This application is submitted in response to the RFA for a Coordinating Center (CC) to serve the needs of the Diabetic Macular Edema Clinical Research Network. The network is expected to include 25 clinics, a Fundus Photograph Reading Center (FPRC), Study Chairman's Office, and a CC. The main objective of this network is to evaluate promising new treatment approaches for diabetic macular edema (DME). The role of the CC is critical for the success of a multi-center study. The importance to the network of having an experienced CC, particularly one with experience in eye disease trials, is sufficiently self-evident in the RFA that it needs no justification statements here. While the core principles followed by a CC in study protocol design, quality control, study conduct, and statistical analyses have changed little in the last 20 years, through technologic advances the approach to carrying out many CC functions has changed considerably. Advances in computing and in access to the Internet have provided new opportunities for a CC to enhance quality control measures and at the same time increase efficiency. This evolution in CC trial management will continue as technology continues to advance. For essentially all aspects of the project, we will draw upon our experience in our past and current studies. We have coordinated numerous multi-center eye disease investigator groups and have experience with all of the CC functions and responsibilities that will be part of this project. We have considerable experience with study groups conducting multiple, concurrent and consecutive protocols, a likely aspect of this project. We have been innovative in our approach to clinical trial conduct and management and have relied extensively on using the Internet to not only increase efficiency but also in many ways to enhance quality control measures. For a number of years we have worked to develop a data management system that is as generic as possible so a new study can be readily added to an existing data management structure. This extends to website development in which the web-based applications we have developed for our prior and current studies will serve as a template for this project. This proposal will detail the capabilities of the Jaeb Center to serve as the CC for the network and our plans to carry out the objectives of the project.
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