Qi Wu, University College Cork; Mark Muzi, University of Washington ; David Mankoff, University of Pennsylvania
Statistical Inference for the Difference of Two Youden Indices Obtained from Correlated Biomarkers
Leonidas Bantis, University of Kansas Medical Center; Christos Nakas, University of Thessaly; Benjamin Reiser, University of Haifa
Bayesian Analysis of Dependent Agreement Measures
Ananda Sen, University of Michigan Biostatistics; Wen Ye, University of Michigan; Pin Li, University of Michigan
 
 

225
Tue, 8/4/2020, 10:00 AM - 2:00 PM Virtual
Contributed Poster Presentations: Section on Medical Devices and Diagnostics — Contributed Poster Presentations
Section on Medical Devices and Diagnostics
2: Maintaining Proper Type 1 Error Control in Single Arm Studies of Time-to-Event Data
Martiniano Flores, Edwards Lifesciences
3: Overall Agreement for Multiple Raters with Replicated Measurements
Tongrong Wang
6: Novel Insights for Measuring Interrater Agreement: Exploring Fundamental Principles
Katelyn McKenzie, University of Kansas Medical Center; Jonathan Mahnken, Department of Biostatistics and Data Science, The University of Kansas Medical Center
7: Analyzing Accelerometer Data with Probability Activity Curves Graphs
Margaret Banker, University of Michigan
 
 

247 *
Tue, 8/4/2020, 1:00 PM - 2:50 PM Virtual
Wearable/Implantable Device Data in Clinical Trials — Invited Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section
Organizer(s): Tracy Bergemann, Medtronic
Chair(s): Tyson Rogers, NAMSA
1:05 PM Digital Health Technology: Use in Clinical Investigations to Evaluate Clinical Benefit in Patients
Ebony Dashiell-Aje, BioMarin Pharmaceutical Inc.
1:25 PM Statistical Challenges in Incorporating Data from Mobile Technology into Clinical Trials
Manisha Desai, Stanford University
1:45 PM Normalization of Minute-Level Activity Counts from Chest- and Wrist-Worn Accelerometers: An Example of Actiheart, Actiwatch, and Actigraph
Vadim Zipunnikov, Johns Hopkins University, Bloomberg School of Public Health; Jiawei Bai, Johns Hopkins Bloomberg School of Public Health
2:05 PM Use of Accelerometer Data to Evaluate Physical Activity as a Surrogate Endpoint in Heart Failure Clinical Trials Presentation
Tracy Bergemann, Medtronic
2:25 PM Data-Driven Chronotype Discovery Using Functional Data Methods
Jeff Goldsmith, Columbia University Mailman School of Public Health
2:45 PM Floor Discussion
 
 

320
Wed, 8/5/2020, 10:00 AM - 2:00 PM Virtual
Methods Tailored to Unique Data and Trial Features — Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Biometrics Section
Chair(s): James Bost, Children's National Hospital
Efficacy Lead-In Phase 2 Single-Arm Trial Designs
Seongho Kim, Wayne State University; Weng-Kee Wong, UCLA; Nithya Ramnath, Department of Medicine, University of Michigan; Manohar Ratnam, Department of Oncology, Wayne State University
Order Constrained ROC Regression with Application to Facial Recognition Presentation
Xiaochen Zhu, George Mason University; Martin Slawski, George Mason Univ; Larry Tang, University of Central Florida; Jonathon Phillips, National Institute of Standards and Technology
The Impact of Misclassification on Covariate-Adaptive Randomized Clinical Trials
Tong Wang, Texas A&M University; Wei Ma, Institute of Statistics and Big Data, Renmin University of China
Median Regression Models for Clustered, Interval-Censored Survival Data: An Application to Prostate Surgery Study
Piyali Basak, Florida State University; Stuart Lipsitz, Brigham and Women's Hospital; Debajyoti Sinha, Florida State University
Inference with Joint Models Under Mis-specified Random Effects Distributions
Abdus Sattar; Sanjoy K. Sinha, Carleton University
Gumbel Regression Models for Longitudinal Continuous Biomarker Outcome Subject to Measurement Error
Noorie Hyun, Medical College of Wisconsin; David Couper, University of North Carolina at Chapel Hill; Donglin Zeng, University of North Carolina at Chapel Hill
A Regression Approach to Estimating the Discrete Diagnostic Likelihood Ratio for Nontraditional Biomarkers
Hanna Lindner, University of Pennsylvania; Warren Bilker, University of Pennsylvania; Phyllis Gimotty, University of Pennsylvania
 
 

384 * !
Wed, 8/5/2020, 1:00 PM - 2:50 PM Virtual
Recent Statistical Advances in Diagnostic Medicine — Invited Papers
Section on Medical Devices and Diagnostics, Biometrics Section, ENAR
Organizer(s): Lu Mao, University of Wisconsin-Madison
Chair(s): Yi Chen, University of Wisconsin-Madison
1:05 PM Statistical Inference on the Accuracy of Computer-Aided Diagnosis (CAD) Using Artificial Intelligence-Based Systems
Xiao-Hua Zhou, Peking University
1:30 PM Early Diagnosis of Neurological Disease Using Peak Degeneration Ages of Multiple Biomarkers
Fei Gao, Fred Hutchinson Cancer Research Center; Yuanjia Wang, Columbia University; Donglin Zeng, University of North Carolina at Chapel Hill
1:55 PM Integrating Multiple-Domain Rules for Disease Classification
Christine Mauro, Columbia University; Katherine Shear, Columbia University; Yuanjia Wang, Columbia University
2:20 PM Nonparametric Optimal Rules for Combining Multiple Quantitative Imaging Biomarkers
Lu Mao, University of Wisconsin-Madison
2:45 PM Floor Discussion
 
 

409
Wed, 8/5/2020, 1:00 PM - 2:50 PM Virtual
Complex Innovative Approaches in Emerging Neurodegenerative / Neuroimaging Drug Developments — Topic Contributed Papers
Biopharmaceutical Section, Section on Medical Devices and Diagnostics, Section on Statistics in Imaging
Organizer(s): Tristan Massie, FDA
Chair(s): Sue-Jane Wang, FDA
1:05 PM A ROC Surface Methodology in Diagnosing Early Stage Neurodegenerative Diseases for Early Interventions
Chengjie Xiong, Washington University in St Louis; Jingqin Luo, Washington University in St. Louis
1:25 PM Alternatives to MMRM for Preclinical Alzheimer’s Clinical Trials Presentation
Michael C Donohue, University of Southern California; Gopalan Sethuraman, University of Southern California; Oliver Langford, University of Southern California; Wenyi Lin, University of California, San Diego; Philip S Insel, Lund University; Wesley Thompson, University of California, San Diego; Rema C Raman, University of Southern California; Reisa Sperling, Harvard Medical School; Paul S Aisen, University of Southern California
1:45 PM Comparative Performance of Some Testing Approaches in Two-Arm Studies with Count Data Potentially Highly Skewed
Sue-Jane Wang, FDA; Zhipeng Huang, U.S. Food and Drug Administration (Intern); Hai Zhu, The University of Texas Health Science Center at Houston
2:05 PM Statistical Issues and Challenges Seen in Drug Development for Neurodegenerative Diseases
Tristan Massie, FDA
2:25 PM Floor Discussion
 
 

410 *
Wed, 8/5/2020, 1:00 PM - 2:50 PM Virtual
Benefit-Risk Methods for Medical Devices and Diagnostics — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Biometrics Section
Organizer(s): Tyson Rogers, NAMSA
Chair(s): Richard Kotz, NAMSA
1:05 PM Using Outcomes to Analyze Patients Rather Than Patients to Analyze Outcomes
Scott Evans
1:25 PM Using Patient-Centered Utility-Weighted Outcomes in a Bayesian Adaptive Enrichment Trial
Kert Viele, Berry Consultants
1:45 PM Classification Accuracy Goals for Diagnostic Tests Based on Risk Stratification Presentation
Qin Li, Food and Drug Administration; Gene Pennello, Food and Drug Administration; Dandan Xu, Food and Drug Administration
2:05 PM Discussant: Telba Irony, CBER – FDA
2:25 PM Discussant: Gregory Campbell, GCStat Consulting
2:45 PM Floor Discussion
 
 

435 * !
Thu, 8/6/2020, 10:00 AM - 11:50 AM Virtual
Making the Most of Wearable Device Data: Functional Data Approaches — Invited Papers
Biometrics Section, Section on Medical Devices and Diagnostics, Section on Nonparametric Statistics
Organizer(s): Andrew Leroux, Johns Hopkins University
Chair(s): Andrew Leroux, Johns Hopkins University
10:05 AM Functional Regression with Survey Weights and Its Application to NHANES 2003-2006
Lucia Tabacu, Old Dominion University ; Ekaterina Smirnova, Virginia Commonwealth University ; Andrew Leroux, Johns Hopkins University; Ciprian Crainiceanu , Johns Hopkins University
10:40 AM Predicting GI Bleeds Using Wearable Device Data
Julia Wrobel, Colorado School of Public Health
11:15 AM Floor Discussion
 
 

463 *
Thu, 8/6/2020, 10:00 AM - 2:00 PM Virtual
Topics in Biostatistics — Contributed Papers
Section on Medical Devices and Diagnostics, Royal Statistical Society, ENAR
Chair(s): Tyson Rogers, NAMSA
Does Concomitant Medication Tapering Impact Interim Analysis Projection
Grace Liu, Johnson & Johnson; Karen Xia, Johnson & Johnson
The Landscape of Cancer Communication in India
Jaya Satagopan, Rutgers University School of Public Health
A Scanning-Based Inverse Propensity Weighting for Nonrandom Missing Data with Continuous Instrumental Variables
David Todem, Michigan State University; Arkaprabha Ganguli , Department of Statistics and Probability, MSU
Applications of Design of Experiments to Develop a Robust Assay for Replacing the Rabbit Blood Sugar Bioidentity Test of Insulin Glargine
Monisha Dey, Merck & Co., Inc; Junming Yie, Merck & Co., Inc