Grasping the FDA's PRO Guidance

Patient reported outcomes (PROs) are data obtained directly from patient self-reports, and their use in clinical trials is increasingly common.1 The U.S. Food and Drug Administration (FDA) recently published for comment their "Patient Reported Outcome (PRO) Measures: Use in Medical Product Development to Support Labeling Claims,"2 hereafter referred to as the PRO Guidance, to describe how they will evaluate PRO instruments. The PRO Guidance lays out the type and quality of information that clinical researchers will need to provide to justify the use of a particular PRO instrument in a trial and highlights the significance of PRO data in drug development.

By setting ground rules for use of PROs, the FDA has implicitly given credibility to PROs as the basis for evaluating drugs and biologics. Further, such guidance will eventually make for more efficient, effective, and appropriate use of these tools.

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