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

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...