Diabetic Macular Edema Clinical Research Network

描述(由申请者提供)：本申请是为了响应RFA为糖尿病黄斑水肿临床研究网络建立协调中心(CC)的需要而提交的。该网络预计将包括25个诊所、一个眼底照片阅读中心(FPRC)、研究主席办公室和一个CC。该网络的主要目标是评估有前景的治疗糖尿病黄斑水肿(DME)的新方法。 CC的作用对于一项多中心研究的成功至关重要。拥有一名经验丰富的CC对网络的重要性，特别是一名具有眼病试验经验的CC，在RFA中是足够不言而喻的，它在这里不需要理由陈述。虽然CC在研究方案设计、质量控制、研究进行和统计分析中遵循的核心原则在过去20年中几乎没有变化，但通过技术进步，执行CC许多功能的方法已经发生了很大变化。计算和互联网接入方面的进步为协调委员会提供了新的机会，以加强质量控制措施，同时提高效率。随着技术的不断进步，CC试验管理的这种演变将继续下去。 基本上，对于该项目的所有方面，我们都将借鉴我们过去和现在研究中的经验。我们已经协调了许多多中心眼病研究小组，并拥有作为该项目一部分的CC的所有职能和职责的经验。我们在研究小组进行多个、同时和连续的方案方面有相当多的经验，这可能是这个项目的一个方面。我们在临床试验进行和管理方面一直在创新，并广泛依赖互联网不仅提高了效率，而且在许多方面加强了质量控制措施。多年来，我们一直致力于开发一个尽可能通用的数据管理系统，以便可以很容易地将新的研究添加到现有的数据管理结构中。这延伸到网站开发，在网站开发中，我们为以前和目前的研究开发的基于网络的应用程序将作为该项目的模板。该提案将详细说明Jaeb中心作为网络CC的能力以及我们实现项目目标的计划。

DESCRIPTION (provided by applicant): 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.