Statistics: Design, Analysis & Interpretation of Clinical Trials
Session Co-chairs: Telba Irony, J&J Innovative Medicine & John Scott, US FDA
Details
- Type Event
- Date -
- Time -
- Location University of California Washington Center Multipurpose Room, 1st floor
About
Must be registered in advance to attend.
Topics
- Role of confirmatory phase in drug development
- Statistical principles for clinical trials
- Choice of control groups in clinical trials
- Study objectives, hypothesis testing, sample size, and probability of study success
- Multiplicity in clinical trials
- Missing data and estimands
- Interim analysis
- Bayesian statistics
- The design, analysis, and interpretation of a clinical endpoint trial
- Modeling and simulation
- Adaptive design in clinical trials and optimization
- Design and analysis of adaptive clinical trials
- Enrichment designs
- Perspectives for developing a targeted medicine
- Co-development of a diagnostic and targeted medicine
- Statistical issues related to design, analysis, and reporting of gene therapy clinical trials
- Statistical issues related to design, analysis, and reporting of clinical trials in rare disease and in pediatrics
- Safety assessment and surveillance
- Pharmacovigilance
Speakers
- Telba Irony, PhD, Senior Scientific Director, Quantitative Sciences, J&J Innovative Medicine
- David Ohlssen, PhD, Head of Advanced Exploratory Analytics, Novartis
- Richard Payne, PhD, Immunology Lead, Clinical Design Statistics, Eli Lilly and Company
- John Scott, PhD, Director, Division of Biostatistics, Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration (to be confirmed)
- Kert Viele, PhD, Senior Statistical Scientist, Berry Consultants
- Janet Wittes, PhD, Affiliate Professor of Biostatistics, Department of Population Health, Schmidt College of Medicine, Florida Atlantic University
- Others to be confirmed