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

描述(由申请人提供)：NIA的RFA-AG-08-004题为“针对更年期症状的新干预措施(U01)”的长期目标是加快在寻找针对处于更年期过渡的妇女的血管舒缩症状(VMS)的有效疗法方面的进展。我们已经建立了一个科学家网络，他们对更年期过渡有高度的了解，并在妇女健康试验的进行方面有经验，以完成这一使命。这一数据协调中心(DCC)的申请是与名为“更年期症状倡议-寻找汗水和潮热的持久答案(MSI-FLASH)”的网络一起提交的。我们的DCC将由Andrea LaCroix和Garnet Anderson共同领导，他们一起担任妇女健康倡议临床协调中心(西雅图)的联合首席研究员已有十多年。MSI-Flash网络有5个临床站点，分别位于波士顿(Lee Cohen和Hadine Joffe，PI)、印第安纳波利斯、IN(Janet Carpenter，PI)、加利福尼亚州奥克兰(Barbara Sternfeld和Bette Caan，PI)、费城(Ellen Freeman，PI)和西雅图(凯瑟琳·牛顿和苏珊·里德，PI)。这个多学科的研究小组提出了五个随机对照试验，测试一系列行为、精神-身体、激素和药物干预措施来治疗潮热。DCC的具体目标是：1)提供和协调所有必要的领导活动，以促进网络科学家在VMS临床试验生命周期的所有阶段(从假设制定到发表、传播和数据共享)之间的协作和生产力；2)以15年的经验和成熟的人力和运营资源为基础，协调5项或更多多地点随机试验，包括支持方案制定、招募、干预、数据收集和管理以及统计分析；以及3)建立基础设施，让来自美国和世界各地的科学家组成一个扩大的网络，以促进在该试验网络内外开发和使用VMS试验的通用方法和测量方法，以便能够快速识别正在出现的潮热新疗法，并对其有效性和安全性进行严格测试，并获得可比较的结果。

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.