Leadership for HIV/AIDS Clinical Trials Networks; HIV Vaccine Trials Network

艾滋病毒/艾滋病临床试验网络的领导；

• 批准号: 7901059
• 负责人: STEVEN G. SELF
• 金额: $ 1234.71万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-29 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7901059
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adjuvant; Adolescent; Adult; Age; Antibodies; Antigens; Arts; Biological Assay; Case Report Form; Characteristics; Clinical; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collection; Combined Vaccines; Common Data Element; Communities; Community Health Education; Conduct Clinical Trials; Coordination and Collaboration; Data; Data Collection; Data Set; Development; Disease Progression; Dose; Effectiveness; Enrollment; Epidemic; Evaluation; Funding; Genetic; Genital system; Geographic Locations; Goals; Grant; Guidelines; HIV; HIV Infections; HIV Vaccine Trials Network; HIV vaccine; HIV-1; HIV-1 vaccine; Head; Home environment; Human; Immune response; Immunity; Immunology procedure; Individual; Infection; International; Laboratories; Laboratory Study; Leadership; Licensure; Lymphoid Tissue; Measurement; Mediating; Methodology; Mission; Monitor; Mucosal Immune Responses; Mucosal Immunity; Peripheral Blood Mononuclear Cell; Persons; Phase; Phase II Clinical Trials; Play; Population; Poxviridae; Prevention; Prevention Research; Preventive; Process; Protocols documentation; Publications; Qualifying; Randomized; Regimen; Reporting; Research; Retrieval; Risk; Risk Behaviors; Role; Route; Safety; Schedule; Security; Series; Site; Social Characteristics; Structure; Surface; System; T-Lymphocyte; Testing; Training; United States National Institutes of Health; Vaccination; Vaccine Research; Vaccines; Viral; Viremia; Woman; antiretroviral therapy; cost; cost effectiveness; data management; defective adenoviral vector; design; efficacy evaluation; efficacy trial; experience; falls; high risk; immunogenic; immunogenicity; improved; men; novel; operation; plasmid DNA; programs; public health priorities; response; standardize guidelines; statistical center; transmission process; vaccine candidate; vaccine effectiveness; vaccine efficacy; vector

This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Vaccine Trials Network (HVTN) is one of three applications comprising the Leadership Group of the HVTN. The HVTN scientific agenda focuses exclusively on RFA priority number 1: 'Vaccine Researchand Development." This application describes howthe Statistical Center for HIV/AIDS Research& Prevention (SCHARP) will achieve the aims of the RFAto (1) provide statistical leadership for the design, conduct, analysis and publication of Network clinical trials/studies; (2) provide central data management capability that includes randomization, data set and case report form design, central storage, security, processing and retrieval of study results; (3) provide data management and protocol training throughout the Network; (4) provide data-focused clinical trials implementation, and operation; and (5) contribute to cross-Network efforts in developing common data elements and data interfaces. SCHARP has extensive experience in the design, conduct and analysis of global HIV vaccine and prevention studies. Thus, the systems we propose to use for data collection, managment, monitoring, and analysis are all well tested and in accordance with ICH guidelines. SCHARP statisticians will also develop and deploy novel statistical methodologies to increase the efficiency and rigor of the proposed program of HlV vaccine trials. The HIV/AIDS epidemic continues to expand in almost all regions of the world, with approximately 4.8 million new infections in 2003 (UNAIDS 2004 Report on the Global AIDS Epidemic). Finding a safe, effective vaccine that will protect persons against infection and/or disease progression is an international public- health priority. Only through clinical trials held to the highest scientific and regulatory standards willthis goal be achieved.

该应用程序继续作为HIV疫苗的统计和数据管理中心（SDMC） 试验网络（HVTN）是包括HVTN领导力小组的三个应用程序之一。这 HVTN科学议程仅关注RFA优先级1：'疫苗研究和 开发。 （Scharp）将实现RFATO（1）的目标（1）为设计，行为， 分析和发布网络临床试验/研究； （2）提供中央数据管理功能 其中包括随机化，数据集和案例报告表格设计，中央存储，安全性，处理和 检索研究结果； （3）在整个网络中提供数据管理和协议培训； （4） 提供以数据为重点的临床试验实施和操作； （5）有助于跨网络 开发常见数据元素和数据界面的努力。 Scharp在全球HIV疫苗的设计，行为和分析方面具有丰富的经验 预防研究。因此，我们建议用于数据收集，管理，监视和 分析都经过了很好的测试，并且符合ICH指南。 Scharp统计学家也将发展 并部署新颖的统计方法，以提高拟议计划的效率和严格 HLV疫苗试验。 艾滋病毒/艾滋病流行在世界上几乎所有地区都在扩展，约为4.8 2003年有百万个新感染（UNAID 2004年全球艾滋病流行报告）。找到安全，有效的 可以保护人免受感染和/或疾病进展的疫苗是国际公共 健康优先级。只有通过达到最高科学和法规标准的临床试验才能实现目标 实现。