2/2 PROmote weight loss in obese PAD patients to preVEnt mobility loss: The PROVE Trial--DCC

验证试验DCC项目总结 这份来自维克森林医学院(WFSM)的U24申请描述了经验丰富的投资机构的计划- 老虎和工作人员将作为促进肥胖垫减肥的数据协调中心(DCC) 防止活动能力丧失的患者：Proven试验(Proven)，N=212。我们将在成功的基础上再接再厉 在数十项大型、长期试验和流行病学研究中。我们的DCC经验将有助于确保成功 通过监督试验的所有与数据相关的方面来实施证明试验。我们有一间单人房 SPECIfic目标：提供项目协调、管理、数据管理和生物统计支持 证明会审判。我们将通过以下方式实现这一目标：促进和指导议定书制定进程 提供科学的fi合理的研究设计，卓越的操作和分析方法，专注于 关于招聘，高质量的跟踪和fi对干预的承诺，监测安全和与 Dsmb确保参与者的安全和仔细的研究管理，与ccc合作监控field cen- TERS(即，西北、明尼苏达和杜兰)，并通过领导协议的开发和维护， 程序手册(MOP)、表格和其他研究文件。我们相信，Proven审判将有近 大型多中心研究的所有复杂性，特别是对DCC来说，在跨站点标准化方面。 我们有几个优势：(1)团队成员是多中心试验协调方面的专家， 包括正在进行的几项，(2)心血管疾病(CVD)试验经验，包括当前 Sprint试验，(3)锻炼和减肥试验中建议的干预经验 证明试验，(4)特殊的fic项目管理专业知识，(5)有效和有效的沟通的历史 与fi老年中心、执行委员会和fice项目合作，以及(6)与麦克德莫特博士成功合作 (CCC)之前的两项研究(LIFE和ENRGISE)。 WFSM将临床试验的进行和协调视为一项科学的fic事业，它通过 持之以恒的评价创新。虽然已经进行了基于网络的随机对照试验(RCT) 在近二十年的时间里，我们将继续开发新的和创新的战略，以整合基于Web的 将技术纳入日常审判活动，并将其他电子数据捕获方法纳入审判人-- 管理人员。我们协调了ACCORD，这是fi第一次主要通过网络协调的大规模随机对照试验。 ACCORD系统已演变为EFfi有效管理临床试验操作的数据库 (执事)基于网络的审判管理系统，我们在所有研究中都使用该系统。我们一直在- 发布和评估要添加到Deacon框架中的新功能。 WFSM经验丰富且才华横溢的团队将为Proven试验创建最先进的DCC 使用经过验证的(双关语)协调中心模型。人员将从第一天开始可用，并已有很长时间- 美国国立卫生研究院资助的多项研究中的长期工作关系。

The PROVE Trial DCC Project Summary This U24 application from the Wake Forest School of Medicine (WFSM) describes plans by experienced inves- tigators and staff to serve as the Data Coordinating Center (DCC) for the PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial (PROVE), a N=212 trial. We will build on our successes in dozens of large, long-term trials and epidemiologic studies. Our DCC experience will help ensure success in the implementation of the PROVE Trial by overseeing all data related aspects of the trial. We have a single specific aim: to provide project coordination, administration, data management, and biostatistical support for the PROVE Trial. We will accomplish this aim by facilitating and guiding the protocol development process, by providing scientifically sound study design, excellent operational and analytical methodology, a dedicated focus on recruitment, high quality follow-up and fidelity to the intervention, monitoring safety and working with the DSMB to ensure participant safety and careful study management, working with the CCC to monitor field cen- ters (i.e., Northwestern, Minnesota, and Tulane), and by leading development and maintenance of the protocols, manual of procedures (MOP), forms and other study documents. We believe that PROVE Trial will have nearly all the complexities of large multi-center studies, particularly for the DCC in standardization across sites. We have several strengths: (1) a team whose members are experts in the coordination of multi-center trials, including several that are ongoing, (2) experience with cardiovascular disease (CVD) trials including the current SPRINT trial, (3) experience with exercise and weight loss trials working with the intervention proposed in the PROVE trial, (4) specific project management expertise, (5) a history of efficient and effective communication with field centers, the executive committee, and the project office, and (6) success working with Dr. McDermott (of the CCC) on two prior studies (LIFE and ENRGISE). WFSM views clinical trial conduct and coordination as a scientific undertaking, which advances through con- tinuous evaluation and innovation. While web-based randomized controlled trials (RCTs) have been conducted for almost two decades, we will continue to develop new and innovative strategies for integrating web-based technology into daily trial activities and incorporating other methods of electronic data capture into trial man- agement. We coordinated ACCORD, which was the first large-scale RCT coordinated primarily over the web. The ACCORD system has evolved into the Database for Efficient Administration of Clinical trial OperatioNs (DEACON) system for web-based trial management which we use for all of our studies. We are constantly in- venting and evaluating new features to add to the DEACON framework. The highly experienced and talented team at WFSM will create a state-of-the-art DCC for the PROVE trial using proven (pun intended) coordinating center models. Personnel will be available from day 1 and have long- standing working relationships across multiple NIH-funded studies.