2003 FDA/Industry Statistics Workshop
September 18-19, 2003
Hyatt Regency
Bethesda, Maryland

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Thursday September 18, 2003
Plenary Session I: Flexible Designs
“Select the Winner in Drug Development” - Gordon Lan, Aventis Pharmaceuticals
Abstract MS Word Format
“Case Study in the Use of Bayesian Hierarchical Modeling and Simulation for Design and Analysis of a Clinical Trial”– Bill Gillespie (Pharsight)
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“Adaptation of Clinical Trial Design and Inference” – James Hung (FDA)
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Plenary Session II: Longitudinal Data Analysis - Issues and Recommendations
"A Note on Modeling the Covariance Structure in Longitudinal Clinical Trials" - Devan V. Mehrotra (MERCK)
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"Analyzing Incomplete Longitudinal Clinical Trial Data" - Geert Molenberghs (Limburgs Universitair Centrum Belgium)
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"Considerations Regarding Choice of the Primary Analysis in Longitudinal Trials With Dropouts: An FDA Perspective" - Bob O'Neill (FDA)
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"Longitudinal Data Analysis: Issues and Recommendations" - Tom Louis (Johns Hopkins University)
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Plenary Session III: Trial Monitoring
"On Superiority of Adaptive Sequential Designs" - Qing Liu (Johnson & Johnson) and Gordon Pledger (Johnson & Johnson)
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"Changing Trial Design on the Fly" - Janet Wittes (Statistics Collaborative)
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"Interim Analysis in Clinical Trials: A Bayesian Approach in the Regulatory Setting" - Telba Irony (FDA) and Gene Pennello (FDA)
Slideshow 1 Powerpoint Format | Slideshow 2 Powerpoint Format
Plenary Session IV: Perspectives on Safety Issues in Drug Development
Industry Perspective: "Perspectives of Safety Issues in Drug Development" - Tim Costigan (Eli Lilly)
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"Perspectives on Safety Issues in Drug Development" - George Rochester (FDA)
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Friday September 19, 2003
Parallel Sessions
Parallel Session 1-A: Time to Event Data
"An Efficient Alternative to the Cox Model for Small Time-to-Event Trials" - Devan V. Mehrotra (Merck)
Abstract MS Word Format | Slides PDF Format
"Issues in the Analysis of Failure Time Data" - Rebecca Betensky (Harvard School of Public Health)
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"Industry Issues: Dataset Preparation for Time to Event Analysis" - Davis Gates (Schering Plough Research Institute)
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Parallel Session 1-B: Multinational Trials
"Delivering Robust Outcomes from Multinational Trials: Principles and Strategies" - Andreas Sasheygi (Eli Lilly)
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"Considerations for the Choice and Interpretation of Endpoints in International Trials of Antiretroviral Therapies" - Victor DeGruttola (Harvard School of Public Health)
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"Multi-Clinic and Multi-National Trials: A Regulatory Perspective" - Charles Anello (FDA)
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Parallel Session 1-C: Genomics in Drug Discovery and Development
"Complex Adaptive Systems and Human Health: Statistical Approaches in Pharmacogenomics" - Kim Zerba (Bristol-Myers-Squibb)
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“Sample Size Selection for Microarray based Gene Expression Studies” - Greg Warnes (Pfizer Global R&D), Fasheng Li (Smith Hanley Consulting Group)
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"Cross-Study Validation of Molecular Classification in Cancer" - Giovanni Parmigiani
Abstract MS Word Format
“Selection of Differential Expression Genes in Microarray Experiment" - James Chen (FDA)
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Parallel Sessions II
Parallel Session 2-A: Analysis Database (AdAM)
An Academic Perspective from the "Real World" - David H. Christiansen, DrPH (Christiansen Consulting)
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A Regulatory Perspective - Steve Wilson, DrPH (Division of Biometrics II / FDA / CDER)
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The SCIENCE™: In Analysis Databases: The Value and Challence of One-PROC-Away - Russell W. Helms, Ph.D. (Rho, Inc.)
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Parallel Session 2-B: Post-Marketing Issues
"Perspectives on Automated Methods for Pharmacovigilance Signal Detection" - A. Lawrence Gould, Ph. D. (Merck), Peter K. Honig, MD, MPH (Merck)
Abstract MS Word Format | Slideshow Powerpoint Format | Slides PDF Format
"Rapid Cycle Analysis of Vaccine Safety" - Bob Davis (University of Washington)
Abstract MS Word Format
Parallel Session 2-C: Preclinical and Early Clinical Data
"Evaluation of Live Phase Results from Carcinogenicity Studies" - Wherly Hoffman, Ph.D. (Eli Lilly)
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"Peto Trend Test: Investigating the Impact of Tumor Misclassification" - Amrik Shah (Schering-Plough), Melody Goodman (Harvard University)
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"Statistical Issues in Review of Carcinogenicity Studies Using Transgenic Mice" - Karl K. Lin, Ph. D. (FDA), Feng Zhou (FDA)
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Parallel Sessions III
Parallel Session 3-A: Randomization - Uses and Abuses
"Uses and Abuses of (Adaptive) Randomization:.An Industry Perspective" - Benjamin Lyons, Ph. D. (Johnson & Johnson), Akiko Okamoto, Sc.D. (Johnson & Johnson)
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"Maximizing Power and Minimizing Treatment Failures Using Randomization" - William Rosenberger (University of Maryland at Baltimore County), Feifang Hu (University of Virginia)
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"Computer Intensive and Re-Randomization Tests in Clinical Trials" - Tom Hammerstrom, Ph.D. (FDA)
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Parallel Session 3-B: Diagnostic Evaluation
"Methods Comparison Studies for Quantitative Nucleic Acid Assays" - Jacqueline Law (Art DeVault Roche Molecular Systems)
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"A Cautionary Note on the Robustness of Latent Class Models for Estimating Diagnostic Error without a Gold Standard" - Paul Albert (NCI) and Lori Dodd (NCI)
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"Propensity Scores Methodology for Receiver Operating Characteristic (ROC) Analysis" - Marina Kondratovich (FDA)
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Parallel Session 3-C: Getting the Dose Right
"Dose Spacing in Early Dose Response Clinical Trial Designs" - Naitee Ting, Pfizer
Abstract MS Word Format | Slideshow Powerpoint Format
“Adaptive Dose Selection: Getting the Most Out of What You Currently Know” - Andy Grieve (Pfizer and University of Kent, UK)
Abstract MS Word Format | Slides PDF Format
“Risk and Benefit Assessments for Optimal Dose Selection Based on Exposure Response” – Peter Lee (FDA)
Abstract | Slides PDF Format
Special Interest Sessions
Special Interest Session A: Surrogate Endpoints in Vaccine Efficacy Trials
"Licensing a Vaccine on the Basis of Surrogate Endpoints: A Practical Example" - Robert Kohberger (Wyeth)
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"On Surrogate Endpoints in HIV Vaccine Efficacy Trials" - Steve Self (Fred Hutchinson Cancer Research Center)
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Special Interest Session B: Statistical Methods in Advisory Panel Meetings
FDA Advisory Committees - Mary A. Foulkes, Ph.D. (FDA)
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Special Interest Session C: Statistical Issues in Medical Devices
"Testing for Both Superiority and Noninferiority - William C. Blackwelder (Biologics Consulting Group)
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