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“更年期症状的新干预措施（U01）”的长期目标是加速确定更年期过渡妇女血管舒缩症状（VMS）的有效补救措施的进展。我们已经建立了一个科学家网络，他们对更年期过渡非常了解，并且在妇女健康试验方面经验丰富，以完成这一使命。该数据协调中心（DCC）申请正在与题为“更年期症状倡议-寻找出汗和潮热的持久答案（MSI-FLASH）”的网络一起提交。我们的DCC将由安德里亚·拉克鲁瓦和加内特·安德森共同领导，他们在妇女健康倡议临床协调中心（西雅图）共同担任了十多年的首席研究员。MSI-FLASH网络有五个临床站点，分别位于波士顿（Lee Cohen和Hadine Joffe，私家侦探）、印第安纳州印第安纳波利斯（Janet Carpenter，私家侦探）、加州奥克兰（Barbara Sternfeld和Bette Caan，私家侦探）、费城（Ellen Freeman，私家侦探）和西雅图（Katherine Newton和Susan Reed，私家侦探）。这个多学科研究小组提出了五个随机对照试验，测试一系列行为、身心、激素和药物干预来治疗潮热。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VMS临床试验生命周期中从假设制定到发表、传播和数据共享的各个阶段网络科学家之间的协作和生产力；2)基于15年的经验和完善的人力和业务资源，协调5个或更多的多地点随机试验，包括方案制定、招募、干预、数据收集和管理以及统计分析的支持；3)建立基础设施，包括来自美国和世界各地的科学家网络，以促进VMS试验的共同方法和测量方法的开发和使用，以便新兴的潮热治疗方法可以迅速确定，并严格测试其有效性和安全性，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.