Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2022 Session 4 - Statistics: Design, Analysis, and Interpretation of Clinical Trials
Date:
Monday, June 6, 2022 - 10:00 am to Friday, June 10, 2022 - 3:00 pm
Location:
virtual/online
This is Session 4 of 6. Must register for the entire 2022 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) |
Michelle Casey, 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
Siddique Abbasi, MD MSc FACC | Executive Medical Director and Global Development Lead, Amgen |
Daniel Abramzon, MBS | Project Team Leader, gRED Portfolio Management & Operations, Genentech, A Member of the Roche Group |
Lawrence Allan | Regulatory Health Project Manager, Office of Program Operations, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA) |
Jesse Anderson, MPH | Lead Project Manager, Division of Regulatory Review & Research, Office of Computational Science, CDER, US FDA |
Cynthia DeKlotz, MD FAAD | Director, Immunology Clinical Development (Dermatology), Janssen Research & Development |
Charlie Gombar, PhD | ACDRS Director |
Anandi Kotak, MS MD FACOG | Senior Physician, Division of Urology, Obstetrics & Gynecology, OND, CDER, US FDA |
Rebecca Kunder, MD PhD | Medical Director, Early Clinical Development, Genentech, A Member of the Roche Group |
Kofi Mensah, MD PhD | Director, Early Clinical Development, Bristol Myers Squibb |
Magda Michna, PhD | Chief Global Clinical, Medical and Regulatory Affairs Officer, AcuFocus, Inc. |
Melicent Peck, MD | Project Team Leader & Senior Medical Director, Early Clinical Development, Genentech, A Member of the Roche Group |
Jorge Safi, MD PhD | Head Patient Safety, Novartis |
Lauren Schrier, MBA | Vice President, Marketing, Immunovant |
Kaycee Sink, MD MAS | Principal Medical Director and Global Development Leader, Genentech, a member of the Roche Group |
Alice Wang, MD | Director, Translational Development Clinical Pharmacology, Bristol Myers Squibb |
others to be confirmed |
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