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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)

基本信息

批准号：
8403731
负责人：
GARY M FELKER
金额：
$ 50.57万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
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/8403731
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&apos s Degree Measures Metric Morbidity - disease rate National Heart, Lung, and Blood Institute Outcome Participant Patient Care Patient Recruitments Patients Performance Persons Policies Population 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 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

项目摘要

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.

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