77
Mon, 8/3/2020,
10:00 AM -
2:00 PM
Virtual
Contributed Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations
Biopharmaceutical Section
1:
The Framework of a Three-Stage Design for Allergen Immunotherapy Trials
Xinyu Tang, FDA ; Lihan Yan, Vaccine Evaluation Branch-CBER-FDA
2:
Using Digital Data in an Early Phase Clinical Trial to Quantitate Baroreceptor Sensitivity Variability
Anwesha Mukherjee, Merck & Co Inc ; Geoffrey Walford, Merck& Co., Inc; Leticia Arrington, Merck & Co, Inc; Adrienne DiBenedetto, Merck & Co., Inc; Ruben Declercq, Merck & Co, Inc; Inge DeLepeleire, Merck & Co., Inc; Helia Norouzizadeh, Merck & Co., Inc
3:
Statistical Impact of Delayed Treatment Effect: A Simulation Study
Yuanbo Song, Novartis Pharmaceuticals Corp ; Bharani Bharani-Dharan, Novartis Oncology
4:
The Role of Design and Analysis Methods on Go/No-Go Decision in Proof-of-Concept Trials
Macaulay Okwuokenye
5:
Accounting for Suboptimal Treatment Adherence When Estimating Heterogenous Treatment Effects from Observational Data
Gabrielle Simoneau, Biogen Canada ; Fabio Pellegrini, Biogen International GmbH; Carl de Moor, Biogen Inc; Lu Tian, Department of Biomedical Data Sciences, Stanford University
6:
Regional Efficacy Evaluation in Multi-Regional Clinical Trials Using a Discounting Factor Weighted Z Test
Jingwei Wu, College pf Public Health, Temple University; XUANXUAN YU, Dept of Epidemiology & Biostatistics, School of Public Health, University of South Carolina ; Jianling Bai, School of Public Health, Nanjing Medical University; Hao Yu, School of Public Health, Nanjing Medical University
7:
Multiplicity in Vaccine Clinical Studies – A Case Study with Gate-Keeping Testing Strategy
Huajun Wang, GSK Vaccines ; Ellen Ypma, GSK Vaccines; Uwe Nicolay, GSK Vaccines
8:
Interim Analysis in Double Blinded Vaccine Trials Using the Semiparametric Density Ratio Model
Jing Qin, National Institute of Allergy and Infectious Diseases
9:
TITE-ToBI: The Time-to-Event Toxicity Burden Interval Design to Accelerate Phase I Trials
Meizi Liu, University of Chicago ; Yuan Ji, University of Chicago
10:
Revisiting Prior Selection for Scale Parameters in Hierarchical Models
Qianqiu Li, Janssen Research & Development ; Jyh-Ming Shoung, Janssen Research & Development; Bill Pikounis, Janssen Research & Development
11:
Bioequivalence Study Design for Multiplicity
Michelle Quinlan, Novartis Oncology ; Ekkehard Glimm, Novartis; Bharani Bharani-Dharan, Novartis Oncology
12:
Bayesian Topic Modeling of Adverse Event Data
Andrew Bean, Novartis ; Thibaud Coroller, Novartis
13:
Statistical Analysis Considerations for Clinical Outcome Assessments Based Endpoints
Chul Ahn, FDA-CDRH
14:
Randomization and Randomization Tests for Multi-Armed Randomized Clinical Trials
Yanying Wang
15:
A Multiomics Statistical Framework for Drug Repositioning
Zhaolong Yu, Yale University ; Kexuan Liang, Peking University; Hongyu Zhao, Yale University
16:
Imputation Strategies Within the Estimand Framework to Evaluate the Overall Likelihood of Patient Improvement in Longitudinal Trails
Lysbeth Floden, Clinical Outcomes Solutions
17:
Cost-Efficient Two Stage Sequential Multiple Assignment Randomized Trial Designs
Grecio Sandoval, The George Washington University ; Ionut Bebu, The George Washington University; John Lachin, The George Washington University
18:
Evaluation of Safety Signals Using Association Rule Mining (ARM)
Jagannath Ghosh, Novartis Pharmaceutical ; Tania Roy, Novartis Pharmaceutical
19:
Evaluation of Improper Analysis of Clinical Trials with Prognostic Factor Not Pre-Specified in Stratified Randomization
Shuyan Wan, Merck ; Pingye Zhang, Merck & Co, Inc; Christine Gause, Merck & Co, Inc
21:
Estimation of Discrete Survival Function Through Modeling Diagnostic Accuracy for Mismeasured Outcome Data
Hee-Koung Joeng, MERCK
22:
Dismantling the Fragility Index: A Demonstration of Statistical Reasoning
Gail Potter, The EMMES Corporation
23:
ATCV: A Shiny Application for Safety Tables Review
Lie Li, Merck & Co., Inc. ; Yiwen Luo, Merck & Co., Inc.; Clare Bai, Merck & Co., Inc.
24:
Development of MSD Multiplex Antigenicity Assay
Yongwei Liu, Sanofi Pasteur ; Lingyi Zheng, Sanofi; Jason Szeto, Immunology Platform, Sanofi Pasteur; Melinda Donovan, Immunology Platform, Sanofi Pasteur; Tricia Chen, Immunology Platform, Sanofi Pasteur
25:
Bayesian Prior Choice in Clinical Trials with Binary Responses Using Historical Data
Yonggang Zhao, I-Mab Biopharma ; Qianqiu Li, Janssen Research & Development
26:
Evaluation of Dependency of Multiple Events
Dateng Li
27:
Just in Time, on the Job Statistics Training for Biologics Process Characterization
Melissa Matzke, Merck & Co., Inc. ; Seth Clark, Merck & Co., Inc.; Richard K. Burdick, Burdick Statistical Consulting, LLC; David Christopher, Merck & Co., Inc.
28:
Implementations and Interim Monitoring for Two-Stage Phase II/III Adaptive Designs with a Case Example
Aijun Gao, Covance ; Lingyun Liu, Cytel
29:
On the Use of the Bootstrap to Test Functions of Correlated Variances in Pre-Post Clinical Trials
Navneet Hakhu, University of California, Irvine ; Dan Gillen, University of California, Irvine
30:
AUTOMATING the ORGANIZATION and PROCESSING of BIOASSAY DATA with the R PACKAGE and R SHINY APP AXL
JENNIFER NGUYEN, Merck ; TOM STEINMETZ, Merck
31:
Curtailed Binomial Sampling Design for Clinical Trials with Two Dependent Endpoints
Chishu Yin, Syracuse University ; Pinyuen Chen, Syracuse University
32:
Bayesian Data Envelopment Analysis for Assessing Drug Benefit-Risk
Guangyi Gao ; Jo A. Wick, University of Kansas Medical Center; Byron J Gajewski, KUMC
33:
A Bayesian Adaptive Phase I/II Clinical Trial Design with Late-Onset Competing Risk Outcomes
YIFEI ZHANG ; YONG ZANG, INDIANA UNIVERSITY
35:
Prediction of Long Term Joint Damage in Placebo Patients with Active Psoriatic Arthritis
Yan Liu, Johnson and Johnson ; Prasheen Agarwal, Johnson and Johnson; Xiwu Lin, Janssen Research and Development, LLC; Bei Zhou, Johnson and Johnson
36:
The Use of Subgroup Meta-Analysis to Support Decision Making of Prescription Label Change
Mehreteab Aregay, Novartis Pharmaceuticals Corporation ; Baldur Magnusson, Novartis Pharmaceuticals Corporation; Gregory Ligozio, Novartis Pharmaceuticals Corporation
37:
Preparation and Qualification of an Internal Rabies Reference Standard for RFFIT: From Present to Future
Mohammad Rahman, Sanofi ; Lingyi Zheng, Sanofi
38:
Using Bootstrap to Verify Normal Assumptions in Statistical Inference for Treatment Difference
Ruji Yao, Merck ; Amarjot Kaur, Merck & Co., Inc; Qing Li, Merck Research Labs; Anjela Tzontcheva, Merck & Co., Inc
39:
Evaluations of Methods for Missing Data Imputation Under Missing Not at Random
Weining Robieson, AbbVie ; Mandy Jin, AbbVie Inc.
40:
On the No Free Lunch and Logistic Regression in Healthcare Prediction Problems
Xuan Zhou, Merck Research Lab ; Thomas Jemielita, Merck & Co., Inc; Jie Chen, Merck & Co., Inc.; Xin Chen, Merck Co. & Inc; Gail Fernandes, Merck Co. & Inc; Zifang Guo, Merck Co. & Inc; Zhiwen Liu, Merck Co. & Inc; Richard Baumgartner, Merck
41:
Evaluation of Type I Error Control for Testing Clinical Endpoint with Pre-Testing Surrogate Endpoint
Hsiao-Hui Tsou, National Health Research Institutes ; Yu-Chieh Cheng, National Health Research Institutes; Hsiao-Yu Wu, National Health Research Institutes; Ya-Ting Hsu, National Health Research Institutes; Fang-Jing Lee, National Health Research Institutes; James Hung, Center for Drug Evaluation and Research, FDA
43:
Yet Another Randomization System
Dennis Sweitzer
44:
Quantitative Determination of Threshold in Clinical Outcome Assessments (COA) for a Clinically Meaningful Change
Wenting Cheng, Biogen ; Zijuan Chen, Texas A&M University; Kun Chen, Biogen; Li Zhu, Biogen; Chunlei Ke, Biogen
46:
One- and Two-Sided Hypothesis Tests for a Single Proportion with Clustered Binary Data: Derivation, Type I Error, and Power
Meghan I Short, UT Health San Antonio ; Howard Cabral, Boston University; Janice M Weinberg, Boston University; Michael P LaValley, Boston University; Gina Peloso, Boston University; Joseph M Massaro, Boston University
47:
Modified Factorial Design
Li Yu, Merck & Co., Inc. ; Shu-Chih Su, Merck & Co., Inc.
48:
Utilizing Historical Data in Bayesian Interval Dose-Escalation Designs
Frank Shen
49:
The Effect of Unobserved Covariate in Statistical Inference Under Covariate-Adaptive Randomized Experiment
Yang Liu, George Washington University ; feifang Hu, George Washington University
50:
Impact of Competing Risk on Win Ratio Analysis for Composite Time-to-Event Endpoint
Ran Liao, Eli Lilly and Company ; Bochao Jia; Margaret Gamalo-Siebers, Eli Lilly & Co; Guanglei Yu, Eli Lilly and Company; Sujatro Chakladar, Eli Lilly and Company
51:
Bayesian Design of Clinical Trials for Joint Models of Recurrent Event with a Terminating Event
Jiawei Xu, UNC Chapel Hill ; Matthew A. Psioda, University of North Carolina; Joseph G. Ibrahim, University of North Carolina at Chapel Hill