The earlier the better? Or better late than never? Dose optimization in oncology

Abstract

In this issue of the Journal, Korn et al. ( 1) posit dose optimization during anticancer agent development should occur only after the investigational agent has shown clinical activity and that “patient and public health interests may be better served” if performed after phase II or III testing vs in first-in-human or other early-phase assessments. The title provides a convenient launching point because “whether and when?” are important questions, but for many, including patients, investigators, and the pharmaceutical industry, the most pressing question has been “how?” ( Figure 1).