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: 10175633
• 负责人: Elizabeth Renata Brown
• 金额: $ 347.1万
• 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 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10175633
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adolescent; Affect; Biological Assay; Breast Feeding; COVID-19; COVID-19 pandemic; Clinical Data; Clinical Management; Clinical Trials; Clinical Trials Design; Code; Collection; Data; Data Collection; Data Management Resources; Databases; Development; Ensure; Epidemic; Faculty; Funding; Good Clinical Practice; Guidelines; HIV; Industry Standard; Information Systems; International; Interruption; Leadership; Methodology; Methods; Microbicide Trials Network; Monitor; Practice Management; Pregnant Women; Procedures; Process; Protocols documentation; Quality Control; Recommendation; Regulation; Reporting; Research Design; Safety; Secure; Specimen; Standardization; Statistical Data Interpretation; Statistical Methods; System; TMC120-R147681; Testing; Time; Training; Vaginal Ring; Vulnerable Populations; Woman; Work; anti-HIV microbicide; clinical trial implementation; cost effective; data management; design; experience; follow-up; implementation process; instrument; method development; microbicide; participant safety; pregnant; programs; protocol development; quality assurance; safety study; sound; statistics; symposium; trial design

The Microbicide Trials Network (MTN) was on track to complete crucial studies assessing the safety of the dapivirine vaginal ring in adolescents, pregnant women and breastfeeding women within the current project period. Unfortunately, this work is being delayed as a result of the COVID-19 associated disruption of study activities. To address these delays, the MTN Statistical and Data Management Center (MTN SDMC) is requesting a one-year extension of funding (UM1AI068615) to support these critical clinical trials as well as for the completion of the analyses of completed trials which have been interrupted due to the COVID-19 epidemic. Through this extension, the MTN SDMC will continue to support the development of a safe and effective microbicide for HIV prevention by: 1. Ensuring 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. Providing statistical and leadership and support throughout the protocol development and implementation process, including study design, monitoring and analysis and reporting. The MTN SDMC has extensive experience in the design, conduct and analysis of HIV prevention studies, including studies of the dapivirine vaginal ring. 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. 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. MTN SDMC statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of microbicide trials.

杀生型试验网络（MTN）正在正常进行完整的关键研究，以评估评估的安全性 当前项目中的青少年，孕妇和母乳喂养的女性的Dapivirine阴道环 时期。不幸的是，由于研究的研究，这项工作被延迟了 活动。为了解决这些延迟，MTN统计和数据管理中心（MTN SDMC）是 要求延长一年的资金（UM1AI068615），以支持这些关键临床试验以及 为了完成由于COVID-19的完整试验的分析 流行性。通过此扩展，MTN SDMC将继续支持安全和 有效预防艾滋病毒的微生物：1。确保收集完整的高质量数据 提供最先进的安全数据管理系统，并根据最佳数据和临床培训 管理实践。 2。在整个协议中提供统计，领导和支持 开发和实施过程，包括研究设计，监视，分析和报告。 MTN SDMC在艾滋病毒预防研究的设计，行为和分析中具有丰富的经验， 包括对Dapivirine阴道环的研究。教师参与MTN的科学领导 SDMC将确保旨在设计MTN试验以获取可靠的答案，以解决最紧迫的问题 微生物的发育。我们用于数据收集，管理，监视和分析的系统都是 经过良好的测试并符合ICH指南。我们将及时支持领导小组 在整个随访过程中，对MTN研究的准确报告。我们将继续支持 MTN LC通过标本和测定结果的协调以及统计分析和 方法开发。 MTN SDMC统计学家将开发并部署统计方法论 提高拟议的杀菌剂试验计划的效率和严格性。

项目成果

Analytic review of modeling studies of ARV Based PrEP interventions reveals strong influence of drug-resistance assumptions on the population-level effectiveness.

• DOI: 10.1371/journal.pone.0080927
• 发表时间: 2013
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Dimitrov D;Boily MC;Brown ER;Hallett TB
• 通讯作者: Hallett TB

Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial.

• DOI: 10.1089/jwh.2021.0121
• 发表时间: 2022-07
• 期刊: JOURNAL OF WOMENS HEALTH
• 影响因子: 3.5
• 作者: Roberts, Sarah T.;Hawley, Imogen;Luecke, Ellen;Mensch, Barbara;Wagner, Theresa;Hoesley, Craig;McClure, Tara;Islas, Clara P. Dominguez;Piper, Jeanna M.;Liu, Albert Y.;van der Straten, Ariane
• 通讯作者: van der Straten, Ariane

High incidence is not high exposure: what proportion of prevention trial participants are exposed to HIV?

• DOI: 10.1371/journal.pone.0115528
• 发表时间: 2015
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Dimitrov D;Donnell D;Brown ER
• 通讯作者: Brown ER

Estimating effectiveness in HIV prevention trials with a Bayesian hierarchical compound Poisson frailty model.

使用贝叶斯分层复合泊松脆弱模型评估艾滋病毒预防试验的有效性。

• DOI: 10.1002/sim.6884
• 发表时间: 2016
• 期刊: Statistics in medicine
• 影响因子: 2
• 作者: Coley,RebeccaYates;Brown,ElizabethR
• 通讯作者: Brown,ElizabethR

Oral antiretroviral pre-exposure prophylaxis reduces the risk of HIV acquisition among men who have sex with men.

口服抗逆转录病毒暴露前预防可降低男男性接触者感染艾滋病毒的风险。

• DOI: 10.1136/ebm1305
• 发表时间: 2011
• 期刊: Evidence-based medicine
• 作者: Boily,Marie-Claude;Mâsse,BenoîtR;Dimitrov,Dobromir
• 通讯作者: Dimitrov,Dobromir