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Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

心血管医学心胸外科研究网络

基本信息

批准号：
8703161
负责人：
Anne Christine Gelijns
金额：
$ 939.4万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-07-01 至 2016-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8703161
关键词：
Address Agreement Archives Area Cardiac Surgery procedures Cardiovascular system Case Report Form Clinical Clinical Data Clinical Investigator Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials Design Collaborations Collection Communication Community Practice Coronary Data Data Quality Databases Effectiveness Enrollment Ensure Event Face Funding Government Agencies Guidelines Health Health Insurance Portability and Accountability Act Heart Diseases Institutes Institutional Review Boards Internet Investigation Laboratories Leadership Manuals Manuscripts Mechanics Mediation Medical Medicine Methodology Methods Monitor Multicenter Studies Myocardial Revascularization National Heart, Lung, and Blood Institute National Institute of Neurological Disorders and Stroke Observational Study Online Systems Operative Surgical Procedures Outcome Patient Recruitments Patients Preparation Private Sector Process Protocols documentation Publications Quality of life Randomized Reporting Research Research Infrastructure Research Personnel Resources Review Committee Role Safety Secure Serious Adverse Event Services Site Staging Surrogate Endpoint System Teleconferences Telephone Time Training Translating United States National Institutes of Health Validation Work abstracting adjudicate adjudication base clinical research site data integrity data management data sharing design dissemination research electronic data experience improved industry partner innovation interest international center meeting abstracts meetings network models novel operation public health relevance quality assurance research clinical testing screening skills web site

项目摘要

DESCRIPTION (provided by applicant): Cardiac surgery has been a spectacularly innovative field of medicine. The introduction of major innovations and ongoing incremental change 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 treatments. The NHLBI, in collaboration with NINDS and CIHR, created the Cardiothoracic Surgical Trials Network (CTSN) to provide such an infrastructure. InCHOIR enthusiastically embraces the unique opportunity to work in partnership with the sponsors and clinical investigators as the CTSN DCC. Given our long-standing interest and experience in the design and analysis of cardiac surgery multicenter studies, we offer strong expertise to support clinical and scientific coordination, communication, logistical, and administrative functions necessary to promote this vital clinical research effort. The CTSN faces important challenges in designing and implementing trials, including the need to develop scientifically rigorous and feasible trials for evaluating surgical treatments for patients with cardiac disease that will serve as, and will be uniformly accepted as, the basis for treatment decisions. To meet these challenges we will provide leadership in the design of innovative exploratory clinical trials, exploiting our experience in designing novel clinical trials addressin specific needs not met by "off the shelf" designs; establish uniform outcome definitions; a web-based database for the collection and management of trial data and sharing of data among all investigators; training and monitoring of the clinical sites and core laboratories; clinical coordination, data management and quality assurance; administrative skills and the necessary leadership. We will promote the CTSN research objectives by facilitating the publication process, presenting at meetings and by developing an easily navigable public and private study informational website that provides important and timely information to the research community, practicing clinicians, and patients.

描述（由申请人提供）：心脏外科一直是一个引人注目的创新医学领域。重大创新的引入和持续的渐进式变化延长了许多心脏病患者的生存期，改善了他们的生活质量。快速的创新步伐需要严格的临床评估基础设施