Institute of Human Virology Clinical Trials Unit

人类病毒学研究所临床试验部

基本信息

批准号：
7096307
负责人：
WILLIAM Albert BLATTNER
金额：
$ 157.34万
依托单位：
UNIVERSITY OF MARYLAND BALTIMORE
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-02-01 至 2008-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7096307
关键词：
AIDS prevention Achievement Acquired Immunodeficiency Syndrome Address Adolescent Adult Affect Africa African African American Area Baltimore Caring Chemokine Receptor Gene Childhood Clinic Clinical Clinical Management Clinical Research Clinical Trials Commit Communication Communities Community Health Education Couples Data Quality Depth Emergency Situation End Point Enrollment Ensure Fruit Genetic Polymorphism HIV HIV Infections HIV vaccine Human Virology Infection Institutes International Intervention Intervention Studies Laboratories Leadership Learning Link Minority Morbidity - disease rate Mutation Nigeria Numbers Pediatric Research Persons Pharmaceutical Preparations Plant Roots Population Population Heterogeneity Prevention Prevention Research Prevention therapy Principal Investigator Procedures Process Public Health Rate Research Research Infrastructure Research Personnel Resources Risk Safety Site Standards of Weights and Measures Structure Suggestion Translational Research Vaccine Research Vaccines Virus Walkers Washington Woman Work base clinical research site cohort drug development efavirenz experience implementation trial mortality organizational structure programs research and development response volunteer

AIDS prevention Achievement Acquired Immunodeficiency Syndrome Address Adolescent Adult Affect Africa African African American Area Baltimore Caring Chemokine Receptor Gene Childhood Clinic Clinical Clinical Management Clinical Research Clinical Trials Commit Communication Communities Community Health Education Couples Data Quality Depth Emergency Situation End Point Enrollment Ensure Fruit Genetic Polymorphism HIV HIV Infections HIV vaccine Human Virology Infection Institutes International Intervention Intervention Studies Laboratories Leadership Learning Link Minority Morbidity - disease rate Mutation Nigeria Numbers Pediatric Research Persons Pharmaceutical Preparations Plant Roots Population Population Heterogeneity Prevention Prevention Research Prevention therapy Principal Investigator Procedures Process Public Health Rate Research Research Infrastructure Research Personnel Resources Risk Safety Site Standards of Weights and Measures Structure Suggestion Translational Research Vaccine Research Vaccines Virus Walkers Washington Woman Work base clinical research site cohort drug development efavirenz experience implementation trial mortality organizational structure programs research and development response volunteer

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项目摘要

DESCRIPTION (provided by applicant): The Institute of Human Virology Clinical Trials Unit (IHV-CTU) integrates five clinical research sites (CRS) four in the US (a Baltimore-Washington consortium) and one in Nigeria, West Africa that focus on four major research objectives: Drug Research and Development; Optimization of Clinical Management for adult, adolescent and pediatric populations; HIV Prevention; and Vaccine Research and Development. The IHVCTU leadership, PI, William A. Blattner, MD, Co-Pi Robert R. Redfield MD and Co-Pi John F. Farley MD direct specific research areas and articulate complementary strengths in a collaborative process guided by the IHV-CTU communication plan to implement trials of highest GCP standard. The IHV-Treatment CRS, [Site Leader (SL) Charles Davis MD], with a 4000 person clinic base, targets Drug development and Optimization of Clinical Management. The Chase Brexton CRS (SL Patrick McLeroth, MD) employs a community clinical base to undertake Optimization of Clinical Management research trials, as does the Whitman Walker CRS, whose SL is Philippe Chiliade, MD. The Project BRAVE CRS, (SL William A. Blattner MD) with deep roots in the Baltimore community, targets HIV vaccine research and development. The IHV Nigeria CRS, SL John F. Farley MD, exploits a substantial 10,000 plus PEPFAR (President's Emergency Program for AIDS Relief) treatment cohort, to undertake HIV prevention trials among HIV discordant couples at risk for HIV CRF_02 AG infection. The IHV-CTU harmonizes research practice through organizational structures and a communication plan that employs uniform standard operating procedures (SOP) across all CRS, and clinical management working groups that optimize research practice. An Executive Committee comprised of the PI and Co-Pi allocate and reallocate resources to adapt to emerging clinical trial priorities guided by the Investigators Committee that advance the most promising interventions by re-allocating CTU resources. CRS community engagement through community-active advisory boards (CAB) are linked through the IHV-CTU CAB to effect community education and recruitment that effectively engages underserved African American populations in trials research. Results of this clinical research impact the public health by advancing HIV treatment standards, developing a vaccine, and learning more effective approaches to HIV prevention. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：人类病毒学研究所临床试验部（IHV-CTU）在美国（巴尔的摩 - 华盛顿联盟）和西非的一个五个临床研究地点（CRS）整合了四个主要研究目标：药物研究和开发；优化成人，青少年和儿科人群的临床管理；预防艾滋病毒；和疫苗研发。 IHVCTU领导力PI，MD William A. Blattner，Co-Pi Robert R. Robert R. Redfield医学博士和Co-Pi John F. Farley MD直接特定的研究领域以及在IHV-CTU沟通计划中指导的协作过程中，以实施最高GCP标准的试验。 IHV处理CRS，[STER Leader（SL）Charles Davis MD]，拥有4000人的诊所基础，针对临床管理的药物开发和优化。 Chase Brexton CRS（SL Patrick McLeroth，MD）采用社区临床基础来优化临床管理研究试验，惠特曼·沃克CRS也是SL，其SL是Philippe Chiliade，MD。该项目在巴尔的摩社区中具有深层根源的勇敢的CRS（SL William A. Blattner MD）针对HIV疫苗研究与开发。 IHV尼日利亚 CRS，SL John F. Farley MD，利用了10,000多个PEPFAR（总统的艾滋病救济紧急计划）治疗队列，以在HIV CRF_02 AG感染风险的HIV不一致的夫妇中进行HIV预防试验。 IHV-CTU通过组织结构和沟通计划来协调研究实践，该计划在所有CRS中采用统一的标准操作程序（SOP）以及优化研究实践的临床管理工作组。由PI和CO-PI组成的执行委员会分配和重新分配资源，以适应由调查人员委员会指导的新兴临床试验优先级，该委员会通过重新分配CTU资源来推动最有希望的干预措施。通过社区活动咨询委员会（CAB）通过IHV-CTU CAB进行了社区参与，以实现社区教育和招聘，从而有效地吸引了不受欢迎的非洲裔美国人口在试验研究中。这项临床研究的结果通过提高艾滋病毒治疗标准，开发疫苗以及学习更有效的艾滋病毒预防方法来影响公共卫生。管理组件：