Putting the "e" in FDA's Draft PRO Guidance

The 2006 Guidance reveals the advantages of using electronic modalities, such as IVR, when collecting patient-reported data.

The FDA's draft guidance, "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims," marks a formal positioning of the agency's stance regarding patient reported outcomes (PROs) in clinical trials. In publishing its guidance, the FDA has implicitly acknowledged the role of PROs and does so explicitly with statements such as: "Patients provide a unique perspective on treatment effectiveness," "Some treatment effects are known only to the patient," "Self-completed questionnaires...are often preferable to the clinician administered interview and rating." In addition, much like the EMEA,1 the FDA has acknowledged the importance and advantages of the collection of electronic patient reported outcomes (ePRO).

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