Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

心血管医学心胸外科研究网络

• 批准号: 8488804
• 负责人: Anne Christine Gelijns
• 金额: $ 763.6万
• 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 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8488804
• 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

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）：心脏手术一直是一个非常创新的医学领域。重大创新的引入和持续的渐进式变化延长了许多患有心脏病的患者的生存期并提高了生活质量。快速的创新步伐需要严格的临床评价基础设施，以提供 及时评估新疗法的价值。NHLBI与NINDS和CIHR合作，创建了心胸外科手术试验网络（CTSN），以提供此类基础设施。InCHOIR热情地拥抱与申办者和临床研究者合作的独特机会，作为CTSN DCC。鉴于我们在心脏外科多中心研究的设计和分析方面的长期兴趣和经验，我们提供强大的专业知识，以支持促进这一重要临床研究工作所需的临床和科学协调、沟通、后勤和行政职能。CTSN在设计和实施试验方面面临着重要挑战，包括需要开发科学上严格和可行的试验，以评估心脏病患者的手术治疗，这些试验将作为治疗决策的基础，并将被统一接受。为了迎接这些挑战，我们将在设计创新的探索性临床试验方面发挥领导作用，利用我们在设计新的临床试验方面的经验，解决“现成”设计无法满足的具体需求;建立统一的结果定义;建立一个基于网络的数据库，用于收集和管理试验数据，并在所有研究人员之间共享数据;培训和监测临床研究中心和核心实验室;临床协调、数据管理和质量保证;行政技能和必要的领导能力。我们将通过促进出版过程，在会议上提出，并通过开发一个易于导航的公共和私人研究信息网站，为研究界，执业临床医生和患者提供重要和及时的信息，促进CTSN的研究目标。