SDMC: HIV Prevention Trials Network

描述（由申请人提供）：本申请继续作为HIV预防试验网络（HPTN）的统计和数据管理中心（SDMC），是组成HPTN领导小组的三个相关申请中的第三个，以响应RFA-AI-12-011：预防HIV感染综合策略临床研究网络（UMI）领导小组。HPTN的科学议程侧重于以下两个调查领域：1）预防艾滋病毒感染的综合战略和2）扩大更有前途的暴露前预防（PrEP）药物和药物方案的视野。本申请描述了SDMC将如何履行RFA中描述的职责，（i）确保研究设计、数据管理、数据分析的完整性并符合监管要求（如适用）;（ii）为网络提供有效的数据通信系统;（iii）为网络附属CTU/CRS研究者和实验室工作人员提供数据管理培训;（iv）在网络内以及与其他NIH支持的网络或其他联邦和私营部门临床试验计划（如需要）的统计和数据管理活动进行标准化和协调;以及 临床数据交换标准联盟（C-DISC）的标准要求。 HPTN SDMC在全球预防研究的设计、实施和分析方面拥有丰富的经验。参与HPTN SDMC的教师的科学领导将确保HPTN试验旨在为预防科学领域最紧迫的问题提供可靠的答案。为了帮助指导制定和测试艾滋病毒预防综合战略的复杂任务，我们将参与一个数学建模的合作计划。新的PrEP药物将通过一系列1期，2期和3期试验开发。我们的数据收集、管理、监控和分析系统均经过严格测试，并符合ICH指南。我们将扩大我们的数据收集工具，包括电子移动的设备，以促进社区和实时行为数据的评估。我们将在整个随访至研究完成期间通过快速、准确的HPTN研究报告支持领导小组。我们将继续通过协调标本和检测结果以及统计分析和方法开发来支持HPTN LC项目。SCHARP统计学家将开发和部署统计方法，以提高拟议的艾滋病毒预防试验计划的效率和严谨性。

DESCRIPTION (provided by applicant): This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Prevention Trials Network (HPTN) is the third of three linked applications comprising the Leadership Group of the HPTN in response to RFA-AI-12-011: Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV infection (UMI). The HPTN scientific agenda focuses on the following two areas of inquiry: 1) integrated strategies to prevent HIV infection and 2) expanding horizons for more promising pre-exposure prophylaxis (PrEP) drugs and drug regimens. This application describes how the SDMC will achieve the responsibilities described in the RFA, (i) ensuring the integrity of study design, data management, data analyses and compliance with regulatory requirements, as appropriate; (ii) providing effective data communication systems for the network; (iii) providing data management training for network-affiliated CTUs/CRSs investigators and laboratory staff; (iv) standardizing and harmonizing statistical and data management activities both within the network and with other NIH-supported networks or other Federal and private sector clinical trial programs when required; and, (vi) collecting and storing data in accordance with standards of the Clinical Data Interchange Standards Consortium (C-DISC) requirements. The HPTN SDMC has extensive experience in the design, conduct and analysis of global prevention studies. The scientific leadership of the faculty engaged in the HPTN SDMC will ensure HPTN trials are designed to obtain reliable answers to the most pressing questions in the prevention science field. To help guide the complex task of developing and testing integrated strategies for HIV prevention, we will engage in a collaborative program of mathematical modeling. New PrEP drugs will be developed through a sequence of Phase 1, 2 and 3 trials. Our systems for data collection, management, monitoring and analysis are all well tested and in accordance with ICH guidelines. We will expand our data collection tools to include electronic mobile devices to facilitate assessment of communities and real-time behavioral data. We will support the leadership group with rapid, accurate reporting of HPTN studies throughout follow-up to study completion. We will continue to support the HPTN LC program through coordination of specimens and assay results, and with statistical analysis and methods development. SCHARP statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of HIV prevention trials.