Tutorial 02: Analysis of Safety Data from Clinical Trials

 This tutorial is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or contract research organisation (CRO).  The aim of this tutorial is to provide a basic understanding of the underlying methodology and the current guidelines on safety data.  Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.  Opportunities for prospective planning of safety analysis at the project level will be discussed.  The presentations will also include case studies.

At the conclusion of this tutorial, participants will be able to:

• Understand relevant guidelines and regulatory requirements
• Contribute to safety analysis plans
• Assess statistical safety analyses
• Identify pitfalls in safety analyses