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Glaucoma Clinical Research in the Community Setting

  • Harvey DuBiner
  • Helen DuBiner
  • Paul N. Schacknow
Chapter

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.

Keywords

Principal Investigator Study Coordinator Clinical Research Trial Clinical Trial Protocol Federal Drug Administration 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Harvey DuBiner
    • 1
  • Helen DuBiner
    • 2
  • Paul N. Schacknow
    • 3
    • 4
  1. 1.Clayton Eye CenterMorrowUSA
  2. 2.Clayton Eye Center, Clinical Study CoordinatorMorrowUSA
  3. 3.Division of OphthalmologyNova Southeastern UniversityFort LauderdaleUSA
  4. 4.Visual Health CenterPalm SpringsUSA

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