This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

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Keyword Search Criteria: clinical trial returned 158 record(s)
Sunday, 08/01/2010
Follow-Up of Subjects in Event Rates for Periodic Safety Monitoring Reports in Open Enrollment Clinical Trials
Maria Carola Alfaro, Boston Scientific Corporation
4:05 PM

A Novel Semiparametric Ratio Estimator: A Key to Predicting Long-Term Weight Loss in Obesity
Deborah Weissman-Miller, Dwbus & Assoc. Inc.
4:05 PM

Bayesian Adaptive Designs for Dose Escalation Studies
Anna Elizabeth McGlothlin, Eli Lilly and Company
4:05 PM

Inference on Treatment Effect Under a Density Ratio Model and Random Censoring
Shan Jiang, Queen's University; Dongsheng Tu, Queen's University
4:20 PM

An Evaluation of a Simon 2-Stage Phase II Clinical Trial Design Incorporating Continuous Toxicity Monitoring
Herman Ray, University of Louisville; Shesh Rai, University of Louisville
4:20 PM

Issues of Missing Data in Orthopedic Implant Clinical Trials: A Regulatory Reviewer's Perspective
Jianxiong Chu, FDA
4:25 PM

Exact Two-Stage Designs for Phase II Clinical Trials with Rank-Based Endpoints
Gregory E. Wilding, State University of New York at Buffalo; Guogen Shan, State University of New York at Buffalo; Alan Hutson, State University of New York at Buffalo
4:35 PM

Interval-Censored Time-to-Event Data in Clinical Trials: Analyzing and Designing
Xing Sun, Merck & Co., Inc.; Cong Chen, Merck & Co., Inc.
4:50 PM

A Bayesian Dose-Finding Design Adapting to Efficacy and Tolerability Response
S. Krishna Padmanabhan, Pfizer Inc.; Scott Berry, Berry Consultants, LLC; Vladimir Dragalin, Pfizer Inc.; Michael Krams, Pfizer Inc.
5:05 PM

Assessing the Causal Effect of Treatment Dosages in the Presence of Self-Selection
Xin Gao, University of Michigan; Michael R. Elliott, University of Michigan
5:05 PM

Monday, 08/02/2010
Establishing Sample Size in Clinical Trials Having Multiple Hypotheses
Alan Barry Davis, Pharmanet Development Group, Inc.; Mary M. Poole, Pharmanet Development Group, Inc.; Young Kim, Pharmanet Development Group, Inc.

Development of Imaging Biomarkers for Clinical Trials: Applications in Glioblastoma Multiforme
Hyun (Grace) Kim, University of California, Los Angeles; Jing Huo, University of California, Los Angeles; Matt Brown, University of California, Los Angeles; Jonathan Goldin, University of California, Los Angeles

Harmonic Regression Analysis of Periodic Time Series Data from Clinical Trials
Michael T. Gaffney , Pfizer Inc.; Martin O. Carlsson, Pfizer Inc.; Kelly H. Zou, Pfizer Inc.

Development of Imaging Biomarkers for Clinical Trials: Applications in Rheumatoid Arthritis
Grace S. Park, Amgen Inc.

Definition of a Responder in Clinical Trials for Alcohol Dependence
Yun-Fei Chen, Eli Lilly and Company ; Xiwen Ma, University of Wisconsin-Madison

A Simulation Study to Evaluate Dose-Response in Dose-Titration Clinical Trials: A Dynamic Linear Mixed Effect (DLME) Modeling Approach
Xu Steven Xu, Johnson & Johnson; Min Yuan, Fudan University, China; Julia Wang, Johnson & Johnson; Partha Nandy, Johnson & Johnson

Analysis of Statistical Tests to Compare Cumulative Proportion of Responders for Pain Data in Clinical Trials
Song Wang, PPD, Inc.

The Use of Contrast-Enhancing Lesions to Predict Imminent Relapse: Validating Cutter's Rule
Charity Johanna Morgan, The University of Alabama at Birmingham; Ashutosh Ranjan, The University of Alabama at Birmingham; Gary Cutter, University of Alabama at Birmingham

Competing Risks Methods in Safety Analysis of Oncology Clinical Trials
Sofia Paul, Novartis Pharmaceuticals Corporation; Bingqing Zhou, The University of North Carolina at Chapel Hill; Samit Hirawat, Novartis Pharma; Glen Laird, Novartis Pharmaceuticals Corporation

A Bootstrap Approach to Estimating Antibody Levels in Case of Non-Normal Data
Roger Maansson, Merck & Co., Inc.

Implementation of EWOC (Escalation With Overdose Controls) Adaptive Dose-Finding Design in a Phase IIA Clinical Trial
Catherine Bresee, Oschin Comprehensive Cancer Institute; Amir Steinberg, Oschin Comprehensive Cancer Institute; Jeremy Rudnick, Oschin Comprehensive Cancer Institute; Andre Rogatko, Oschin Comprehensive Cancer Institute

Comparison of Power for ANCOVA Models Based on Central Tendency versus Nonparametric Analysis of Cumulative Responders for Clinical Trials with Continuous Response Endpoints
Kevin L. Lawson, PPD, Inc.

Comparisons of Methods in Phase I Dose-Escalation Clinical Trial Designs
Liping Huang, Bayer HealthCare Pharmaceuticals

A General Framework of Adaptive Designs for Early-Phase Oncology Clinical Trials
Lixin Lang, Bristol-Myers Squibb; Ralph Raymond, Bristol-Myers Squibb

Using Pilot Study for Clinical Study Planning
Hongbin Gu, The University of North Carolina at Chapel Hill; Xiaofei Wang, Duke University

Decisionmaking in Post Clinical Trials
Heping Zhang, Yale University
8:35 AM

How to Define Regions in Multiregional Clinical Trials
Qi Zhang, Eli Lilly and Company; Yoko Tanaka, Eli Lilly and Company
8:35 AM

Relative Power and Robustness of Mixed Model, GEE, and MMRM Analysis of Alzheimer's Disease Treatment Trials
Steven D. Edland, University of California, San Diego
8:35 AM

Futility Assessment Utilizing Conditional Power in a Phase III Clinical Trial
Yan Sun, Amgen Inc.
8:35 AM

Time-Variant Response Patterns and Modeling Precise Assessment Time in Confirmatory Clinical Trials
Yoko Tanaka, University of Pittsburgh Graduate School of Public Health
8:50 AM

Operational Characteristics of a Go/No-Go Decision Rule in an Early Clinical Trial
Atalanta Ghosh, Johnson & Johnson; Jose Carlos Pinheiro, Johnson & Johnson; Paul Rothenberg, Johnson & Johnson
8:50 AM

Multinational Clinical Trials: A Perspective from Latin America
Carolina Cernadas, Schering Plough Argentina
8:55 AM

Evaluating personalized treatment strategies: Subset analyses do not avoid the loss of power due to subgroups with no treatment effect
Werner Vach, Institute of Medical Biometry and Medical Informatics; Rene dePont Christensen, University of Southern Denmark; Oke Gerke, Odense University Hospital
8:55 AM

Optimization of Error Spending Approach in Clinical Trials
Michael Baron, The University of Texas at Dallas; Yi Zhong, The University of Texas at Dallas
9:05 AM

Evaluation of Multiregional Clinical Trials: Statistical and Other Issues in Each Development Stage
Yuki Ando, Pharmaceuticals and Medical Devices Agency
9:15 AM

Variability Exploration in Six Phase III Diabetes Clinical Trials: Implications for Research Studies
Hua Guo, Merck Research Laboratories; Bret Musser, Merck Research Laboratories
9:20 AM

Conditional Power and Predictive Power Approaches to Interim Monitoring in Equivalence Trials
Xiaojiang Zhan, Merck & Co., Inc.
9:20 AM

EWOC Online: A Novel Web Application for Computing a Bayesian Phase I Design Method for Dose-Finding with Escalation with Overdose Control
Dror Berel, Cedars-Sinai Medical Center; Andre Rogatko, Oschin Comprehensive Cancer Institute
9:35 AM

Optimal Two-Stage Phase II Design Utilizing Partial Information for Long-Term Endpoints
Bo Huang, Pfizer Inc.; Enayet Talukder, Pfizer Inc.; Neal Thomas, Pfizer Inc.
9:35 AM

Evaluation of Common Statistical Methods in Randomized Delayed-Start Design of Progression Disease Clinical Trials
Bongin Yoo, Bristol-Myers Squibb; Thomas Kelleher, Bristol-Myers Squibb
9:35 AM

Two-Stage Designs with Additional Futility Tests for Phase II Clinical Trials with Heterogeneous Patient Populations
Myron N. Chang, University of Florida; Sin-Ho Jung, Duke University
10:05 AM

Clinical Trial Designs for Predictive Biomarker Validation: Theoretical Considerations and Practical Challenges
Daniel Sargent, Mayo Clinic; Sumithra Mandrekar, Mayo Clinic
10:35 AM

A Case Study of Using a Genomic Assay to Predict the Benefit of Chemotherapy in Treating Breast Cancer: Testing, Prediction, and Study Planning
William E. Barlow, Cancer Research and Biostatistics (CRAB); Carl Yoshizawa, Genomic Health, Inc.
11:00 AM

Measuring the Performance of Markers Used to Select Patient Treatment
Holly Janes, Fred Hutchinson Cancer Research Center
11:25 AM

Generalizing Evidence from Randomized Clinical Trials to Target Populations: The ACTG-320 Trial
Elizabeth Stuart, Johns Hopkins Bloomberg School of Public Health; Stephen R. Cole, The University of North Carolina at Chapel Hill
2:05 PM

Detecting a Cutoff Point for Predictive Biomarkers in Clinical Trials Using Contrast Tests
Jianliang Zhang, MedImmune
2:20 PM

Evaluating Medical Imaging Reader Performance in Clinical Trials
David L. Raunig, Pfizer Inc.; Patricia English, Pfizer Inc.
2:30 PM

Assessing the Impact of Partial Monitoring on Power Within Clinical Trials
Joe William Bero, Boston Scientific Corporation
2:45 PM

Choice of Multiple Comparison Procedure in Two Pivotal Clinical Trials for Approval of a New Pharmaceutical Product: Power and Aesthetics
Brian L. Wiens, Alcon Laboratories, Inc.; Alex Dmitrienko, Eli Lilly and Company
3:05 PM

Performance Characteristic of Sequential Probability Ratio Test (SPRT) for Data Monitoring Committee (DMC) Review in Drug-Eluting Stent Clinical Trials
Yun Lu, Boston Scientific Corporation; Huyuan Yang, Boston Scientific Corporation
3:05 PM

Tuesday, 08/03/2010
The Accuracy of Clinical Trial Inferences: The Saw Palmetto Experience
Jeannette Y. Lee, University of Arkansas for Medical Sciences; Page Moore, University of Arkansas for Medical Sciences; Shelly Lensing, University of Arkansas for Medical Sciences

Design, Implementation, and Results for a Bayesian Adaptive Randomization Trial for Targeted Therapy in Lung Cancer
Suyu Liu, MD Anderson Cancer Center; J. Jack Lee, MD Anderson Cancer Center

Statistical Programmers in the Pharmaceutical Industry
Chengying (Nancy) Wu, sanofi-aventis

Using Historical Data for a Transitional Decision of Single-Arm Phase II Clinical Trials
Zunqiu Chen, Oregon Health & Science University; Yiyi Chen, Oregon Health & Science University; Motomi Mori, Oregon Health & Science University

Hierarchical Testing Procedures for Secondary Endpoints in Clinical Trials
Thomas Kelleher, Bristol-Myers Squibb

Optimizing a Testing Procedure Based on Kernel Density Estimation for Comparing Two Treatments
Sibabrata Banerjee, Merck & Co., Inc.; Sunil Dhar, New Jersey Institute of Technology; Farid Kianifard, Novartis Pharmaceuticals Corporation; Hanzhe Zheng, Merck & Co., Inc.; Venkata Sasikiran Goteti, Merck & Co., Inc.

Using Statistical Concepts to Determine Risk Level of Randomized Clinical Trials That Compare Two Noninvestigational Therapies
Martin L. Lesser, Feinstein Institute for Medical Research; Nina E. Kohn, Feinstein Institute for Medical Research

Balancing Informativeness and Ethics in Clinical Trial Design
Valerii Fedorov, GlaxoSmithKline
8:35 AM

Personalized Medicine Trials in Non-Small Cell Lung Cancer
Michael Kosorok, The University of North Carolina at Chapel Hill; Yufan Zhao, Amgen Inc.; Donglin Zeng, The University of North Carolina at Chapel Hill; Mark Socinski, The University of North Carolina at Chapel Hill
9:00 AM

A Multilevel Modeling Approach to Investigating Treatment Effect Variability in Randomized Longitudinal Experiments
Joseph Rausch, University of Cincinnati College of Medicine/Cincinnati Children's Hospital
9:15 AM

Application of Bayesian Joint Modeling of Time-to-Event and Patient-Reported Outcomes in an Oncology Clinical Trial
Luping Zhao, Eli Lilly and Company; Wei Shen, Eli Lilly and Company; Haoda Fu, Eli Lilly and Company ; Michelle Denise Hackshaw, Eli Lilly and Company; Mark E. Boye, Eli Lilly and Company
9:15 AM

A Case Study of Issues with Subgroup Analysis for Medical Devices
Yao Huang, FDA/CDRH; Yunling Xu, FDA/CDRH
9:15 AM

Estimation of Treatment Effect Following a Clinical Trial with Adaptive Design
Xiaolong Luo, Celgene Corporation; Peter Ouyang, Celgene Corporation
9:20 AM

Propensity Score Matching in Randomized Clinical Trials
Zhenzhen Xu, University of Michigan; John David Kalbfleisch, University of Michigan
9:20 AM

A Graphical Approach to Multiple Test Procedures for Adaptive Phase II/III Clinical Trials
Martin Posch, Medical University of Vienna
9:25 AM

Admissibility of Naive Estimator Under LINEX Loss in a Two-Stage Design
AnqiI Sun, University of Florida; Mark Yang, University of Florida
10:05 AM

Use of Graphics in Clinical Trials
Frank E. Harrell, Jr., Vanderbilt University School of Medicine
10:35 AM

Sample Size Re-estimation in Crossover Trials
Adina Soaita, Pfizer Inc.; Byron Jones, Pfizer Inc.; Jerry J. Weaver, Pfizer Inc.
10:35 AM

Meta-Analysis for Rare Adverse Event Data from Clinical Trials
Brenda Crowe, Eli Lilly and Company
10:35 AM

Analysis of Missing Mechanism in IVUS Imaging Clinical Trials with Missing Covariates
Tianyue Zhou, sanofi-aventis; Ming-Xiu Hu, Millennium Pharmaceuticals, Inc.
10:35 AM

Evaluating Cardiovascular Risk in Diabetes Clinical Trials: Lessons Learned from Saxagliptin
J Mark Donovan, Bristol-Myers Squibb
10:35 AM

A Case Study of Graphics in Clinical Trials: The Role of Statistical Graphics in the Recent Submission/Approval of GSK's Votrient in the United States
Michael Durante, GlaxoSmithKline
10:55 AM

Handling Missing Data in Rheumatoid Arthritis Trials
Guoguang Ma, Amgen Inc.; Liyun Ni, Amgen Inc.; Ling Chen, Washington University School of Medicine
11:05 AM

Change-Point Analysis of Survival Data with Application in Clinical Trials
Xuan Chen, sanofi pasteur; Michael Baron, The University of Texas at Dallas
11:05 AM

Graphics for Exploratory Analysis and Reporting in Clinical Trials
Michael O'Connell, Tibco
11:15 AM

Evaluating Cardiovascular Risk in Diabetes Clinical Trials: An FDA Statistician's Perspective
Jon Todd Sahlroot, FDA
11:15 AM

Use Multiple Imputation to Handle Missing Data in Longitudinal Clinical Trials with Multiple Correlated Endpoints
Yahong Peng, Pfizer Inc.; Lian Liu, Roche Product Development in Asia Pacific; Ruifeng Xu, Merck Research Laboratories
11:20 AM

Evaluating the Effect of Early vs. Late ARV Regimen Change After Failing on an Initial Regimen: Results from the AIDS Clinical Trials Group Study A5095
Li Li, Emory University; Brent Johnson, Emory University; Joseph Eron, The University of North Carolina at Chapel Hill; Heather Ribaudo, Harvard University; Roy Gulick, Cornell University
11:20 AM

Communicating Clinical Trial Results the Statistical Graphic Way
Mat Soukup, FDA
11:35 AM

A Hybrid Geometric Select-and-Test Design Based on Treatment Failure Time and Toxicity
Peter F. Thall, MD Anderson Cancer Center
2:05 PM

An Improved Method for Testing Two Families of Endpoints
Haihong Li, Vertex Pharmaceuticals; Abdul J. Sankoh, Vertex Pharmaceuticals
2:05 PM

Missing Data in Clinical Trials
Herbert Thijs, I-Biostat
2:05 PM

Genes Selection and Components Retention for Supervised Survival Prediction Models
Keyue Ding, Queen's University
2:05 PM

Strategies for Global Drug Development: Bridging vs. Multiregional Clinical Trials
William Wang, Merck & Co., Inc.; William Malbecq, Merck & Co., Inc.
2:05 PM

Optimal Phase II Decision Rules in a Seamless PhaseII/III Clinical Trial
Bo Jin, Merck Research Laboratories
2:05 PM

Multiple Testing Problems with General Logical Restrictions in Clinical Trials
Alex Dmitrienko, Eli Lilly and Company; Ajit C. Tamhane, Northwestern University
2:20 PM

Missing Data in a Large Long-Term Clinical Trial: A Case Study
Dacheng Liu, Boehringer Ingelheim Pharmaceuticals, Inc.
2:25 PM

Who Needs Bayesian Phase I Trials?
Rick Chappell, University of Wisconsin-Madison
2:30 PM

Generalized Hypothesis Testing in Interim Treatment Selection with a Flexible Selection Margin
Yujun Wu, Sanofi-Aventis; Peng-Liang Zhao, sanofi-aventis
2:35 PM

Evaluating Statistical Methods to Establish Clinical Similarity of Two Biologics: A Real-Life Example
Lei Lei, Amgen Inc.
2:45 PM

Principal Stratification Methods for Evaluating Immunological Surrogate Endpoints in a Vaccine Efficacy Trial
Peter Gilbert, Fred Hutchinson Cancer Research Center
2:45 PM

Exploration of Regional Impact on Efficacy Data in Antidepressant Clinical Trials
Peiling Yang, FDA
2:45 PM

Regulatory and Statistical Issues in Multiregional Trials: Case Studies
Daphne T.Y. Lin, FDA; Greg Soon, CDER/FDA; Wen Zeng, FDA
3:05 PM

A Gatekeeping Multiple Comparison Procedure Based on the Hommel Test for Clinical Trials with Hierarchically Ordered Objectives
Thomas Brechenmacher, Dainippon Sumitomo Pharma Co., Ltd.; Jane Xu, Dainippon Sumitomo Pharma America, Inc.; Alex Dmitrienko, Eli Lilly and Company; Ajit C. Tamhane, Northwestern University
3:05 PM

Interval Estimation in Two-Stage, Drop-the-Losers Clinical Trials with Flexible Treatment Selection
Dan Neal, University of Florida; George Casella, University of Florida; Mark Yang, University of Florida; Samuel S. Wu, University of Florida
3:05 PM

Inference for Treatment Efficacy on Survival Probability in Randomized Clinical Trials with Noncompliance
Ying Zhou, University of California, Los Angeles
3:05 PM

Evaluation of Regional Treatment Effect in a Multiregional Clinical Trial
Yi Tsong, CDER/FDA; W-J Chang, National Health Research Institutes, Taiwan; Chin-Fu Hsiao, National Health Research Institutes, Taiwan; Hsiao-Hui Tsou, National Health Research Institutes, Taiwan
3:25 PM

Addressing the Missing Data Problem in Clinical Trials
Linda Yau, Genentech
3:25 PM

Wednesday, 08/04/2010
gsDesign Explorer: Easy-to-Use Open Source GUI- and R-Based Group Sequential Design Software
Keaven M. Anderson, Merck Research Laboratories; William Constantine, REvolution Computing; Jason B. Clark, Merck Research Laboratories

Multiplicity Adjustment in Clinical Trials
Annpey Pong, Merck & Co., Inc.

Handling of Missing Data in Clinical Trials: Findings of a National Research Council Study
Roderick Joseph Little, University of Michigan
8:35 AM

Efficient Early Phase Designs in Oncology Based on Evidence Synthesis
Jyotirmoy Dey, Novartis Pharmaceuticals Corporation; Wentao Feng, Novartis Pharmaceuticals Corporation
8:35 AM

The Case for Embedding a Detailed Statistical Analysis Plan in Clinical Trial Protocols
Chris Assaid, Merck Research Laboratories; Keaven M. Anderson, Merck Research Laboratories
8:35 AM

On the Use of Historical Information in Selecting Design Type for Phase II Oncology Trials
Yiyi Chen, Oregon Health & Science University; Rongwei (Rochelle) Fu, Oregon Health & Science University; Zunqiu Chen, Oregon Health & Science University
8:35 AM

The Benefit of Stratified Clinical Trials Revisited
Jitendra Ganju, Amgen Inc.; Kefei Zhou, Amgen Inc.
8:50 AM

Choice of Estimand, Trial Design, and Trial Conduct
James D. Neaton, University of Minnesota
9:00 AM

Forecasting Clinical Trial Enrollment: A Case Study
Zachary Skrivanek, Eli Lilly and Company
9:05 AM

Testing Small Center Events in Multicenter Trials Using Survival Modeling
Usha Sita Govindarajulu, Brigham and Women's Hospital, Harvard Medical School; Elizabeth J. Malloy, American University; James Dziura, Yale University
9:05 AM

Application of Methods for Assessing Risk-Benefit in Clinical Trials
Menghui Chen, Merck & Co., Inc.; Shailaja Suryawanshi, Merck & Co., Inc.
9:05 AM

Accuracy of Biomarker Testing and Its Impact on Targeted Therapy Validation
Meijuan Li, FDA; Estelle Russek-Cohen, FDA; Rong Tang, FDA
9:15 AM

Bayesian Adaptive Phase II/III Clinical Trial Design Using the Relationship Between Tumor Response and Survival
Donald Arthur Berry, MD Anderson Cancer Center; Haiying Pang, MD Anderson Cancer Center
9:20 AM

Assessing Treatment Effect in Clinical Trials with Dichotomous Endpoints
Gang Jia, Merck & Co., Inc.
9:20 AM

A 'Paradox' in the Use of an ANCOVA Model in Determination of Treatment Effect in Clinical Trials
Chi-Hse Teng, Amylin Pharmaceuticals; Larry Z. Shen, Amylin Pharmaceuticals; Ping Yan, Amylin Pharmaceuticals
9:35 AM

Evaluating Diagnostics Hypotheses in Proof-of-Concept Clinical Trials
Jane Fridlyand, Genentech
9:55 AM

The Advantageous Adaptive Randomization in Clinical Trials
Bob Zhong, Johnson & Johnson
10:35 AM

Key Considerations for Simulations to Optimize Dose-Finding Trials
Natalie Cheung Hall, Eli Lilly and Company
10:35 AM

An Adaptive Futility Monitoring Method with Time-Varying Conditional Power Boundary
Ying Zhang, The University of Iowa; William Clarke, The University of Iowa
10:55 AM

A Theory for Testing Hypotheses Under Covariate-Adaptive Randomization
Jun Shao, University of Wisconsin-Madison; Xinxin Yu, University of Wisconsin-Madison; Bob Zhong, Johnson & Johnson
10:55 AM

A Statistical Design for Investigating Skin Diffusion-Based Dose Response in Humans
Jihao Zhou, Allergan Pharmaceuticals, Inc.; Thomas Lin, Allergan Pharmaceuticals, Inc.; Susan Guo, Allergan Pharmaceuticals, Inc.; Barbara Scholz, Allergan Pharmaceuticals, Inc.
11:05 AM

A Bayesian Design for a Proof-of-Concept Study Comparing Rituxan in Combination with a New Drug to Rituxan Alone
Sharon C. Murray, GlaxoSmithKline; John F. Toso, GlaxoSmithKline; John W. Bauman, GlaxoSmithKline;
11:15 AM

Sensitivity Analyses Adjusting for Early Discontinuation of Study Medication in the RE-LY Trial: An Open-Label, Randomized, Active-Controlled, Time-to-Event Noninferiority Trial
Xiuyu Cong, Boehringer Ingelheim Pharmaceuticals, Inc.; Qiqi Deng, Boehringer Ingelheim Pharmaceuticals, Inc.; Susan Q. Wang, Boehringer Ingelheim Pharmaceuticals, Inc.
11:15 AM

A Hybrid Frequentist-Bayesian Approach to a Pilot Study
Nicole Blackman, GlaxoSmithKline
11:55 AM

Hierarchical Gaussian Power Prior Models for Adaptive Incorporation of Historical Information in Clinical Trials
Bradley P. Carlin, University of Minnesota; Brian P. Hobbs, University of Minnesota; Daniel Sargent, Mayo Clinic; Sumithra Mandrekar, Mayo Clinic
2:05 PM

Statistical Testing in Clinical Trial with Covariate Adaptive Randomization
H.M. James Hung, FDA; Sue-Jane Wang, FDA
2:05 PM

Sequential Design of Phase II--III Cancer Trials
Tze Leung Lai, Stanford University; Philip Lavori, Stanford University; Mei-Chiung Shih, Stanford University
2:05 PM

Bias in Oncology Time-to-Event Data Analysis
Din Chen, Georgia Southern University; Yuhlong Lio, The University of South Dakota; Yibin Wang, Novartis
2:05 PM

Comparing the Performance of Composite Endpoints and Responder Definitions with a Unified Modeling Framework for Multiple Endpoints Within Clinical Trials
David Andrae, PPD, Inc.
2:20 PM

Combining Information Across Studies for Clinical Trials: What We Have Learned at FDA's Center for Devices and Radiological Health
Laura Thompson, FDA/CDRH
2:30 PM

Properties of Re-Randomization Tests in Clinical Trials with Adaptive Randomization
Stephen Lake, Genzyme Corporation; Cyrus R. Mehta, Cytel Inc.; L. J. Wei, Harvard University
2:35 PM

Case Study: Benefits of an Adaptive Clinical Trial Design in Oncology
Darcy Hille, Merck & Co., Inc.; Christine K. Gause, Merck Research Laboratories; Jason B. Clark, Merck Research Laboratories; Sarah Hoagey, Merck & Co., Inc.; Keaven M. Anderson, Merck Research Laboratories
2:50 PM

Predictive Probability Approach for the Design and Analysis of Response and Toxicity Data in Cancer Clinical Trials
J. Jack Lee, MD Anderson Cancer Center; Guosheng Yin, The University of Hong Kong; Nan Chen, M D Anderson Cancer Center
2:55 PM

Weighted Randomization Test for Multi-Arm Randomized Clinical Trials
Feifang Hu, University of Virginia
3:05 PM

Strategies for Setting Up the Logistics in Early Phase Adaptive Design Clinical Trials
Eva R. Miller, ICON Clinical Research
3:05 PM

Drug Regimen Selection in Early-Stage Two-Arm Oncology Clinical Trials
Guohui Liu, Millennium Pharmaceuticals, Inc.; Xuedong Chi, Millennium Pharmaceuticals, Inc.
3:05 PM

Expected Frequency of Allowed Forced Allocations in a Multicenter Clinical Trial
Suvajit Samanta, Merck Research Laboratories; Olga Kuznetsova, Merck Research Laboratories
3:20 PM

Adding a Prediction Interval Futility Analysis to a Group Sequential Trial
John Loewy, ARIAD Pharmaceuticals; David Dorer, ARIAD Pharmaceuticals
3:25 PM

Effect of Patient Allocation Schemes on the Power of a Test for Treatment Effect
Fanni Natanegara, Eli Lilly and Company; Christel Faes, Hasselt University; Geert Molenberghs, I-BioStat; Craig Mallinckrodt, Eli Lilly and Company
3:35 PM

Thursday, 08/05/2010
Maximizing the Longitudinal Rate of Change with Multiple Outcome Measures to Improve the Design of Clinical Trials on Alzheimer's Disease
Chengjie Xiong, Washington University
8:35 AM

Biomarkers in Clinical Trials in the Development of Biologics and Risk Assessment
Samir Lababidi, FDA
8:50 AM

Calibration in the Continual Reassessment Method for Phase I Clinical Trials
Shing M. Lee, Columbia University; Ying Kuen Cheung, Columbia University
8:50 AM

Bayesian Adaptive Designs in Practice
Scott Berry, Berry Consultants, LLC; Jason Connor, Berry Consultants, LLC
9:00 AM

Considerations on the Study Design and Analysis of Vulvar and Vaginal Atrophy Studies
Ling Chen, FDA
9:05 AM

Exploring the Relationship Between UGT1A1 Genotypes in Maternal Blood and Infant Blood Samples and Bilirubin Levels in a Clinical Trial of Pregnant Women Treated with Boosted ATV
Wenhua Hu, Bristol-Myers Squibb; Victoria Wirtz, Bristol-Myers Squibb; Eric Vandeloise, Bristol-Myers Squibb; Stjohn McGrath, Bristol-Myers Squibb; Timothy Eley, Bristol-Myers Squibb; Awny Farajallah, Bristol-Myers Squibb; Shu-Pang Huang, Bristol-Myers Squibb
9:20 AM

Using Cardiovascular Disease Risk Functions in Public Health and Clinical Trial: The Framingham Study Experience
Ralph B. D'Agostino, Sr., Boston University
9:25 AM

Regulatory Considerations for Addressing Multiplicity Problems of Clinical Trials with Multiple Endpoints
Mohammad F. Huque, FDA
10:35 AM

Bayesian Hierarchical Models for Detecting Safety Signals in Clinical Trials
Haijun Ma, Amgen Inc.; Amy Xia, Amgen Inc.; Bradley P. Carlin, University of Minnesota
10:35 AM

Using Integrated Difference Between Two Kaplan-Meier Curves for Quantifying Treatment Contrast in Comparative Clinical Trials with Event Time Observations
Lihui Zhao, Harvard School of Public Health
10:35 AM

CTDesignExplorer: An Action Queue--Based Open-Source Simulation Experiment Platform for Evaluating Clinical Trial Designs
Yuanyuan Wang, University of Pittsburgh; Roger Day, University of Pittsburgh; Daniel Normolle, University of Pittsburgh
10:50 AM

Power Analyses for Negative Binomial Models with Application to Multiple Sclerosis Clinical Trials
Mallikarjuna Rettiganti, The Ohio State University; Haikady Nagaraja, The Ohio State University
10:50 AM

Quantifying the Cost in Power of Ignoring Covariate Imbalances in Clinical Trial Randomization
Jody Dyan Ciolino, Medical University of South Carolina; Wenle Zhao, Medical University of South Carolina; Yuko Y. Palesch, Medical University of South Carolina; Renee' Martin, Medical University of South Carolina
10:50 AM

Industry Perspective on the FDA Guidance on Multiplicity Issues
Walter W. Offen, Eli Lilly and Company
11:00 AM

Challenges in the Conduct of Clinical Trials in the Australasian Region
Val Gebski, University of Sydney
11:05 AM

The Use of Nomogram Predictions as Comparators for Adjuvant Treatment Studies in Prostate Cancer
Zhenyu Jia, University of California, Irvine; James Koziol, The Scripps Research Institute; Michael Lilly, University of California, Irvine; Dan Mercola, University of California, Irvine
11:05 AM

Trajectory of Postpartum Depression Screening Scores
Peter C. Wollan, Olmsted Medical Center; Barbara P. Yawn, Olmsted Medical Center
11:05 AM

Experience with Using Simulation Models to Plan for Drug Supply in Adaptive Trials
Nitin R. Patel, Cytel Inc.; Suvajit Samanta, Merck Research Laboratories; Pralay Senchaudhuri, Cytel Inc.; Christine Stocklin, Merck & Co., Inc.
11:15 AM

Methods to Test Treatment-by-Site Interaction Using Mediated Moderation: An Application to the TORDIA Clinical Trial
Kaleab Abebe, University of Pittsburgh; Satish Iyengar, University of Pittsburgh; David A. Brent, University of Pittsburgh
11:20 AM

Variations of and Types of Statistical Control for Multiplicity in Clinical Trials: The Academic Perspective
Joseph Massaro, Boston University; Ralph B. D'Agostino, Sr., Boston University
11:25 AM

Multiplicity in Clinical Trials: A European Perspective
Norbert Benda, BfArM; Joachim Roehmel , Institute for Prevention Research and Social Medicine
11:50 AM

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