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.


  • Definitions and terminology of patient-reported outcomes relevant to medical product development
  • Background: Importance of patient-reported outcomes within different perspectives of ophthalmology
  • What is known and what else do we need to know about patient-reported outcomes in ophthalmology
  • Development and validation issues
  • Clinical trial design issues relevant to patient-reported outcomes intended to support medical product labeling
  • What are some clinically meaningful challenges in this field?
  • Discussion with faculty and attendees: Where do we go from here?

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 to download the full agenda, including faculty, and to register.

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