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

基本信息

批准号：
10722807
负责人：
SUPRIYA MENEZES
金额：
$ 688.21万
依托单位：
THE EMMES COMPANY, LLC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-10-28 至 2022-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10722807
关键词：
Acquired Immunodeficiency Syndrome Age related macular degeneration Anophthalmos Area Analyses Autologous Transplantation Bilateral Case-Control Studies Cell Line Clinical Clinical Research Clinical Trials Cognition Collection Coloboma Contractor Contracts Cost Effectiveness Analysis Cross-Sectional Studies DNA Repository Dark Adaptation Data Analyses Databases Development Diabetic Retinopathy Diagnosis Disease Early treatment Electrooculogram Eligibility Determination Enrollment 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 Institutes 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 Retina Retinal Diseases Retinal Vein Occlusion Retinitis Pigmentosa Safety Secondary to Somatic Cell Specific qualifier value Structure of retinal pigment epithelium Supplementation Surveys Telangiectasis Testing Toxic effect 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 epidemiology study exome follow-up genome sequencing geographic atrophy induced pluripotent stem cell inhibitor macula macular dystrophy microbiome open label optical imaging patient safety preclinical study prospective retinal imaging retinyl palmitate safety study sham-controlled study virtual reality whole genome

项目摘要

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壁外支持。此外，它将提供涉及眼部疾病和视觉疾病以及一些临床前研究的结果研究。重点应放在研究的设计以及从这些研究中发出的数据的收集，分析和解释，以及支持以及监测患者的安全和随访。正如工作声明中所述，承包商还应为特定的临床研究数据库，成本效益和经济分析，生活质量评估和成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：Medicare和其他医疗保健数据库的分析；评估现有的NEI数据库，例如集中式NEI NEI研究数据库，眼病病例对照研究，早期治疗糖尿病性视网膜病变研究，Framingham Eye研究以及壁内艾滋病和葡萄膜炎数据库。