Statistical and Data Management Center (SDMC): Microbicide Trials Network

统计和数据管理中心 (SDMC)：杀菌剂试验网络

• 批准号: 8552185
• 负责人: Elizabeth Renata Brown
• 金额: $ 338.75万
• 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/8552185
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Affect; Behavioral; Biological; Biological Assay; Clinical Management; Clinical Trials Design; Collection; Complex; Data Collection; Data Quality; Development; Ensure; Epidemic; Epidemiology; Faculty; Goals; Guidelines; HIV; HIV risk; Leadership; Methodology; Methods; Microbicide Trials Network; Monitor; Phase; Process; Reporting; Research Design; Risk Reduction; Secure; Specimen; System; Testing; Training; Vulnerable Populations; cost effective; data management; design; experience; follow-up; improved; innovation; mathematical model; method development; microbicide; programs; protocol development; sound

DESCRIPTION (provided by applicant): This application to continue as the Statistical and Data Management Center (SDMC) for the Microbicide Trials Network (MTN) is one of three applications comprising the Leadership Group of the MTN. To address the overall scientific goal described in RFA-AI-12-008, the development of a safe and effective microbicide for HIV prevention, the MTN SDMC scientific agenda includes the following aims: 1. Ensure the collection of complete, high quality data by providing state-of-the-art secure data management systems and training according to best data and clinical management practices. 2. Provide statistical and epidemiologic leadership and support throughout the protocol development and implementation process, including study design, monitoring and analysis and reporting. 3. Develop and implement innovative statistical and epidemiological approaches to improve the scientific understanding of HIV risk, how microbicides reduce this risk and how this reduction may be modified or influenced by biological and behavioral factors. The MTN SDMC has extensive experience in the design, conduct and analysis of HIV prevention studies. The scientific leadership of the faculty engaged in the MTN SDMC will ensure MTN trials are designed to obtain reliable answers to the most pressing questions in microbicides development. 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 microbicides 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 support the leadership group with timely and accurate reporting of MTN studies throughout follow-up to study completion. We will continue to support the MTN 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 microbicide trials.

描述（由申请人提供）：本申请继续作为杀微生物剂试验网络（MTN）的统计和数据管理中心（SDMC），是构成MTN领导小组的三个申请之一。为了实现RFA-AI-12-008中描述的总体科学目标，即开发一种安全有效的杀微生物剂用于预防艾滋病毒，MTN SDMC科学议程包括以下目标：1.通过提供最先进的安全数据管理系统和根据最佳数据和临床管理实践进行培训，确保收集完整、高质量的数据。2.在整个方案制定和实施过程中提供统计学和流行病学领导和支持，包括研究设计、监测和分析以及报告。3.制定和实施创新的统计和流行病学方法，以提高对艾滋病毒风险、杀微生物剂如何降低这种风险以及生物和行为因素如何改变或影响这种降低的科学认识。MTN SDMC在艾滋病毒预防研究的设计、实施和分析方面拥有丰富的经验。从事MTN SDMC的教师的科学领导将确保MTN试验的设计是为了获得杀微生物剂开发中最紧迫问题的可靠答案。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。新的杀微生物剂将通过一系列的第一、第二和第三阶段试验来开发。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。我们将在整个随访至研究完成期间及时准确报告MTN研究，以支持领导小组。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MTN LC计划。SCHARP统计学家将开发和部署统计方法，以提高拟议的杀微生物剂试验计划的效率和严谨性。