Incorporating quality of life measures into drug approvals: What is the FDA's Stance?

By Dr Nicola Davies

For over two decades, the US Food and Drug Administration (FDA) has encouraged the incorporation of patient perspectives into drug development. A major component of the patient perspective is a drug’s effect on Quality of Life (QoL) – a concept that has always been a heterogeneous entity that lacks clear definition.

The FDA suggests that QoL is ‘an abstract, multidimensional concept, which defines a patient’s satisfaction with life in specific domains that they consider significant.’ QoL is best assessed through patient-reported outcomes (PROs), which are direct reports from the patient on their health and functional status. Most clinical trials today collect PROs as a routine part of their outcome assessment; however, there is no clear guidance on the analysis and interpretation of PROs data. This leaves the pharmaceutical industry with a major question: How much emphasis does the FDA place on QoL outcomes?