Improper Dose In Phase II Trials Can ‘Make Or Break’ Drug Program, FDA’s Stein Says

Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.

Drug dose — The FDA touts selecting the optimal dose early in clinical development. • Source: Alamy

While there has been an increased focus on dose selection problems in oncology, the issue also occurs in other therapeutic areas and the US Food and Drug Administration will be paying closer attention at the investigational stage so sponsors are not forced to redo clinical trials.

Peter Stein, director of the US Food and Drug Administration’s Office of New Drugs, discussed the problem during a 14...