ACDRS 2024 Session 4 - Statistics: Design, Analysis, and Interpretation of Clinical Trials

Date: 
Tuesday, May 14, 2024 - 8:00 am to Thursday, May 16, 2024 - 4:00 pm
Location: 
University of California Washington Center (UCDC), 1st floor meeting room

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1608 Rhode Island Ave NW, Washington, DC

This is Session 4 of 6. Must register for the entire 2024 Course and not per session.

Session Co-chairpersons:
Telba Irony, PhD, Senior Scientific Director, The Janssen Pharmaceutical Companies of Johnson & Johnson
John Scott, PhD, Director, Division of Biostatistics, Center for Biologics and Evaluation Research, US Food and Drug Administration (FDA)

 

 

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