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