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Opioid-Sparing Claims May Be Better Suited For Phase IV Trials Instead Of Phase III

 
• By Michael Cipriano

US FDA advisory committee panelists argue that prospective, randomized Phase III trials fail to reflect real-world treatment decisions.

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Members of a US FDA advisory panel opined that traditional Phase III studies are not sufficient to support opioid-sparing claims, and that Phase IV postmarketing studies are better equipped for such a purpose. 

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