Leadership for HIV/AIDS Clinical Trials Networks; Microbicide Trials Network

艾滋病毒/艾滋病临床试验网络的领导；

• 批准号: 8289674
• 负责人: Elizabeth Renata Brown
• 金额: $ 363.74万
• 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 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8289674
• 关键词: AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Animal Model; Biological Assay; Case Report Form; Clinical Trials; Clinical Trials Network; Common Data Element; Data; Data Collection; Data Set; Disease Progression; Epidemic; Goals; Guidelines; HIV vaccine; Infection; Leadership; Methodology; Microbicide Trials Network; Monitor; Prevention Research; Process; Prophylactic treatment; Protocols documentation; Publications; Randomized; Reporting; Retrieval; Security; System; Testing; Training; Vaccines; data management; design; experience; microbicide; novel; operation; programs; public health priorities; statistical center; vaginal microbicide

DESCRIPTION (Provided by applicant): This application to be 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. The MTN scientific agenda focuses exclusively on RFA priority number 4: "Microbicides." This application describes how the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) will achieve the aims of the RFA to (1) provide statistical leadership for the design, conduct, analysis and publication of Network clinical trials/studies; (2) provide central data management capability that includes randomization, data set and case report form design, central storage, security, processing and retrieval of study results; (3) provide data management and protocol training throughout the Network; (4) provide data-focused clinical trials implementation, and operation; and (5) contribute to cross-Network efforts in developing common data elements and data interfaces. SCHARP has extensive experience in the design, conduct and analysis of global HIV vaccine and prevention studies. Thus, the systems we propose to use for data collection, management, monitoring, and analysis are all well tested and in accordance with ICH guidelines. SCHARP statisticians will also develop and deploy novel statistical methodologies to increase the efficiency and rigor of the proposed program of microbicide trials. The HIV/AIDS epidemic continues to expand in almost all regions of the world, with approximately 4.8 million new infections in 2003 (UNAIDS 2004 Report on the Global AIDS Epidemic). Although finding a vaccine to protect against infection and/or disease progression is a public-health priority, it is recognized that this goal may be years away. Therefore, the need for finding other types of effective prevention measures is critical. Only through clinical trials held to the highest scientific and regulatory standards will this goal be achieved.

描述（由申请人提供）： 该应用程序将成为杀菌剂试验网络 (MTN) 的统计和数据管理中心 (SDMC)，是组成 MTN 领导小组的三个应用程序之一。 MTN 科学议程专门关注 RFA 优先事项 4：“杀微生物剂”。该应用程序描述了艾滋病毒/艾滋病研究与预防统计中心 (SCHARP) 将如何实现 RFA 的目标：(1) 为网络临床试验/研究的设计、实施、分析和发布提供统计领导； (2) 提供中央数据管理能力，包括随机化、数据集和病例报告表设计、研究结果的中央存储、安全、处理和检索； (3) 提供全网数据管理和协议培训； （4）提供以数据为中心的临床试验实施、运营； (5) 为开发通用数据元素和数据接口方面的跨网络工作做出贡献。 SCHARP 在全球艾滋病疫苗和预防研究的设计、实施和分析方面拥有丰富的经验。因此，我们建议用于数据收集、管理、监测和分析的系统都经过充分测试并符合 ICH 指南。 SCHARP 统计学家还将开发和部署新的统计方法，以提高拟议的杀菌剂试验计划的效率和严谨性。 艾滋病毒/艾滋病的流行在世界几乎所有地区继续扩大，2003 年新增感染者约 480 万（联合国艾滋病规划署 2004 年全球艾滋病流行报告）。尽管寻找一种疫苗来预防感染和/或疾病进展是公共卫生的首要任务，但人们认识到这一目标可能还需要数年时间。因此，寻找其他类型的有效预防措施至关重要。只有通过遵守最高科学和监管标准的临床试验才能实现这一目标。

项目成果

The future role of rectal and vaginal microbicides to prevent HIV infection in heterosexual populations: implications for product development and prevention.

• DOI: 10.1136/sextrans-2011-050184
• 发表时间: 2011-12
• 期刊: Sexually transmitted infections
• 影响因子: 3.6
• 作者: Boily MC;Dimitrov D;Abdool Karim SS;Mâsse B
• 通讯作者: Mâsse B

Efficacy dilution in randomized placebo-controlled vaginal microbicide trials.

• DOI: 10.1186/1742-7622-6-5
• 发表时间: 2009-10-09
• 期刊: Emerging themes in epidemiology
• 影响因子: 2.3
• 作者: Mâsse BR;Boily MC;Dimitrov D;Desai K
• 通讯作者: Desai K

Incremental role of male circumcision on a generalised HIV epidemic through its protective effect against other sexually transmitted infections: from efficacy to effectiveness to population-level impact.

• DOI: 10.1136/sti.2008.030346
• 发表时间: 2008-10
• 期刊: Sexually transmitted infections
• 影响因子: 3.6
• 作者: Boily MC;Desai K;Masse B;Gumel A
• 通讯作者: Gumel A

Heterosexual risk of HIV-1 infection per sexual act: systematic review and meta-analysis of observational studies.

• DOI: 10.1016/s1473-3099(09)70021-0
• 发表时间: 2009-02
• 期刊: LANCET INFECTIOUS DISEASES
• 影响因子: 56.3
• 作者: Boily, Marie-Claude;Baggaley, Rebecca F.;Wang, Lei;Masse, Benoit;White, Richard G.;Hayes, Richard J.;Alary, Michel
• 通讯作者: Alary, Michel

Who will Benefit from a Wide-Scale Introduction of Vaginal Microbicides in Developing Countries?

• DOI: 10.2202/1948-4690.1012
• 发表时间: 2010-01
• 期刊: Statistical communications in infectious diseases
• 作者: Dimitrov DT;Masse B;Boily MC
• 通讯作者: Boily MC