Use of Patient-Reported Outcomes in Medical Product Development: A Report from the 2009 NEI/FDA Clinical Trial Endpoints Symposium

Abstract

, the third in a series of meetings to discuss endpoints in ophthalmic clinical trials was held at the National Institutes of Health (NIH). This event, about patientreported outcomes (PROs), was an opportunity for the vision community and the U.S. Food and Drug Administration (FDA) to meet and discuss the FDA requirements for adding new endpoints to the evaluation of ophthalmic treatments and products. The meeting was attended by researchers, clinicians, policymakers, and representatives from industry and vision associations. The first two meetings, in 2006 and 2008, were held to discuss endpoints and clinical trial strategies for evaluating new treatments for age-related macular degeneration (AMD) and diabetic retinopathy and glaucoma treatments, respectively. he objectives of this conference were to provide definitions of PROs, to describe the importance of PROs, to assess what is known and what should be known about PROs in ophthalmology, to provide insights on how the FDA evaluates development and validation of PRO instruments, and to report on clinical trial design issues relevant to PROs.