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: 8600722
• 负责人: GARY M FELKER
• 金额: $ 50.55万
• 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 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8600722
• 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; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collaborations; Commit; Communities; 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; Metric; 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; cost effectiveness; design; effectiveness research; 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.

合成的 项目摘要 杜克大学医学中心地区临床提案的推翻目标 心力衰竭临床研究网络（HF网络）的中心（RCC）是改善 通过高影响患者的临床研究来护理心力衰竭的患者。这个目标 将通过与HF网络的所有组件的积极合作来实现，包括其他 RCC，数据协调中心（DCC），关联的核心实验室和NHLBI。总体目标 HF网络是通过最佳应用现有疗法来改善结果，评估 新型疗法，并促进新兴的基础科学发现在临床上 调查。我们认为，公爵RCC有能力为成功做出贡献 基于开发原始，创新的记录，实现这些目标的实现 高影响临床研究方案解决心脏中临床上重要的研究问题 失败，并提出了针对急性心力衰竭患者的新型方案，这是船长的研究 应用。公爵RCC已被证明具有科学和种族适当的招募能力 种族多样化的患者人群进入HF网络临床方案，并提供数据 准确，完整，及时且符合法规规定。正如该提案中详细介绍的那样，杜克RCC拥有 一个专门的调查人员团队，结合了各种各样的临床，研究和 将共同为HF的整体成功做出重大贡献的运营技能 网络。我们将参加研究协议的制定，统计 方法以及数据收集和协议实施的计划。我们将提供输入 从科学和可行性的角度适当地进行研究设计。我们将实施 协议审查委员会（PRC）和NHLBI批准的每个网络范围的协议；遵守 通过指导委员会批准的研究政策和质量保证措施，并同意 通过数据和安全监控委员会（DSMB）对研究进行监督。最后，公爵RCC将 开发临床研究技能发展核心，以训练子孙后代的心力衰竭 研究人员。 相关性（请参阅Instnjctions）： 这项关于NHLBI心力衰竭临床研究的杜克大学地区临床中心的建议 网络将开发和实施高影响，科学严格的随机临床试验 旨在改善心力衰竭的人的健康。拟议研究的结果 将立即对数百万心力衰竭患者产生临床意义。