Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

Background: Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources.

Methods: In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle.