Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine(U01

描述(由申请人提供)： 医学的科学基础正在以前所未有的速度扩大，治疗干预措施，特别是在心胸(CT)外科领域，正在蓬勃发展。正如NHLBI承认的那样，CT外科领域缺乏多中心的学术基础设施，用于新型外科和微创手术的概念验证试验，而拟议的心胸外科调查网络打算解决这一问题。鉴于我们在设计和实施心脏手术试验方面的长期兴趣和经验，国际健康结果和创新研究中心热烈欢迎有机会与NIH和网络调查人员合作，担任网络的数据协调中心(DCC)。特别是，我们将为该网络提供以下服务：试验设计和方案开发-DCC将在创新的II1型临床试验的设计方面提供支持和领导，采用最佳的多阶段设计，多臂研究中的治疗选择程序，替代终点的选择，复合终点的构建，以及新型贝叶斯方法的实施。它将制定方案、案例报告表(CRF)和操作手册。临床协调-DCC将与网络调查人员保持定期联系，以帮助审查患者登记、讨论招募战略、协助调查人员起草管理指南，并帮助审查网络患者的管理。数据管理-DCC将提供安全的、经过验证的、符合HIPAA和FDA标准的集中式电子数据管理设施。DCC将开发和维护能够通过网络直接输入数据的系统，并将提供自动患者随机化、时间戳、文件存档、数据验证和报告服务，以及一个技术支持服务台。现场管理、质量保证和监测-DCC将对临床调查人员进行方案细节方面的培训，审查数据的质量，发出查询，定期监测现场以确保数据的完整性，并协助发病率和死亡率(M&M)委员会对数据进行裁决。统计和分析支持-DCC将生成随机处理任务，为数据安全和监测委员会(DSMB)执行中期分析，为所有网络试验执行最终分析，并参与研究报告和手稿的准备。对网络的行政支持--DCC将支持网络的所有组成部分、协议审查委员会、指导委员会、核心实验室和数字业务监测系统。DCC将负责患者应计费用的报销，并组织所有网络会议。 (摘要结束)

DESCRIPTION (provided by applicant): The scientific foundations of medicine are broadening at an unprecedented pace and therapeutic interventions, particularly in the area of cardiothoracic (CT) surgery, are burgeoning. As recognized by the NHLBI, the CT surgery field lacks a multi-center, academic infrastructure for proof-of-concept trials of novel surgical and minimally invasive procedures, which the proposed Cardiothoracic Surgery Investigations Network intends to address. Given our long-standing interest and experience in the design and conduct of cardiac surgery trials, the International Center for Health Outcomes and Innovation Research enthusiastically welcomes the opportunity to collaborate with NIH, and the Network Investigators to serve as the Data Coordinating Center (DCC) for the Network. In particular, we will offer the following services to the Network: Trial Design and Protocol Development - The DCC will offer support and leadership in the design of innovative Phase ll-type clinical trials, employing optimal multi-stage designs, procedures for treatment selection in multi-arm studies, selection of surrogate endpoints, construction of composite endpoints, and implementation of novel Bayesian approaches. It will develop protocols, case report forms (CRFs) and operations manuals. Clinical Coordination - The DCC will be in regular contact with Network investigators to help review patient enrollment, discuss recruitment strategies, assist the investigators in drafting management guidelines, and help review the management of Network patients. Data Management - The DCC will provide a secure, validated, centralized electronic data management facility that is HIPAA and FDA-compliant. The DCC will develop and maintain systems to enable direct data entry via the Web, and it will provide automated patient randomization, time stamping, file archiving, data validation and reporting services, and a help desk for technical support. Site Management, Quality Assurance, and Monitoring - The DCC will train clinical investigators in the specifics of the protocol, review the quality of the data, issue queries, monitor the sites on a regular basis to ensure data integrity, and assist the Morbidity and Mortality (M&M) Committee in adjudicating the data. Statistical and Analytical Support - The DCC will generate randomized treatment assignments, perform interim analyses for the Data Safety and Monitoring Board (DSMB), perform final analyses for all Network trials, and participate in the preparation of study presentations and manuscripts. Administrative Support for the Network - The DCC will support all components of the Network, the Protocol Review Committee, the Steering Committee, the Core labs, and the DSMB. The DCC will be responsible for reimbursement for patient accrual, and organize all Network meetings. (End of Abstract)