The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving oncology clinical trials for accelerated approval.
The guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, is regarding the design of clinical trials.
It also discusses ways to improve the data available for accelerated approval and reduce uncertainty for patients by commencing post marketing confirmatory trials in a timely manner.
The draft guidance specifically addresses the design, conduct and analysis of data with two randomised clinical trial approaches. These include conducting two different randomised controlled clinical trials or using one for both accelerated approval and for verifying the clinical benefit.
It also offers considerations for sponsors for determining the adequacy of single arm trials to support an application.
Post-marketing confirmatory trials are also required for verifying and describing the expected clinical benefit, for drugs which were granted accelerated approval.
US FDA Oncology Center of Excellence director Richard Pazdur said: “The FDA’s accelerated approval programme has provided patients with cancer earlier access to novel treatments that can be practice changing.
“Today’s draft guidance provides recommendations to sponsors for designing clinical trials to support accelerated approval.
“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 regulator noted that the new guidance highlights that use of the one-trial approach, in appropriate cases, may not need separate trials as a long-term follow-up in the same study could fulfil a post-marketing requirement for verifying the clinical benefit.
