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 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.
Who Should Attend
This tutorial is designed for biostatisticians, medical writers, clinical researchers, drug safety specialists, project managers, and investigators.
At the conclusion of this tutorial, participants should be able to:
- Examine relevant guidelines and regulatory requirements for clinical trials
- Recognise how to contribute to safety analysis plans
- Assess statistical safety analysis and identify pitfalls in safety analysis
- Recognise the impact of benefit/risk assessment in safety data