Diabetic Retinopathy Clinical Research Network Operations Center

糖尿病视网膜病变临床研究网络运营中心

• 批准号: 7938634
• 负责人: Neil Michael Bressler
• 金额: $ 15.34万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7938634
• 关键词: Adherence; Adverse event; Ancillary Study; Applications Grants; Automatic Data Processing; Blindness; Budgets; Certification; Clinical Research; Clinical Trials; Code; Collaborations; Communication; Communities; Concept Review; Conflict of Interest; Consent Forms; Data; Data Collection; Dedications; Development; Diabetic Retinopathy; Disease; Educational workshop; Enrollment; Fellowship; Foundations; Freedom; Funding; Future; Goals; Grant; Guidelines; Human Resources; Image; Image Analysis; Impairment; Individual; Industry; Industry Collaboration; Insulin-Dependent Diabetes Mellitus; International; Investigation; Leadership; Manuals; Manuscripts; Mediation; Medical; Mentors; Methodology; Methods; Minor; Monitor; Newsletter; Ophthalmology; Performance; Pharmaceutical Preparations; Phase; Policies; Principal Investigator; Procedures; Process; Protocols documentation; Quality Control; Reading; Reporting; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Resources; Retina; Retinal; Review Committee; Role; Safety; Site; Site Visit; Specialist; Specific qualifier value; Staging; Teleconferences; Third-Party Payer; Time; Training; Training Support; United States; United States National Institutes of Health; Universities; Vision; Visual Acuity; Writing; base; clinical research site; community based practice; cost; diabetic; electronic data; financial conflict of interest; interest; macular edema; meetings; member; minority subjects; operation; organizational structure; primary outcome; programs; protocol development; working group

DESCRIPTION (provided by applicant): The objective of the Diabetic Retinopathy Clinical Research Network (DRCR.net) is to develop and maintain a collaborative network to facilitate multicenter clinical research on diabetic retinopathy, diabetic macular edema and associated conditions, leading and growing causes of vision impairment and blindness in the United States and throughout the world. Its priorities include involvement of community-based practices as well as university-based centers and to collaborate with industry to facilitate investigations and opportunities otherwise not possible, but to do so in a manner consistent with the Network's dedication to academic integrity and optimal clinical trial performance. During the next funding cycle, the Network proposes to complete 5 protocols that are expected to be in progress at the time the funding period begins, initiate approximately 10 new protocols, develop and implement new methods for electronic data capture of retinal images to facilitate the conduct of diabetic retinopathy clinical trials, continue to expand the DRCR.net by soliciting the participation of new sites and encouraging the involvement of investigators who recently have completed fellowship training, continue to educate the DRCR.net investigators on the principles of clinical research, and mentor selected retina specialists to be leaders in clinical trials. The Network's Operations Center (OC) specific aims are to be responsible for the scientific oversight of protocol development. It also advises on procedures for subject enrollment; provides input to statistical analysis plans; assists the Network's Coordinating Center (CC) with protocol-specific recruitment enhancement plans and protocol- specific closeout plans; oversees members responsible for most Network manuscripts, presentations, ancillary studies, financial conflicts of interest, quality control, and protocol concepts; coordinates most Network committees, meetings, and teleconferences (e.g., setting up agendas, arranging and providing minutes for teleconferences and meetings); provides infrastructure for the Network Chair and Protocol Chairs; collaborates with outside entities (industry, FDA, foundations, other networks); certifies visual acuity examiners; and provides expertise regarding retina image acquisition and retina image analysis. Many of these activities have transferred from the CC to the office of the Network Chair since 2006. This application centralizes these activities during the next 5 years within the Network's Operations Center at Johns Hopkins.

描述（由申请人提供）：糖尿病视网膜病变临床研究网络（DRCR.net）的目标是开发和维护一个协作网络，以促进糖尿病视网膜病变、糖尿病黄斑水肿和相关疾病的多中心临床研究，这些疾病是美国和世界各地视力损害和失明的主要和不断增长的原因。它的优先事项包括以社区为基础的做法以及大学为基础的中心的参与，并与行业合作，以促进调查和机会，否则是不可能的，但这样做的方式符合网络的学术诚信和最佳临床试验性能的奉献精神。在下一个供资周期，该网络建议完成5项在供资期开始时预计正在进行的协议，启动大约10项新协议，开发和实施视网膜图像电子数据采集的新方法，以促进糖尿病视网膜病变临床试验的开展，继续扩大DRCR.net，征求新网站的参与，鼓励最近完成奖学金培训的研究人员继续教育DRCR.net研究人员临床研究的原则，并指导选定的视网膜专家成为临床试验的领导者。该网络的运营中心（OC）的具体目标是负责对协议制定进行科学监督。它还就受试者入组程序提供建议;为统计分析计划提供输入;协助网络协调中心（CC）制定方案特定的招募增强计划和方案特定的收尾计划;监督负责大多数网络手稿、演示文稿、辅助研究、财务利益冲突、质量控制和方案概念的成员;协调大多数网络委员会、会议和电话会议（例如，设立议程、安排和提供电话会议和会议记录）;为网络主席和协议主席提供基础设施;与外部实体（行业、FDA、基金会、其他网络）合作;认证视力检查员;并提供视网膜图像采集和视网膜图像分析方面的专业知识。自2006年以来，其中许多活动已从协调委员会转移到网络主席办公室。该应用程序将在未来5年内将这些活动集中在约翰霍普金斯的网络运营中心内。