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.
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