For patients with cancer treated with palliative intent, quality of life (QOL) is a critical aspect of treatment decision-making, alongside survival. In some cases, patients with advanced cancer have even prioritized QOL over survival. However, submission of QOL data are not mandatory for oncology drugs seeking regulatory approval by the US Food and Drug Administration (FDA) or European Medicines Agency (EMA). Thus, despite the value of QOL as a constituent of clinical benefit, it often does not appear to be a considerable factor in drug approval.

Clinical trials with the aim of drug registration are designed with primary objectives focused on demonstrating traditional components of clinical benefit, such as overall survival (OS). As such, trials are therefore powered to capture the statistically significant differences in these traditional end points, often without consideration of QOL evidence. However, regulatory approval is frequently based on surrogate outcomes for survival or clinical effectiveness, such as progression-free survival (PFS) or response rate. While such methods may serve to expedite drug approval, a drug’s final efficacy (or the lack thereof) may not be apparent at the time of market authorization. Given an absence of clinically meaningful survival gains, any increase in length of life may not be associated with comparable increases in QOL....