Use of patient-reported outcomes in medical product development

The National Eye Institute (NEI) and the Food and Drug Administration (FDA) are sponsoring an October 13 conference to determine how vision-related patient-reported outcomes might be used to improve medical product labeling in ophthalmology.

Patient-reported outcomes are being incorporated more frequently into randomized clinical trials. A growing body of evidence strongly suggests that such patient-reported outcomes are key to providing a better understanding of treatment outcomes, beyond the data obtained from visual acuity or visual field measurements. The FDA is already incorporating this type of patient-reported information into medical product labeling in areas outside ophthalmology.

This meeting, part of an NEI/FDA series of Endpoints Symposia managed by the Association for Research in Vision and Ophthalmology (ARVO), will explore the issues and challenges related to patient-reported information in ophthalmology. Participants will also look at FDA guidelines for using patient-reported outcomes and how they are incorporated for medical devices and drugs.

Faculty will include authorities in instrument development, refractive surgery, cataract surgery, glaucoma and retina. FDA representatives will present insights about how the FDA reviews and evaluates patient-reported outcome in support of product labeling for instruments and ophthalmic drugs and biologics.

Visit www.arvo.org/endpoints09 to download the full agenda, including faculty, and to register.

Source: Association for Research in Vision and Ophthalmology