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，特别是在心胸（CT）外科领域，正在蓬勃发展。正如NHLBI所认识到的那样，CT手术领域缺乏多中心的学术基础设施，用于新手术和微创手术的概念验证试验，而拟议的心胸外科手术研究网络打算解决这一问题。鉴于我们在心脏手术试验的设计和实施方面的长期兴趣和经验，国际健康结局和创新研究中心热烈欢迎有机会与NIH和网络研究者合作，作为网络的数据协调中心（DCC）。特别是，我们将为网络提供以下服务：试验设计和方案开发-DCC将在创新II期临床试验的设计中提供支持和领导，采用最佳多阶段设计，多组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贝叶斯方法的实施。它将制定方案、病例报告表和操作手册。临床协调-DCC将定期与网络研究者联系，以帮助审查患者入组、讨论招募策略、协助研究者起草管理指南，并帮助审查网络患者的管理。数据管理-DCC将提供一个安全、有效、集中的电子数据管理设施，符合HIPAA和FDA标准。DCC将开发和维护系统，以便能够通过网络直接输入数据，并将提供自动化的患者随机化、时间戳、文件存档、数据验证和报告服务，以及技术支持服务台。研究中心管理、质量保证和监测-DCC将对临床研究者进行方案细节方面的培训，审查数据质量，发出质询，定期监测研究中心以确保数据完整性，并协助死亡率和死亡率（M&M）委员会裁定数据。统计和分析支持-DCC将生成随机化治疗分配，为数据安全和监查委员会（DSMB）进行中期分析，为所有网络试验进行最终分析，并参与研究报告和手稿的准备。网络的行政支持-DCC将支持网络的所有组件、方案审查委员会、指导委员会、核心实验室和DSMB。DCC将负责报销患者累积费用，并组织所有网络会议。 (End摘要）

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)