Menopausal Symptoms Initiative-Finding Lasting Answers for Sweats and Hot Flashes

更年期症状倡议——寻找出汗和潮热的持久答案

• 批准号: 7692434
• 负责人: GARNET L. ANDERSON
• 金额: $ 10万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7692434
• 关键词: Behavioral; Boston; Clinical; Clinical Trials; Collaborations; Data; Data Collection; Data Coordinating Center; Development; Drug Formulations; Hormonal; Hot flushes; Human; Intervention; Leadership; Measurement; Menopausal Symptom; Menopausal hot flushes; Menopause; Methodology; Mission; Phase; Philadelphia; Principal Investigator; Productivity; Publications; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Range; Research Infrastructure; Research Personnel; Resources; Safety; Scientist; Site; Sweat; Sweating; Symptoms; Testing; Vasomotor; Woman; Women' s Health; body-mind; clinical research site; experience; multidisciplinary; protocol development

DESCRIPTION (provided by applicant): The long-term objective of NIA's RFA-AG-08-004 entitled, "New Interventions for Menopausal Symptoms (U01) is to accelerate progress in identifying effective remedies for vasomotor symptoms (VMS) in women going through the menopausal transition. We have created a network of scientists who are highly knowledgeable about the menopausal transition and experienced in the conduct of women's health trials to fulfill this mission. This Data Coordinating Center (DCC) application is being submitted in conjunction with the network entitled, "The Menopausal Symptoms Initiative-Finding Lasting Answers to Sweats and Hot Flashes (MSI-FLASH)". Our DCC will be jointly led by Andrea LaCroix and Garnet Anderson who have served together as Co-Principal Investigators of the Women's Health Initiative Clinical Coordinating Center (Seattle) for more than a decade. The MSI-FLASH network has five clinical sites located in Boston (Lee Cohen and Hadine Joffe, PIs), Indianapolis, IN (Janet Carpenter, PI), Oakland, CA (Barbara Sternfeld and Bette Caan, PIs), Philadelphia (Ellen Freeman, PI) and Seattle (Katherine Newton and Susan Reed, PIs). This multidisciplinary investigator group proposes five randomized controlled trials testing a range of behavioral, mind-body, hormonal and pharmacologic interventions to treat hot flashes. The specific objectives of the DCC are to: 1) Provide and coordinate all necessary leadership activities to facilitate collaboration and productivity among network scientists during all phases in the lifecycle of VMS clinical trials from hypothesis formulation to publication, dissemination, and data sharing; 2) Build upon 15 years of experience and well established human and operational resources to coordinate 5 or more multi- site randomized trials including support of protocol development, recruitment, intervention, data collection and management, and statistical analysis; and 3) Create the infrastructure to involve an expanded network of scientists from the US and worldwide to facilitate the development and use of common methodologies and measurements for VMS trials inside and outside of this trial network so that emerging new treatments for hot flashes can be rapidly identified and rigorously tested for efficacy and safety with comparable results.

描述（由申请人提供）：NIA RFA-AG-08-004的长期目标，标题为“对绝经症状的新干预措施（U01）是在确定有效的血管舒张症状（VMS）（VMS）的有效补救措施方面加速进展妇女的健康试验履行了这一数据协调中心（DCC）的申请。 MSI-Flash网络已有十多年的时间。里德，皮斯）。这个多学科研究者小组提出了五项随机对照试验，测试了一系列行为，思维，荷尔蒙和药理学干预措施，以治疗潮热。 DCC的具体目标是：1）提供并协调所有必要的领导活动，以促进网络科学家之间在VMS临床试验生命周期的所有阶段中的合作和生产力，从假设制定到出版，传播和数据共享； 2）建立在15年的经验和良好的人力和运营资源的基础上，以协调5个或更多场地随机试验，包括支持协议开发，招聘，干预，数据收集和管理以及统计分析； 3）创建基础设施，以涉及从美国和全球的科学家网络扩展的网络，以促进该试验网络内部和外部的常见方法和测量的开发和使用，以便可以快速识别出新的热闪光治疗方法，并严格识别出对可比结果的有效性和安全性的测试。