Penn prevention clinical trials unit

在这份申请中，我们建议建立宾夕法尼亚大学预防临床试验股。在成功参与NIAID资助的网络(JumpStart项目、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和杀菌剂。为了反映这种与现有网络的联系，我们提交了NIAID赞助的三项正在进行的临床试验的过渡预算：HPTN 037(HPTN)；HPTN035(MTCT)；以及HVTN(502)，作为本申请的一个组成部分。 宾夕法尼亚大学预防CTU的研究团队包括在地方、国家和国际层面有着长期合作和科学贡献的研究人员。调查人员曾在HIVNET科学指导委员会(成员)、HPTN议定书审查委员会(成员)和HPTN物质使用工作组(主席)担任领导职务。我们的网站在我们寻求的三个网络中都被列为首选网站，调查人员也被列为拟议领导小组应用程序(杀菌剂和HPTN)中的两个关键人员。 宾夕法尼亚大学预防CTU将与宾夕法尼亚大学治疗CTU(ACTG)和CHOP CTU(IMPACT)完全整合。我们将扩大目前与来自这些CTU的研究人员的合作，并已开发出将在网络和CTU之间产生效率的组织结构，包括使用共享的实验室、药房、培训和QA/QC资源。一个科学咨询委员会将把我们的CTU与校园内现有的科学专业知识联系起来。 费城的艾滋病毒流行为开展预防科学提供了一个重要机会。我们的网站继续制定战略，以便接触到必要的高危人群，以促进完成三个网络拟议的科学议程。我们建议在乌克兰建立一个临床研究站点，在那里研究团队在招募高发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。这一委员会的成员通过开展社区和参与者教育倡议以及在许多礼宾小组提供服务，参与预防研究的历史由来已久。

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.