Glaucoma clinical research in the community setting

Abstract

While medical scientists at both universities and pharmaceutical companies may discover and develop suitable drug candidates to treat glaucoma, the US Federal Drug Administration (FDA) requires that such medications be tested on human patients during structured clinical trials before the drugs may be approved and prescribed by physicians. The clinical research that leads to the approval of the medications we use daily to treat our glaucoma patients takes place not only in industry-sponsored laboratories but also in academic centers and community-based office practices. Indeed, community-based ophthalmology practices provide a large proportion of the patients who enroll in clinical trials, especially at later stages of development. This chapter will describe how such clinical trials are incorporated into a busy ophthalmology practice in the United States. Here, we will limit our discussion to medical glaucoma research trials. The approval process is structured differently for research into surgical devices such as glaucoma shunts. © 2010 Springer-Verlag New York.