ACDRS 2025 Session 4 - Statistics: Design, Analysis, and Interpretation of Clinical Trials

Date: 
Wednesday, May 14, 2025 - 8:00 am to Friday, May 16, 2025 - 4:00 pm
Location: 
University of California Washington Center (UCDC), 1st floor meeting room

Full map

1608 Rhode Island Ave NW, Washington, DC

This is Session 4 of 6. Must register for the entire 2025 Course and not per session.

Session Co-chairpersons:
Telba Irony, PhD, Senior Scientific Director, Quantitative Sciences, J&J Innovative Medicine
John Scott, PhD MA, Director, Division of Biostatistics, Center for Biologics and Evaluation Research, US Food and Drug Administration (FDA)

Lecturers

Bruce S. Binkowitz, PhD MSc

 Vice President, Biometrics, Arcutis
Joshua Galanter, MD MAS

Sr Medical Director, gRED OMNI Early Clinical Development, Genentech
Thomas E. Gwise, PhD Consultant
Telba Irony, PhD Senior Scientific Director, J&J Innovative Medicine
Richard D. Payne, PhD MS Senior Advisor - Statistics, Eli Lilly and Company
John Scott, PhD MA Director, Division of Biostatistics, Center for Biologics and Evaluation Research, US FDA
Kert Viele, PhD Director and Senior Statistical Scientist, Berry Consultants
Janet Wittes, PhD

Consultant
others to be confirmed  

Additional faculty - case study proctors

Charlie Gombar, PhD ACDRS Director
others to be confirmed  

Topics (subject to change)

  • 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
  • Data and Safety Monitoring Committees
  • 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
  • Co-development of a diagnostic and tailored therapeutic
  • Biomarkers and surrogate endpoints
  • Statistical issues related to design, analysis, and reporting of gene therapy clinical trials
  • Rare disease and pediatrics
  • Multi-regional clinical trials
  • Safety assessment and surveillance
  • Real-World Evidence