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FDA Recommends Collaboration, Parallel Development Of Patient-Reported Outcome Tools

 
• By Elizabeth Orr

A new draft guidance document from the US agency on the development of instruments to measure patient-reported outcomes offers a range of approaches to improve the efficiency and quality of these important tools.

Doctor woman sitting with male patient at the desk

Is your company working on a new instrument to measure patient-reported outcomes as part of a device trial? Then it might want to collaborate with patient groups or health professional associations as part of the development process, the US Food and Drug Administration recommends in a new draft guidance document.

The guidance, dated 31 August, offers the agency’s views on selecting, developing and adapting patient-reported outcome (PRO) instruments for use in medical device evaluation. Among other recommendations, it suggests instrument...

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