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

EO14042 视力临床试验和流行病学研究的开发、统计设计、监测和协调

• 批准号: 10788128
• 负责人: SUPRIYA MENEZES
• 金额: $ 690.8万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2023-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788128
• 关键词: Acquired Immunodeficiency Syndrome; Age related macular degeneration; Anophthalmos; Area; Autologous Transplantation; Bilateral; Case/Control Studies; Cell Line; Clinical; Clinical Research; Clinical Trials; Cognition; Collection; Coloboma; Contractor; Contracts; Cost Analysis; Cross-Sectional Studies; DNA Repository; Dark Adaptation; Data Analyses; Databases; Development; Diabetic Retinopathy; Diagnosis; Disease; Early treatment; Electrooculogram; Eligibility Determination; Epidemiology; Esthesia; Evaluation; Evaluation Studies; Extramural Activities; Eye; Eye diseases; Family; Follow-Up Studies; Gene Transfer; Generations; Genes; Genetic; Genotype; Healthcare; Human; Inflammation Mediators; Inflammatory; Inherited; Intramural Research; Investigation; Longterm Follow-up; Measures; Mediating; Medicare; Metformin; Microglia; Microphthalmos; Minocycline; Molecular; Monitor; Mutation; Natural History; Oral; Outcome; Outcome Measure; Outcomes Research; Participant; Pathogenesis; Patient Monitoring; Patients; Perception; Phase; Phenotype; Pilot Projects; Proteome; Quality of Life Assessment; Randomized; Research; Retinal Diseases; Retinal Vein Occlusion; Retinitis Pigmentosa; Safety; Secondary to; Somatic Cell; Specific qualifier value; Stargardt' s disease; Structure of retinal pigment epithelium; Supplementation; Surveys; Telangiectasis; Testing; Type 7 Spinocerebellar Ataxia; Uveitis; Vertebrate Photoreceptors; Vision; Vision Disorders; Visual Motor Coordinations; Work; X-Linked Retinoschisis; active method; adaptive optics; age related; biobank; central retinal vein occlusion; clinical epidemiology; data management; design; disorder of macula of retina; economic evaluation; effectiveness analysis; epidemiology study; exome; follow-up; genome sequencing; geographic atrophy; induced pluripotent stem cell; inhibitor; macula; microbiome; open label; optical imaging; participant enrollment; patient safety; phase I/IIa trial; preclinical study; prospective; retinal imaging; retinal toxicity; retinyl palmitate; safety study; virtual reality; whole genome

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.

该合同旨在获得开发，设计，解释和评估临床试验，流行病学和自然史研究的校外支持。此外，它将提供涉及眼科疾病和视觉障碍的结果研究以及一些临床前研究。重点应放在研究的设计和收集，分析和解释这些研究产生的数据，以及支持和监测患者的安全性和随访。承包商还应提供工作说明书中所述的分析和数据管理支持，用于指定的临床研究数据库、成本效益和经济分析、生活质量评估和结局研究。这将包括但不限于以下领域：医疗保险和其他医疗保健数据库的分析;现有NEI数据库的评估，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，Fracket Eye研究，以及校内艾滋病和葡萄膜炎数据库。