Sex as a biological variable in early-phase oncology clinical trials: enhancing the path to personalised medicine

Abstract

Sex is an essential biological variable that influences the development, progression and response to treatment in cancer. Despite this, early-phase cancer clinical trials frequently neglect to consider sex as a variable, creating a barrier to the development of personalised medicine. This article argues that failure to identify and infer sex differences in early-phase clinical trials may result in suboptimal dosing, underestimation of toxicity, and the failure to identify potential sex-specific responses to new systemic anticancer therapies. There should be a greater focus on sex as a biological variable in drug development so that thoughtful and deliberate study design can bring precision to the development of new systemic cancer therapies.