Vaccines and Diagnostics Trials

疫苗和诊断试验

• 批准号: 7558756
• 负责人: Joel I. Ward
• 金额: $ 21.41万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7558756
• 关键词: Biological Assay; Clinical; Clinical Research; Clinical Trials; Collaborations; Communicable Diseases; Conduct Clinical Trials; Consent; Consent Forms; Core Facility; Data Analyses; Data Collection; Diagnostic; Diagnostic Trial; Disease; Disease Outbreaks; Documentation; Elements; Emergency Situation; Emerging Communicable Diseases; Epidemiologic Studies; Evaluation; Faculty; Infectious Diseases Research; Investigation; Laboratories; Laboratory Study; Manuscripts; Medical center; Methods; Mission; Modality; Monitor; Personal Satisfaction; Pharmacoeconomic Study; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Population; Population Group; Population Study; Prevention; Procedures; Protocols documentation; Public Health; Reporting; Research Ethics Committees; Research Personnel; Research Proposals; Resources; Safety; Therapeutic; Training; Translational Research; Vaccine Research; Vaccines; Validation; Work; Writing; base; biodefense; data management; design; experience; instrument; novel diagnostics; pre-clinical; programs; prophylactic; research clinical testing; research study; response; validation studies

An essential element of a Regional Center of Excellence (RCE) for Biodefense and Emerging Infectious Disease Research proposal is the capacity to coordinate and conduct phase I and il clinical tirals as well as to conduct relevant popluation based epidemiologic studies and diagnostic validation studies. The UCLA Center for Vaccine Research has the expertise, experience, staffing, resources and facilities to conduct such clinical evaluations that will contribute to the RCE's mission for translational research. The specific aims for our core proposal include: 1) collaborate with RCE investigators to evaluate pre-clinical evaluations and develop clinical research plans, 2) develop and write protocols for phase I and phase II clinical evaiuatjons and epidemiologic studies, 3) develop relevant consent forms, regulatory documents, data collection instruments and procedures, 4) identify appropriate study populations, 5) conduct clinical trials, epidemiologic studies, and validation studies for new diagnostics, and 6) perform data collection and data analyses and prepare clinical reports and manuscripts.

生物防御和新兴领域区域卓越中心(RCE)的基本要素 传染病研究计划是协调和实施第一阶段和第二阶段的能力 临床试验以及进行相关的基于人口的流行病学研究和诊断 验证性研究。加州大学洛杉矶分校疫苗研究中心拥有专业知识、经验、人员配备、 进行此类临床评估的资源和设施，这将有助于RCE的任务 用于翻译研究。我们核心提案的具体目标包括：1)与RCE合作 研究人员评估临床前评估并制定临床研究计划，2)制定 和编写第一阶段和第二阶段临床评估和流行病学研究的方案，3) 制定相关同意书、规章文件、数据收集工具和程序； 4)确定适当的研究人群，5)进行临床试验、流行病学研究，以及 新诊断的验证研究，以及6)执行数据收集和数据分析以及 准备临床报告和手稿。