Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2021 Session 4: Statistics: Design, Analysis and Interpretation of Clinical Trials
Date:
Monday, September 27, 2021 - 10:00 am to Friday, October 1, 2021 - 3:00 pm
Location:
virtual/online
This is Session 4 of 6. Must register for the entire course and not per Session.
Session Chairperson: Stephen Ruberg, PhD, President, Analytix Thinking
Lecturers
Bruce S. Binkowitz, PhD |
Vice President, Biometrics, Arcutis |
Gregory Campbell, PhD |
President, GCStat Consulting LLC; former Director, Biostatistics Division, Center for Devices and Radiological Health, US Food and Drug Administration (FDA) |
Daniel Meyer, PhD |
Head of Statistics, Rare Disease Research Unit, Pfizer |
Richard Payne, PhD | Research Scientist, 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 |
Kert Viele, PhD |
Senior Statistical Scientist, Berry Consultants |
Additional faculty - case study proctors
Jesse Anderson, MPH | Team Lead, Clinical Services, Office of Computational Science, US FDA |
Erica Berzin, MS | Regulatory Affairs Director, NDA Partners |
Dean Bottino, PhD | Senior Scientific Director, Clinical Translational Modeling & Simulation Leader, Takeda Oncology |
Salvador Garcia, MD | Senior Medical Director ANZ & NAPAC, Eli Lilly and Company |
Charlie T. Gombar, PhD | ACDRS Director |
Diane K. Jorkasky, MD | Consultant to Pharma |
Karryn Lepley, MBA PMP | Associate Director, Portfolio Management, AbbVie |
Karolynn Leon, MA | Executive Director, Global Program Management, Novartis |
Dustin Little, MD | Global Clinical Lead, Renal, AstraZeneca |
Carl Peck, MD | Adjunct Professor, UCSF; former Director, Center for Evaluation and Research, US FDA |
Melissa Reyes, MD MPH DTMH | Medical Officer, Division of Pharmacovigilance, Office of Surveillance and Epidemiology, US FDA |
Becca Saenz, MD PhD | Medical Director, Respiratory and Allergic Group, Genentech |
Nilam Shah, PharmD RPh | Senior Director, Clinical Research and Development, Cara Therapeutics |
Alice Wang, MD | Director, Translational Development, Clinical Pharmacology, Bristol Myers Squibb |
Daniel Weiss, MD | Vice President, Early Clinical Development, Schrodinger |
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
- Digital health innovations