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

Full map

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, 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
Thomas E. Gwise, PhD Consultant
Telba Irony, PhD Senior Scientific Director, J&J Innovative Medicine
Mark Levenson, PhD Director, Division of Biometrics VII, Center for Drug Evaluation and Research, US FDA
Bennett Levitan, MD PhD Senior Director, Benefit-risk Assessment/Epidemiology, J&J Innovative Medicine
Richard D. Payne, PhD MS Senior Advisor - Statistics, 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
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

Additional faculty - case study proctors

Cynthia DeKlotz, MD PhD FAAD

Director, Clinical Development – Immunology, J&J Innovative Medicine
Kristin Fiorino, MD Global Development Medical Director, CVRM, AstraZeneca
Charlie Gombar, PhD ACDRS Director
Adam Levy, MD Executive Director, Head of the Pediatric Center of Excellence, BMS
Robert J Nadeau, PhD Clinical Pharmacology Fellow, Walter Reed Army Institute of Research
Amrita Pati, PhD Head of Computational Biology for Clinical Biomarkers and Diagnostics, Amgen
Jorge Safi, Jr., MD PhD Head of Patient Safety, Novartis
Nicole Teig, PharmD RPh Senior Director, Global Regulatory Affairs - North America, Diabetes and Obesity, Eli Lilly

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
  • 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