ACDRS 2023 Session 4 - Statistics: Design, Analysis, and Interpretation of Clinical Trials

Wednesday, June 14, 2023 - 8:00 am to Friday, June 16, 2023 - 4:00 pm
University of California Washington Center (UCDC), 1st floor meeting room

1608 Rhode Island Ave NW, Washington, DC

This is Session 4 of 6. Must register for the entire 2023 Course and not per session.

Session Co-chairpersons:
Telba Irony, PhD, Senior Scientific Director, The Janssen Pharmaceutical Companies of Johnson & Johnson
Freda Cooner, PhD, Senior Director - Statistics, Eli Lilly & Company


Bruce S. Binkowitz, PhD

Vice President, Biometrics, Arcutis

Freda Cooner, PhD

Senior Director - Statistics, Eli Lilly & Company
Telba Irony, PhD Senior Scientific Director, The Janssen Pharmaceutical Companies of Johnson & Johnson
Richard D. Payne, PhD Senior Advisor - Statistics, 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
Estelle Russek-Cohen, PhD Principal, ERCStat LLC

Kert Viele, PhD

Senior Statistical Scientist, Berry Consultants
Wenquan Wang, PhD

Senior Director, Rare Disease Research Unit, Pfizer

Additional faculty - case study proctors

Cynthia DeKlotz, MD PhD FAAD

Director, Clinical Development – Immunology, Janssen Research & Development

Charlie Gombar, PhD ACDRS Director
Jiajun (JJ) Liu, PharmD MSc Pharmacometric/Biopharmaceutics Reviewer, Division of Pharmacometrics, Office of Clinical Pharmacology/OTS/CDER, US Food and Drug Administration
Carl C. Peck, MD Founder and Partner, NDA Partners


  • 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
  • Real-World Evidence