EO14042 DEVELOPMENT, STATISTICAL DESIGN, MONITORING AND COORDINATION OF VISION CLINICAL TRIALS AND EPIDEMIOLOGY RESEARCH

该合同旨在获得开发、设计、解释和评估临床试验、流行病学和自然历史研究的外部支持。此外，它将提供涉及眼病和视力障碍的结果研究和一些临床前研究。重点应放在研究的设计和收集、分析和解释来自这些研究的数据，以及支持、监测患者的安全性和随访。承包商还应如工作说明书中所述，为指定的临床研究数据库、成本效益和经济分析、生活质量评估和结果研究提供分析和数据管理支持。这将包括但不限于以下领域：对医疗保险和其他卫生保健数据库的分析；评估现有的NEI数据库，如集中的NEI校内研究数据库、眼病病例对照研究、早期治疗糖尿病视网膜病变研究、Framingham眼科研究和校内艾滋病和葡萄膜炎数据库。

This contract is designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies. In addition, it will provide for outcomes research involving eye diseases and visual disorders and some preclinical studies. The focus shall be on the design of studies and the collection, analysis, and interpretation of data emanating from these studies, as well as support, and monitoring patient safety and follow-up. Contractor shall also provide analytical and data management support, as described in the work statement, for specified clinical research data bases, cost-effectiveness and economic analyses, quality of life assessment and outcomes research. This will include, but not be limited to, the following areas: analysis of Medicare and other health care databases; evaluation of existing NEI databases such as, centralized NEI Intramural Research database, the Eye Disease Case Control Study, Early Treatment Diabetic Retinopathy Study, Framingham Eye Study, and intramural AIDS and uveitis databases.