Surrogate end points in oncology: the speed–uncertainty trade-off from the patients’ perspective

Abstract

Surrogate end points in drug regulation are thought to reduce the time required to bring new drugs to market; however, only a few of the drugs approved on the basis of these outcomes have subsequently demonstrated robust improvements in overall survival (OS). If the FDA and other regulators were to shift their priority to patient-centred outcomes, such as OS, I argue that such a shift would probably lead to fewer, but also a higher standard of drugs entering the market, potentially with faster approval decisions because novel therapies would initially be tested in later lines and in patients with a worse prognosis.