Screening Study for the Evaluation and Diagnosis of Research Participants
Screening Study for the Evaluation and Diagnosis of Research Participants
批准号:
8075869
负责人:
DARBY THOMPSON
金额:
$0.66万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2006
资助国家:
美国
项目状态:
已结题
起止时间:
2006-11-01 至 2011-10-31
关键词:
Acquired Immunodeficiency SyndromeAgeArea AnalysesCase-Control StudiesClinical ResearchClinical TrialsCollectionContractorContractsDataDatabasesDiabetic RetinopathyDiagnosisEarly treatmentEconomicsEpidemiologyEvaluationEvaluation StudiesExtramural ActivitiesEyeEye diseasesHealthcareHereditary DiseaseInflammatoryIntramural ResearchMedicareMonitorNational Eye InstituteNatural HistoryOcular Motility DisordersOutcomes ResearchParticipantQuality-of-Life AssessmentResearchResearch DesignRetinal DiseasesScreening procedureSpecific qualifier valueUveitisVision DisordersWorkcost effectivenessdata managementdesigndiagnosis evaluationfollow-uppatient safetypreclinical studyresearch study
中文摘要
临床方案支持合同旨在获得开发,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。
临床方案的目的:
这项研究将使国家眼科研究所(NEI)的医生有机会检查患有眼疾的人,无论诊断是否已知,以确定他们是否有资格参加其他NEI研究。本研究未提供治疗。
患有各种眼部疾病的所有年龄段的人,包括遗传性疾病,眼运动障碍,炎症性眼病,视网膜疾病和外部眼病,都有资格参加这项研究。
英文摘要
Clinical Protocol support contract 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.
Objective of Clinical Protocol:
This study will allow National Eye Institute (NEI) doctors the opportunity to examine people with eye disease, whether the diagnosis is known or not, to determine if they are eligible for other NEI research studies. No treatment is offered in this study.
People of all ages with various eye conditions, including genetic conditions, eye movement disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be eligible for this study.
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会议论文
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