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) 有望完成评估杀微生物剂安全性的重要研究 当前项目中针对青少年、孕妇和哺乳期妇女的达匹韦林阴道环 时期。不幸的是，由于与 COVID-19 相关的研究中断，这项工作被推迟 活动。为了解决这些延迟问题，MTN 统计和数据管理中心 (MTN SDMC) 请求将资金延长一年（UM1AI068615）以支持这些关键的临床试验以及 用于完成因 COVID-19 中断的已完成试验的分析 流行性。通过此次延期，MTN SDMC 将继续支持安全、可靠的发展 通过以下方式有效预防艾滋病毒的杀菌剂： 1. 确保收集完整、高质量的数据 根据最佳数据和临床提供最先进的安全数据管理系统和培训 管理实践。 2. 在整个协议过程中提供统计、领导和支持 制定和实施过程，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 的教师的科学领导力 SDMC 将确保 MTN 试验的设计能够为最紧迫的问题获得可靠的答案 杀菌剂的开发。我们的数据收集、管理、监控和分析系统都是 经过充分测试并符合 ICH 指南。我们将及时、有力地支持领导班子 在研究完成的整个后续过程中准确报告 MTN 研究。我们将继续支持 MTN LC 程序通过协调样本和检测结果以及统计分析和 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.

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