Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine(U01

心血管医学心胸外科研究网络(U01

• 批准号: 7471502
• 负责人: MICHAEL K PARIDES
• 金额: $ 29.06万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-10-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7471502
• 关键词: Address; Archives; Area; Arrhythmia; Cardiac Surgery procedures; Cardiomyopathies; Cardiovascular system; Case Report Form; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Data Monitoring Committees; Coronary Artery Bypass; Data; Data Coordinating Center; Data Quality; Electronics; End Point; Enrollment; Ensure; Facility Construction Funding Category; Foundations; Guidelines; Health; Health Insurance Portability and Accountability Act; Heart Diseases; Heart Valves; Internet; Investigation; Leadership; Left; Manuals; Manuscripts; Medicine; Minimally Invasive Surgical Procedures; Monitor; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Patients; Phase; Preparation; Procedures; Protocols documentation; Quality of life; Randomized; Randomized Controlled Clinical Trials; Reporting; Research; Research Infrastructure; Research Personnel; Review Committee; Secure; Selection for Treatments; Services; Site; Staging; Standards of Weights and Measures; Surrogate Endpoint; System; Telephone; Therapeutic Intervention; Time; Training; United States National Institutes of Health; Upper arm; Validation; abstracting; adjudicate; base; concept; data integrity; data management; design; experience; improved; innovation; interest; international center; mortality; novel; protocol development; quality assurance; repaired; research clinical testing; ventricular assist device

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)

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展，治疗干预措施，特别是心胸 (CT) 手术领域，正在蓬勃发展。 NHLBI 认识到，CT 手术领域缺乏用于新型手术和微创手术概念验证试验的多中心学术基础设施，而拟议的心胸外科研究网络旨在解决这一问题。鉴于我们对心脏手术试验的设计和进行的长期兴趣和经验，国际健康结果和创新研究中心热忱欢迎有机会与 NIH 和网络研究者合作，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 将在创新型 II 期临床试验的设计、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型贝叶斯方法的实施方面提供支持和领导。它将制定方案、病例报告表（CRF）和操作手册。临床协调 - DCC 将与网络调查人员定期联系，以帮助审查患者入组情况、讨论招募策略、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、经过验证的集中式电子数据管理设施，且符合 HIPAA 和 FDA 标准。 DCC 将开发和维护系统，以便通过网络直接输入数据，并将提供自动患者随机化、时间戳、文件归档、数据验证和报告服务以及技术支持服务台。站点管理、质量保证和监测 - DCC 将培训临床研究人员了解方案的具体细节、审查数据质量、发出查询、定期监控站点以确保数据完整性，并协助发病率和死亡率 (M&M) 委员会裁定数据。统计和分析支持 - DCC 将生成随机治疗分配，为数据安全和监测委员会 (DSMB) 进行中期分析，对所有网络试验进行最终分析，并参与研究演示文稿和手稿的准备。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 DSMB。 DCC 将负责报销患者应计费用，并组织所有网络会议。 （摘要完）