HIV PREVENTION TRIALS NETWORK LEADERSHIP GROUP

作为拟议的艾滋病毒预防试验网络(HPTN)的统计和数据管理中心(SDMC)的申请是由弗雷德·哈钦森癌症研究中心(FHCRC)响应国家过敏和传染病研究所(NIAID)RFA：AI-98-015，HPTN领导小组提交的。华盛顿大学公共卫生和社区医学院生物统计系将是FHCRC的联合申请者和分包商。该SDMC应用程序是由艾滋病毒预防试验网络(HPTN)领导小组组成的三个组件应用程序的一个组件。不同的申请描述了核心申请者，家庭健康国际公司，小威拉德·凯茨博士，派，以及中央实验室申请者约翰·霍普金斯大学，布鲁克斯博士，派。这一新网络的关键科学领导部分的组织情况见第1节，包括执行委员会、预防领导小组、外部咨询委员会、科学工作组和议定书审查委员会的成员。核心应用程序包含HPTN计划如何执行其科学议程的详细说明。该应用程序利用了FHCRC和UW提供的特殊优势。FHCRC有几个大型统计和数据管理协调中心，用于多站点和多方案试验小组。威斯康星大学的教师在艾滋病毒/艾滋病和性传播疾病的研究方面拥有丰富的生物统计学、流行病学和临床经验，并在进行临床试验方面拥有丰富的经验。赛尔夫博士和弗莱明博士在这两个机构都有教职任命(赛尔夫博士是FHCRC生物统计项目的负责人，弗莱明博士是威斯康星大学生物统计系的主任)，他们是黄博士和理查森博士。自1972年FHCRC成立以来，两个机构之间一直存在着牢固的联系，几乎所有FHCRC教职员工和许多UW教职员工都是联合任命的，因此，从学术角度来看，他们可以被视为同一个机构。本申请首先介绍有关艾滋病毒流行和预防工作的一般背景说明，无论是正在进行的还是拟议的。为减少病毒传播的各种方式，申请的其余部分由国家预防和预防中心负责，该中心在很大程度上借鉴了自1994年以来担任艾滋病毒预防试验网络统计中心的经验。将介绍从HIVNET向HPTN的过渡，以及将带入HPTN的程序和组织结构，以及将对其进行修改以加强SDMC目标的程序和组织结构。

This application to be the Statistical and Data Management Center (SDMC) for the proposed HIV Prevention Trials Network (HPTN) is submitted by the Fred Hutchinson Cancer Research Center (FHCRC) in response to the National Institute of Allergy and Infectious Disease (NIAID) RFA:AI-98-015, HPTN Leadership Group. The University of Washington, School of Public Health and Community Medicine, Department of Biostatistics will be a co-applicant and sub-contractor to the FHCRC. This SDMC application is one component of a three component application comprising the Leadership Group of the HIV Prevention Trials Network (HPTN). Separate applications describe the CORE applicant, Family Health International, Inc., Dr. Willard Cates Jr., PI, and the Central Laboratory applicant Johns Hopkins University, Dr. Brooks, PI. The organization of the key scientific leadership components of this new network is shown in Section 1 and includes the members of the Executive Committee, Prevention Leadership Group, External Advisory Committee, Scientific Working Groups and Protocol Review Committee. The Core application contains a detailed description of how the HPTN proposes to carry out its scientific agenda. This application takes advantage of the particular strengths provided by both the FHCRC and UW. The FHCRC has several large statistical and data management coordinating centers for multi-site and multi-protocol trial groups. The UW faculty has extensive biostatistical, epidemiological and clinical experience in research in HIV/AIDS and sexually transmitted diseases as well as considerable experience in conducting clinical trials. Drs. Self and Fleming have faculty appointments at both institutions (Dr. Self is Head of the Biostatistics Program at the FHCRC and Dr. Fleming serves as Chairman of the Department of Biostatistics at the UW), AS Drs. Huang and Richardson. With the strong ties that have existed between the two institutions since the FHCRC's establishment in 1972, virtually all FHCRC faculty and many UW faculty hold joint appointments, and thus, from an academic perspective, they can be regard as the same institution. This application begins with a general background statement relating to the HIV epidemic and prevention efforts, both underway and proposed, to reduce the various modes of viral transmission, The balance of the application is specific to the SDMC which, in large measure, draws upon the experience of serving as the Statistical Center for the HIV Network for Prevention Trials (HIVNET) since 1994. The transition from HIVNET to HPTN will be described, as will the procedures and organizational structures that will be carried forward into the HPTN and those that will be modified to enhance the objectives of the SDMC.