Heart Failure Clinical Research Network Regional Clinical Center (U10)

心力衰竭临床研究网络区域临床中心 (U10)

• 批准号: 8791701
• 负责人: GARY M FELKER
• 金额: $ 50.81万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-01-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8791701
• 关键词: Academic Medical Centers; Achievement; Acute; Address; Ancillary Study; Basic Science; Biometry; Clinical; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collaborations; Communities; Cost effectiveness research; Data; Data Collection; Data Coordinating Center; Data Quality; Development; Diagnosis; Environment; Epidemiology; Ethnic Origin; Future Generations; Gender; Goals; Health; Heart failure; International; Intervention; Master' s Degree; Measures; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Outcome; Participant; Patient Care; Patient Recruitments; Patients; Performance; Persons; Policies; Population Heterogeneity; Prevention; Principal Investigator; Procedures; Protocols documentation; Race; Randomized Clinical Trials; Recruitment Activity; Research; Research Design; Research Infrastructure; Research Personnel; Research Training; Resolution; Review Committee; Science; Site Visit; Statistical Methods; Syndrome; Therapy Evaluation; TimeLine; Training; Training Programs; Underrepresented Minority; Writing; base; clinical investigation; design; experience; follow-up; human subject protection; improved; innovation; meetings; next generation; novel; patient oriented; protocol development; quality assurance; research and development; skills; success; symposium; tocol

Composite PROJECT SUMMARY The overriding objective of this proposal for the Duke University Medical Center Regional Clinical Center (Duke RCC) for the Heart Failure Clinical Research Network (HF Network) is to improve the care of patients with heart failure through high-impact patient-oriented clinical research. This objective will be achieved through active collaboration with all components of the HF Network, including other RCCs, the Data Coordinating Center (DCC), associated core labs, and the NHLBI. The overall goal of the HF network is to improve outcomes through optimal application of existing therapies, evaluation of novel therapies, and to facilitate application of emerging basic science discoveries into clinical investigations. We believe the Duke RCC is highly capable of contributing to the successful achievement of these objectives based on a demonstrated record of developing original, innovative, high impact clinical research protocols addressing clinically important research questions in heart failure, and propose a novel protocol targeting acute heart failure patients, the CAPTAIN study, in this application. The Duke RCC has proven ability to recruit scientifically appropriate and ethnically and racially diverse populations of patients into HF Network clinical protocols and provide data that is accurate, complete, timely, and regulatory compliant. As detailed in this proposal, the Duke RCC has a dedicated and experienced team of investigators, combining a broad array of clinical, research, and operational skills that collectively will make a major contribution to the overall success of the HF Network. The Duke RCC we will participate in the development of research protocols, statistical methods, and plans for data collection and protocol implementation. We will provide input where appropriate into study design from both a scientific and a feasibility standpoint. We will implement each network-wide protocol approved by the protocol review committee (PRC) and the NHLBI; comply with study policies and quality assurance measures approved by the Steering Committee, and agree to oversight of the study by a Data and Safety Monitoring Board (DSMB). Finally, the Duke RCC will develop a Clinical Research Skills Development Core to train future generations of heart failure researchers. RELEVANCE (See instnjctions): This proposal for the Duke Regional Clinical Center of the NHLBI Heart Failure Clinical Research Network will develop and implement high impact, scientifically rigorous randomized clinical trials designed to improve the health of persons with heart failure. The results of the proposed research will have immediate clinical implications for millions of patients with heart failure.

复合 项目摘要 杜克大学医学中心区域临床研究的主要目标是 中心（杜克RCC）的心力衰竭临床研究网络（HF网络）是为了改善 通过高影响力的以患者为导向的临床研究来护理心力衰竭患者。这一目标 将通过与高频网络的所有组成部分，包括其他 RCC、数据协调中心（DCC）、相关核心实验室和NHLBI。的总目标 HF网络的目标是通过最佳应用现有疗法、评估 新疗法，并促进新兴基础科学发现应用于临床 调查事务所我们相信，杜克RCC是非常有能力作出贡献的成功 这些目标的实现基于开发原创，创新， 高影响力的临床研究协议，解决心脏临床重要研究问题 失败，并提出了一种新的协议，针对急性心力衰竭患者，CAPTAIN研究，在这方面， 应用程序.杜克大学RCC已经证明有能力招募科学上合适的和种族上合适的人， 将不同种族的患者人群纳入HF网络临床方案，并提供 准确、完整、及时且符合法规要求。如本提案所述，杜克RCC已 一个专门和经验丰富的研究团队，结合了广泛的临床，研究， 操作技能，这些技能将共同对HF的整体成功做出重大贡献 网络我们将参与杜克RCC研究方案的制定，统计 数据收集和方案实施的方法和计划。我们将提供输入， 从科学和可行性的角度来看，适当地纳入研究设计。落实 方案审查委员会（PRC）和NHLBI批准的每个网络范围方案;遵守 指导委员会批准的研究政策和质量保证措施，并同意 由数据和安全性监查委员会（DSMB）对研究进行监督。最后，杜克RCC将 开发临床研究技能开发核心，以培训未来的心力衰竭患者 研究人员 相关性（参见说明）： NHLBI心力衰竭临床研究杜克地区临床中心的提案 网络将开发和实施高影响力，科学严谨的随机临床试验 旨在改善心力衰竭患者的健康状况。拟议研究的结果 将对数百万心力衰竭患者产生直接的临床影响。