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ABOUT THIS WEBINAR

The appropriate planning and conduct of integrated clinical trial safety analyses is critical to the success of drug marketing applications submitted to the FDA. As the safety analytics field is dynamic and evolving, continuous learning is required for the multiple disciplines (medical staff, statisticians, medical writers, etc.) that need to collaborate to create the necessary integrated tables, figures, and analyses.

This webinar will discuss how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. In addition, common mistakes seen in integrated analyses will be discussed to help you avoid making the same mistakes.

INTENDED AUDIENCE

• Pharmaceutical regulatory scientists, clinical reviewers, medical professionals, data scientists, statisticians, statistical programmers, medical writers working on integrated clinical trial safety analyses for new drug marketing applications.
• We will not be discussing trial data for generic drug applications.

TOPICS COVERED

• Importance of early planning
• Types of issues to discuss at FDA Type C meeting for integrated safety
• How to create integrated analysis sets for safety assessment
• Appropriate analytical and statistical methods when combining clinical trial data from multiple studies

LEARNING OBJECTIVES

• Understanding when to contact the FDA for discussion around integrated safety analysis plans.
• Understanding common mistakes in integrated safety analysis.
• Using best practices for integrated safety analysis.

FDA SPEAKERS | PANELISTS

Common Mistakes When Pooling Clinical Trial Safety Data
Mary Nilsson
Executive Director-Statistics
Safety Analytics Working Group (FDA|PHUSE)
Eli Lilly

FDA Type C Meetings on ISS Safety Analysis Strategy and Related Data Requirements
Veronica Pei, M.D., MPH, MEd
Associate Director for Biomedical Informatics
DBIRBD | ODES | OND | CDER

PANELIST
Gregory Levin, Ph.D.
Associate Director for Statistical Science and Policy
Office of Biostatistics (OB)
Office of Translational Sciences (OTS) | CDER

FDA RESOURCES

• FINAL FDA Guidance: Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products
• DRAFT FDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products