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Going PRO: FDA Suggests Best Practices For Choosing, Changing Patient-Reported Outcome Tools

 
• By Shawn M. Schmitt

Patient-Reported Outcome (PRO) instruments are the focus of a 26 January final guidance from the US agency. Sponsors can lean on the guidance when selecting, developing or modifying tools for patient data collection.

Businessman holding gear icon with tools.
• Source: Alamy

The US Food and Drug Administration in a final guidance document has laid bare best practices sponsors can lean on when selecting, developing or modifying tools for patient data collection.

Those tools, called patient-reported outcome (PRO) instruments, collect “how patients feel, function and survive as valid scientific evidence to support the regulatory and health care decision-making process,” the FDA explains...

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