ABSTRACT
Safety evaluation is critically important in clinical trials and is continuous throughout a drug's lifecycle. The focus of this chapter is on the evaluation of adverse events in clinical trials during drug development from pre-marketing to post-marketing authorization, throughout the lifecycle of a product. A well-defined, structured, systematic, and proactive process to promptly identify and evaluate potential safety risks is key to a successful safety program in drug development. The creation of a prospectively-defined program-level data collection and analysis plan (the Program Safety Analysis Plan, as recommended by the Safety, Planning, Evaluation and Reporting Team (Crowe et al., 2009) and regular reviews of aggregate data by a multidisciplinary safety management team, as recommended by the Council for International Organisations of Medical Sciences (CIOMS) Working Group VI (2005), are two key elements of such a systematic approach. These efforts have the potential to enhance understanding of the safety profile of the product and tailor use of the drug so that the benefits will outweigh the risks for the target patient population.
