SDMC: HIV Prevention Trials Network

SDMC：艾滋病毒预防试验网络

• 批准号: 8975587
• 负责人: Deborah J Donnell
• 金额: $ 982.28万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-29 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8975587
• 关键词: AIDS prevention; AIDS/HIV problem; Affect; Area; Behavioral; Biological Assay; Clinical Data; Clinical Research; Clinical Trials; Communication; Communities; Complex; Data; Data Analyses; Data Collection; Electronics; Ensure; Epidemic; Faculty; Goals; Guidelines; HIV; HIV Infections; HIV prevention trial; HIV prevention trials network; Health; Intervention; Laboratories; Leadership; Link; Methodology; Methods; Monitor; Persons; Pharmaceutical Preparations; Phase; Population; Prevention; Private Sector; Prophylactic treatment; Regimen; Reporting; Research Design; Research Personnel; Science; Specimen; Statistical Data Interpretation; Statistical Methods; System; Testing; Time; Training; United States National Institutes of Health; data management; design; experience; follow-up; handheld mobile device; improved; mathematical model; method development; prevent; programs; response; success; support network; tool; transmission process; trial design

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.

描述（由申请人提供）：该申请继续作为艾滋病毒预防试验网络（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：预防艾滋病毒感染综合战略临床研究网络领导小组（UMI）。HPTN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）药物和药物方案的范围。本申请描述了SDMC将如何实现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，并酌情遵守法规要求；（ii）为网络提供有效的数据通讯系统；（iii）为网络附属的中央数据中心/CRSs调查人员和实验室人员提供数据管理培训；（iv）在必要时，规范和协调网络内部以及与其他nih支持的网络或其他联邦和私营部门临床试验项目的统计和数据管理活动；（vi）根据