Penn prevention clinical trials unit

描述（由申请人提供）： 在本申请中，我们建议成立宾夕法尼亚大学预防临床试验部门。在成功参与NIAID资助的网络（项目启动，HIVNET和HPTN）的12年历史的基础上，我们正在申请与三个拟议的领导小组合作：疫苗，HPTN和杀微生物剂。为了反映与现有网络的这种联系，我们正在提交三项正在进行的NIAID申办的临床试验的过渡预算：HPTN 037（HPTN）; HPTN 035（MTCT）;和HVTN（502）作为本申请的组成部分。 PENN预防CTU的研究团队包括在地方，国家和国际层面具有悠久合作历史和科学贡献的研究人员。研究者曾在HIVNET科学指导委员会（成员）、HPTN方案审查委员会（成员）和HPTN物质使用工作组（主席）担任领导职务。我们的研究中心被列为我们寻求的三个网络中的首选研究中心，研究人员也被列为两个拟议领导小组申请（杀微生物剂和HPTN）的关键人员。 PENN预防CTU将与PENN治疗CTU（ACTG）和CHOP CTU（IMPACT）完全整合。我们将扩大目前与这些CTU的研究者的合作，并开发组织结构，以提高网络和CTU的效率，包括使用共享的实验室、药房、培训和QA/QC资源。科学顾问委员会将我们的CTU连接到校园内可用的科学专业知识。 费城的艾滋病流行为开展预防科学提供了重要机会。我们的网站继续制定旨在接触高危人群的战略，以促进完成三个网络的拟议科学议程。我们建议在乌克兰建立一个临床研究中心，研究团队在招募高发病率队列方面有着令人印象深刻的记录。 预防社区咨询委员会自1993年以来每月举行一次会议。 CAB的成员通过开展社区和参与者教育活动以及在众多礼宾团队中提供服务，参与预防研究的历史悠久。 行政部门：

DESCRIPTION (provided by applicant): In this application we propose the establishment of the University of Pennsylvania Prevention Clinical Trials Unit. Building upon a 12 year history of successful involvement in NIAID funded Networks (Project Jumpstart, HIVNET, and HPTN) we are applying for collaborations with three of the proposed leadership groups: Vaccines, HPTN, and Microbicides. Reflecting this connection to existing networks we are submitting transition budgets for three ongoing NIAID sponsored clinical trials: HPTN 037 (HPTN); HPTN035 (MTCT); and HVTN (502) as a component of this application. The research team of the PENN Prevention CTU includes investigators with a long history of collaboration and scientific contribution at the local, national and international level. Investigators have served in leadership positions on the HIVNET Scientific Steering Committee (member), the HPTN Protocol Review Committee (member), and the HPTN Substance Use Working Group (Chair). Our site is listed as a preferred site in each of the three networks with which we seek Investigators are also listed key personnel in two of the proposed leadership group applications (Microbicides and HPTN). The PENN Prevention CTU will be fully integrated with the PENN Therapeutics CTU (ACTG) and the CHOP CTU (IMPACT). We will expand our current collaborations with investigators from these CTUs and have developed organizational structures that will result in efficiencies across Networks and CTUs including the use of shared laboratory, pharmacy, training, and QA/QC resources. A Scientific Advisory Board will connect our CTUs to the scientific expertise available on campus. The HIV epidemic in Philadelphia provides an important opportunity to conduct prevention science. Our site continues to develop strategies designed to access high risk populations necessary to contribute to the completion of the proposed scientific agendas of the three networks. We are proposing a Clinical Research Site in the Ukraine where the study team has an impressive record of recruiting high incidence cohorts. The Prevention Community Advisory Board (CAB) has been meeting on a monthly basis since 1993. Members of this CAB have a long history of participation in prevention research through the conduct of community and participant education initiatives and service on numerous protocol teams. ADMINISTRATIVE COMPONENT: