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.

杀微生物剂试验网络（MTN）正在按计划完成评估 在当前项目中，青少年、孕妇和哺乳期妇女使用达匹韦林阴道环 期不幸的是，由于COVID-19相关的研究中断，这项工作被推迟 活动为了解决这些延迟，MTN统计和数据管理中心（MTN SDMC） 申请延长一年的资金（UM 1AI 068615），以支持这些关键的临床试验，以及 完成对因COVID-19而中断的已完成试验的分析 疫情通过这次延期，MTN SDMC将继续支持开发一个安全和 通过以下方式预防艾滋病毒有效杀微生物剂：1.确保收集完整、高质量的数据， 提供最先进的安全数据管理系统，并根据最佳数据和临床 管理实践。2.在整个方案中提供统计、领导和支持 开发和实施过程，包括研究设计、监测、分析和报告。 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， 包括达匹韦林阴道环的研究。从事MTN的教师的科学领导 SDMC将确保MTN试验的设计旨在为以下最紧迫的问题获得可靠的答案： 杀微生物剂的开发。我们的数据收集、管理、监控和分析系统 经过充分测试，符合ICH指导原则。我们将及时支持领导小组， 在整个随访至研究完成期间准确报告MTN研究。我们将继续支持 MTN LC程序通过协调标本和检测结果，并与统计分析和 方法开发MTN SDMC统计人员将开发和部署统计方法， 提高拟议的杀微生物剂试验计划的效率和严谨性。

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.

在第1阶段试验中，参与者的3个月与1个月的阴道降低了3个月与1个月阴道环的偏好。

• 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

Brief Report: Preventing HIV-1 Infection in Women Using Oral Preexposure Prophylaxis: A Meta-analysis of Current Evidence.

• DOI: 10.1097/qai.0000000000001160
• 发表时间: 2016-12-15
• 期刊: Journal of acquired immune deficiency syndromes (1999)
• 作者: Hanscom B;Janes HE;Guarino PD;Huang Y;Brown ER;Chen YQ;Hammer SM;Gilbert PB;Donnell DJ
• 通讯作者: Donnell DJ