Vaccines and Diagnostics Trials

疫苗和诊断试验

• 批准号: 7632160
• 负责人: Joel I. Ward
• 金额: $ 21.85万
• 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/7632160
• 关键词: Clinical; Clinical Research; Clinical Trials; Collaborations; Conduct Clinical Trials; Consent; Consent Forms; Core Facility; Data Analyses; Data Collection; Diagnostic; Diagnostic Trial; Disease Outbreaks; Documentation; Elements; Emerging Communicable Diseases; Epidemiologic Studies; Evaluation; Infectious Diseases Research; Investigation; Manuscripts; Mission; Personal Satisfaction; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Population; Population Study; Procedures; Protocols documentation; Reporting; Research Personnel; Research Proposals; Resources; Translational Research; Vaccine Research; Vaccines; Validation; Work; Writing; base; biodefense; experience; instrument; novel diagnostics; pre-clinical; research clinical testing; research study; 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卓越区域中心（RCE）的重要组成部分