ABSTRACT
Benefit–risk (B–R) assessment is required at the time a product is submitted for marketing authorization. Data for this assessment typically come from clinical trials (randomized and nonrandomized). However, B–R assessment is an ongoing process and assessment beyond the initial marketing application will require data from the broad use of the product in the real-world setting. Fortunately, such data have become increasingly available in recent years. Examples include spontaneous reports of adverse events and data registered in administrative and registry databases. Administrative databases describe the patient’s usage of, as well as experience with, all kinds of pharmaceutical 118products. In this chapter, we will discuss these additional data sources and how the available data could be used to assist B–R assessment. We will also describe a set of principles on how data from these different sources could be examined together to provide an overall picture of the B–R profile of a product.
