ABSTRACT
It has long been understood that the benefits of a medical product should be assessed in the context of the risks or harms associated with that product, and vice versa. Until recently, however, drug development and regulatory decisions were usually based on informal, qualitative weighing of benefits and risks, often leading to opaque decisions. Now, pharmaceutical companies and other clinical organizations are increasingly using 146structured benefit–risk assessments (BRAs), sometimes including sophisticated quantitative methods, as part of their decision-making processes. There are also vast efforts from health authorities and academia to standardize, streamline, and improve the BRA process. In the wake of these initiatives, the field of structured BRA has blossomed, with major advances in methodology and implementation. As a result, a large number of methods have been proposed to facilitate the BRA, which also further complicates the BRA picture. In this chapter, we will discuss these different BRA methodologies and recommend a set of systematic methods for general use in the pharmaceutical industry. We will also describe some criteria to select the methods as well as challenges in applying them.
