Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2023 Session 4 - Statistics: Design, Analysis, and Interpretation of Clinical Trials
Date:
Wednesday, June 14, 2023 - 8:00 am to Friday, June 16, 2023 - 4:00 pm
Location:
University of California Washington Center (UCDC), 1st floor meeting room
1608 Rhode Island Ave NW, Washington, DC
This is Session 4 of 6. Must register for the entire 2023 Course and not per session.
Session Co-chairpersons:
Telba Irony, PhD, Senior Scientific Director, The Janssen Pharmaceutical Companies of Johnson & Johnson
Freda Cooner, PhD, Senior Director - Statistics, Eli Lilly & Company
Lecturers
Bruce S. Binkowitz, PhD |
Vice President, Biometrics, Arcutis |
Freda Cooner, PhD |
Senior Director - Statistics, Eli Lilly & Company |
Telba Irony, PhD | Senior Scientific Director, The Janssen Pharmaceutical Companies of Johnson & Johnson |
Richard D. Payne, PhD | Senior Advisor - Statistics, Eli Lilly and Company |
William R. Prucka, PhD | Principal Research Scientist, AdvAn Science Driven Adaptive Program, Eli Lilly and Company |
Frank W. Rockhold, PhD | Professor of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University School of Medicine |
Stephen J. Ruberg, PhD |
President, Analytix Thinking LLC |
Estelle Russek-Cohen, PhD | Principal, ERCStat LLC |
Kert Viele, PhD |
Senior Statistical Scientist, Berry Consultants |
Wenquan Wang, PhD |
Senior Director, Rare Disease Research Unit, Pfizer |
Additional faculty - case study proctors
Cynthia DeKlotz, MD PhD FAAD |
Director, Clinical Development – Immunology, Janssen Research & Development |
Charlie Gombar, PhD | ACDRS Director |
Jiajun (JJ) Liu, PharmD MSc | Pharmacometric/Biopharmaceutics Reviewer, Division of Pharmacometrics, Office of Clinical Pharmacology/OTS/CDER, US Food and Drug Administration |
Carl C. Peck, MD | Founder and Partner, NDA Partners |
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
- Multi-regional clinical trials
- Safety assessment and surveillance
- Real-World Evidence