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US FDA Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval

 
• By Derrick Gingery

Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.

Neurology lab
OCE guidance says one or two randomized controlled trials could be sufficient to receive accelerated approval and confirm clinical benefit. • Source: Shutterstock

New accelerated approval draft guidance for oncology drugs largely formalizes podium policy that US Food and Drug Administration officials have given in recent months, including strongly recommending randomized clinical trials over single-arm studies.

The guidance, issued on 24 March, states that while single-arm trials may be appropriate in some settings, they can...

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