Public Release: 

Use of patient-reported outcomes in medical product development

NEI/FDA Endpoints Symposium

Association for Research in Vision and Ophthalmology

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.

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

This meeting is being managed by the Association for Research in Vision and Ophthalmology.

About the Association for Research in Vision and Ophthalomology

ARVO is the largest eye and vision research organization in the world. Members include more than 12,500 eye and vision researchers from over 80 countries. The Association encourages and assists research, training, publication and dissemination of knowledge in vision and ophthalmology. Visit www.arvo.org.

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