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
Case Study in the Use of Bayesian Hierarchical Modeling and Simulation
for Design and Analysis of a Clinical Trial Bill Gillespie
(Pharsight)
Slideshow
Adaptation of Clinical Trial Design and Inference
James Hung (FDA)
Slides
Plenary Session II: Longitudinal Data Analysis - Issues and Recommendations
"A Note on Modeling the Covariance Structure in Longitudinal Clinical
Trials" - Devan V. Mehrotra (MERCK)
Slideshow
"Analyzing Incomplete Longitudinal Clinical Trial Data"
- Geert Molenberghs (Limburgs Universitair Centrum Belgium)
Slides
"Considerations Regarding Choice of the Primary Analysis in Longitudinal
Trials With Dropouts: An FDA Perspective" - Bob O'Neill (FDA)
Slideshow
"Longitudinal Data Analysis: Issues and Recommendations"
- Tom Louis (Johns Hopkins University)
Slideshow
Plenary Session III: Trial Monitoring
"On Superiority of Adaptive Sequential Designs" - Qing
Liu (Johnson & Johnson) and Gordon Pledger (Johnson & Johnson)
Slides
"Changing Trial Design on the Fly" - Janet Wittes (Statistics
Collaborative)
Slideshow
"Interim Analysis in Clinical Trials: A Bayesian Approach in the
Regulatory Setting" - Telba Irony (FDA) and Gene Pennello (FDA)
Slideshow 1
| Slideshow 2
Plenary Session IV: Perspectives on Safety Issues in Drug Development
Industry Perspective: "Perspectives of Safety Issues in Drug Development"
- Tim Costigan (Eli Lilly)
Slideshow
"Perspectives on Safety Issues in Drug Development" - George
Rochester (FDA)
Slides
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
| Slides
"Issues in the Analysis of Failure Time Data" - Rebecca
Betensky (Harvard School of Public Health)
Slideshow
"Industry Issues: Dataset Preparation for Time to Event Analysis"
- Davis Gates (Schering Plough Research Institute)
Slideshow
Parallel Session 1-B: Multinational Trials
"Delivering Robust Outcomes from Multinational Trials: Principles
and Strategies" - Andreas Sasheygi (Eli Lilly)
Slideshow
"Considerations for the Choice and Interpretation of Endpoints in
International Trials of Antiretroviral Therapies" - Victor DeGruttola
(Harvard School of Public Health)
Slideshow
"Multi-Clinic and Multi-National Trials: A Regulatory Perspective"
- Charles Anello (FDA)
Slideshow
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)
Slideshow
Sample Size Selection for Microarray based Gene Expression Studies
- Greg Warnes (Pfizer Global R&D), Fasheng Li (Smith Hanley Consulting
Group)
Slideshow
"Cross-Study Validation of Molecular Classification in Cancer"
- Giovanni Parmigiani
Abstract
Selection of Differential Expression Genes in Microarray Experiment"
- James Chen (FDA)
Slideshow
Parallel Sessions II
Parallel Session 2-A: Analysis Database (AdAM)
An Academic Perspective from the "Real World" - David H.
Christiansen, DrPH (Christiansen Consulting)
Slides
A Regulatory Perspective - Steve Wilson, DrPH (Division of Biometrics
II / FDA / CDER)
Slideshow
The SCIENCE: In Analysis Databases: The Value and Challence
of One-PROC-Away - Russell W. Helms, Ph.D. (Rho, Inc.)
Slides
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
| Slideshow
| Slides
"Rapid Cycle Analysis of Vaccine Safety" - Bob Davis (University
of Washington)
Abstract
Parallel Session 2-C: Preclinical and Early Clinical Data
"Evaluation of Live Phase Results from Carcinogenicity Studies"
- Wherly Hoffman, Ph.D. (Eli Lilly)
Slideshow
"Peto Trend Test: Investigating the Impact of Tumor Misclassification"
- Amrik Shah (Schering-Plough), Melody Goodman (Harvard University)
Slideshow
"Statistical Issues in Review of Carcinogenicity Studies Using Transgenic
Mice" - Karl K. Lin, Ph. D. (FDA), Feng Zhou (FDA)
Slideshow
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)
Slideshow
"Maximizing Power and Minimizing Treatment Failures Using Randomization"
- William Rosenberger (University of Maryland at Baltimore County), Feifang
Hu (University of Virginia)
Slides
"Computer Intensive and Re-Randomization Tests in Clinical Trials"
- Tom Hammerstrom, Ph.D. (FDA)
Slideshow
Parallel Session 3-B: Diagnostic Evaluation
"Methods Comparison Studies for Quantitative Nucleic Acid Assays"
- Jacqueline Law (Art DeVault Roche Molecular Systems)
Slideshow
"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)
Slides
"Propensity Scores Methodology for Receiver Operating Characteristic
(ROC) Analysis" - Marina Kondratovich (FDA)
Slideshow
Parallel Session 3-C: Getting the Dose Right
"Dose Spacing in Early Dose Response Clinical Trial Designs"
- Naitee Ting, Pfizer
Abstract
| Slideshow
Adaptive Dose Selection: Getting the Most Out of What You Currently
Know - Andy Grieve (Pfizer and University of Kent, UK)
Abstract
| Slides
Risk and Benefit Assessments for Optimal Dose Selection Based on
Exposure Response Peter Lee (FDA)
Abstract
| Slides
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)
Slideshow
"On Surrogate Endpoints in HIV Vaccine Efficacy Trials"
- Steve Self (Fred Hutchinson Cancer Research Center)
Slideshow
Special Interest Session B: Statistical Methods in Advisory Panel Meetings
FDA Advisory Committees - Mary A. Foulkes, Ph.D. (FDA)
Slideshow
Special Interest Session C: Statistical Issues in Medical Devices
"Testing for Both Superiority and Noninferiority - William C.
Blackwelder (Biologics Consulting Group)
Slideshow