skip navigation

S M L Text size

Archived Page

The information on this page is archived and provided for reference purposes only. It was current when it was produced, but may now be out-of-date. Persons having difficulty accessing this information may contact kcl@nei.nih.gov for assistance. For reliable, current information on this and other topics, we recommend that you visit the National Eye Institute website index.

Home » News and Events » Use of Patient-reported Outcomes in Medical Product Development

News and Events

NEI/FDA Endpoints Symposium

Use of Patient-reported Outcomes in Medical Product Development

October 13, 2009
Lister Hill, National Institutes of Health, Bethesda, MD

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.

Program

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, 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 refractive surgery, cataract surgery, glaucoma and retina. FDA representatives will present insights about how the FDA reviews and evaluates patient-reported outcome instruments, while industry representatives will talk about the specific issues involved in developing instruments, ophthalmic drugs and biologics.

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.



Department of Health and Human Services NIH, the National Institutes of Health USA.gov