HIV PREVENTION TRIALS NETWORK LEADERSHIP GROUP

本申请是由Fred哈钦森癌症研究中心（FHCRC）为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，旨在成为拟议的HIV预防试验网络（HPTN）的统计和数据管理中心（SDMC）。华盛顿大学公共卫生和社区医学学院生物统计系将成为FHCRC的共同申请人和分包商。此SDMC应用程序是由HIV预防试验网络（HPTN）领导小组组成的三个组件应用程序中的一个组件。单独的申请描述了核心申请人，家庭健康国际公司，小威拉德·凯茨医生PI和中心实验室申请人约翰霍普金斯大学，布鲁克斯博士，PI。这一新网络的主要科学领导组成部分的组织情况见第1节，其中包括执行委员会、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。核心申请包含HPTN如何建议执行其科学议程的详细描述。该应用程序利用了FHCRC和UW提供的特殊优势。FHCRC有几个大型的统计和数据管理协调中心，用于多中心和多方案试验组。华盛顿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广泛的生物统计学，流行病学和临床经验，以及在进行临床试验方面的丰富经验。Self博士和Fleming博士在这两个机构都有教职人员（Self博士是FHCRC生物统计学项目的负责人，Fleming博士是UW生物统计学系的主席），AS博士黄和理查森。由于自1972年FHCRC成立以来，两个机构之间存在着紧密的联系，几乎所有FHCRC教师和许多UW教师都持有联合任命，因此，从学术角度来看，他们可以被视为同一机构。本申请首先介绍了有关艾滋病毒流行和预防工作的一般背景说明，包括正在进行的和拟议的预防工作，以减少各种病毒传播方式。申请的其余部分是SDMC特有的，SDMC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（HIVNET）统计中心的经验。将介绍从艾滋病毒信息网向高分组网络的过渡，以及将转入高分组网络的程序和组织结构，以及将为加强SDMC的目标而修改的程序和组织结构。

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.