BRIEF—FDA issues guidance on designing cancer trials to support accelerated approval

The US Food and Drug Administration (FDA) has issued draft guidance on clinical trial design considerations to support accelerated approval applications.

This guidance discusses the design of trials, ways to improve the data available at the time of accelerated approval, and reduce uncertainty for patients by initiating post-marketing confirmatory studies in a timely manner.

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said: “The FDA’s accelerated approval program has provided patients with cancer earlier access to novel treatments that can be practice changing.

“Building quality and efficiency into the design of oncology clinical trials is a crucial component in providing maximum benefit to those living with cancer.”

The draft guidance is available here.