ABSTRACT
Every medicinal product is targeted to have some benets for patients but inevitably comes with certain risks, also known as side effects. Benet-risk assessment (BRA) refers to a judgment made based on available evidence regarding whether or not the benets outweigh the risks for a particular product in the context of treatment options available to patients. Therefore, BRA is important and common for drug development and life-cycle management. Sponsors perform a BRA of a candidate drug to determine whether further clinical development is warranted and, if so, create the development plan to accumulate evidence. For regulators, BRA in the context of a new drug application is a central element of the scientic evaluation of a marketing authorization application and related variations (EMA 2007). Health-care providers and patients evaluate benets versus risks for the available treatment options to decide on the best treatment course for individual patients.
