Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

心血管医学心胸外科研究网络

• 批准号: 9753639
• 负责人: Anne Christine Gelijns
• 金额: $ 722.07万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 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 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9753639
• 关键词: Address; Administrative Coordination; Adoption; Agreement; Ancillary Study; Atrial Fibrillation; Canada; Cardiac Surgery procedures; Cardiovascular system; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collaborations; Collection; Communication; Data; Data Analytics; Data Collection; Data Coordinating Center; Data Quality; Data Set; Disease; Effectiveness; Electronic Health Record; Enrollment; Ensure; Event; Fostering; Funding; Goals; Government Agencies; Guidelines; Health; Health Insurance Portability and Accountability Act; Heart Diseases; Heart failure; Industry; Information Technology; Infrastructure; Institutes; Institutional Review Boards; International; Investigation; Journals; Lead; Leadership; Link; Longterm Follow-up; Manuscripts; Mediation; Medicine; Monitor; Multicenter Studies; National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; Natural Language Processing; Neuroprotective Agents; Online Systems; Operative Surgical Procedures; Outcome; Pathway Analysis; Patient Recruitments; Patients; Play; Positioning Attribute; Practice Guidelines; Preparation; Process; Protocols documentation; Publications; Publishing; Quality of life; Regenerative Medicine; Registries; Reporting; Research; Research Personnel; Resources; Review Committee; Role; Safety; Sample Size; Secure; Serious Adverse Event; Site; Source; Statistical Data Interpretation; System; Time; Training; Translating; United States National Institutes of Health; Visit; Work; adjudicate; adjudication; base; biobank; clinical infrastructure; clinical practice; clinical research site; data integrity; data management; data sharing; design; dissemination research; electronic data; electronic data capture system; evidence base; experience; implementation research; implementation science; improved; industry partner; innovation; interest; international center; meetings; mobile application; new technology; novel; novel therapeutics; patient oriented; performance site; prospective; quality assurance; recruit; research clinical testing; research data dissemination; screening; tool; trial design; wearable device

Project Summary Cardiac surgery has been a highly innovative field of medicine. The introduction of major innovations, and ongoing incremental change in existing ones, have extended survival and improved quality of life for many patients suffering from cardiac disease. A rapid pace of innovation requires a rigorous infrastructure for clinical evaluation that provides timely assessments of the value of new and modified treatments. The Cardiothoracic Surgical Trials Network (CTSN) was created to provide a rigorous evidence base tor the surgical treatment of cardiothoracic disease. The International Center for Health Outcomes and Innovation Research (InCHOIR) enthusiastically embraces the opportunity to continue to work in partnership with clinical investigators and the NIH as the CTSN DCC. The Network has developed a rich research agenda for the renewal that includes trials of novel neuroprotective agents, long-term antithrombotic strategies, new regenerative medicine therapies, and surgical approaches to valvular disease, heart failure and atrial fibrillation. Given our long-standing interest and experience in the design and analysis of cardiac surgery multicenter studies, we are in a strong position to serve as the coordinating center for this vital clinical research effort. In particular, we will provide leadership in designing novel trials that optimize sample size, include patient- centered as well as clinical endpoints, and collect data from a variety of sources, including electronic data capture systems, mobile apps and wearable sensors, registries and electronic health records. We have a strong track record of obtaining efficient regulatory approval for our trials from the FDA and Health Canada, training and monitoring sites nationally and internationally, ensuring robust enrollment and retention, data management and quality assurance, data sharing, and overall administrative coordination. We have the infrastructure to expand our trials to include mechanistic studies that use biospecimens collected and managed through the CTSN biorepository. Finally, the DCC plays an important role in the analysis, interpretation and dissemination of research findings. We will continue to support the process of publishing in high-impact journals that should lead to revision of practice guidelines and to surgical practice itself. This goal should be further optimized by incorporating Implementation Science approaches into Network trials, which should decrease the well-recognized gap between publication of trial results and adoption of findings into widespread practice.

项目摘要 心脏外科一直是一个高度创新的医学领域。重大创新的推出，以及 持续不断的现有变化，延长了许多人的生存时间，提高了他们的生活质量 患有心脏病的患者。快速的创新步伐需要严格的临床基础设施 对新疗法和改良疗法的价值进行及时评估的评估。心胸外科 外科试验网络(CTSN)的建立是为了为外科治疗提供严格的证据基础 心胸疾病。 国际健康成果和创新研究中心(INCHOIR)热情地接受 作为CTSN DCC，有机会继续与临床研究人员和美国国立卫生研究院合作。 该网络为更新制定了丰富的研究议程，其中包括新的神经保护试验 药物、长期抗血栓策略、新的再生医学疗法和外科手术方法 心脏瓣膜病、心力衰竭和心房颤动。鉴于我们长期以来对 设计和分析心脏外科多中心研究，我们处于有利地位，可以作为 这项重要的临床研究工作的协调中心。 特别是，我们将在设计优化样本量的新型试验方面发挥领导作用，包括患者- 以临床终点为中心，并从各种来源收集数据，包括电子数据 捕获系统、移动应用程序和可穿戴传感器、登记簿和电子健康记录。我们有一个 我们的试验获得FDA和加拿大卫生部有效监管批准的良好记录， 国内和国际培训和监测站点，确保强劲的招生和保留，数据 管理和质量保证、数据共享和整体行政协调。我们有 基础设施，以扩大我们的试验，包括使用收集和管理的生物杀虫剂的机械性研究 通过CTSN生物储存库。最后，DCC在分析、解释和分析中发挥了重要作用 研究成果的传播。我们将继续支持高影响力的出版进程 应导致修订实践指南和外科实践本身的期刊。这个目标应该是 通过将实施科学方法纳入网络试验进一步优化，网络试验应 缩小试验结果公布和结果被广泛采用之间公认的差距 练习一下。