The Heart Failure Collaboratory Public-Private Partnership Between the United States Food and Drug Administration, the Inova Heart and Vascular Institute, and the Heart Failure Community

美国食品和药物管理局、Inova 心脏和血管研究所以及心力衰竭社区之间的心力衰竭合作公私合作伙伴关系

• 批准号: 10087166
• 负责人: CHRISTOPHER M O'CONNOR
• 金额: $ 14.9万
• 依托单位: INOVA HEALTH CARE SERVICES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-10 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10087166
• 关键词: Heart; Failure; Collaboratory; Public; Private

The Heart Failure Collaboratory (HFC) is a public-private partnership between the Inova Heart and Vascular Institute (IHVI), the United States Food and Drug Administration (FDA), and the major stakeholders in the heart failure (HF) community, including patients, clinical investigators, academic leaders, pharmaceutical and device industry representatives, society representatives, third party payers, and government representatives from the United States National Institutes of Health (NIH) and Centers for Medicare and Medicaid Services (CMS). The HFC aims to advance scientific discussion, efficiency of clinical trials and evidence generation for HF, and foster development of therapies; to achieve these goals the HFC creates a collaborative environment in which FDA, government agencies including NIH and CMS, and the HF community can interact to optimize innovation and advancement of new therapeutic products. This proposal describes how the HFC executive committee, led by the program chair and principal investigator, in coordination with the HFC working groups, will continue to discuss and develop solutions to identified obstacles within the HF ecosystem. These include but are not limited to refining clinical trial endpoint definitions, facilitating standardized data collection and analyses, streamlining clinical trial performance by utilizing novel digital and automatic mechanisms, establishing systems to reward individuals, organizations, and networks with shared goals and dedication to advancing HF treatment, nurturing inclusion of patients and particularly those of diverse populations in all aspects of clinical research, and developing new diverse clinical research leaders and investigators. This application outlines the organizational infrastructure and support to be provided as the HFC strides into the future to overcome barriers to the development and implementation of new therapeutic interventions for patients with HF. It builds upon the initial successes of the public-private partnership between the FDA and IHVI administering the HFC, and further boosts the impact of the HFC to enhance clinical trial efficiency, therapeutic development, and patient wellbeing.

心力衰竭合作实验室（HFC）是Inova Heart和 血管研究所（IHVI），美国食品和药物管理局（FDA），以及主要的 心力衰竭（HF）社区的利益相关者，包括患者、临床研究者、学术界 领导、医药器械行业代表、学会代表、第三方 付款人和美国国立卫生研究院（NIH）的政府代表 医疗保险和医疗补助服务中心（CMS）。HFC旨在推进科学 讨论，临床试验的效率和HF的证据生成，并促进 治疗;为了实现这些目标，HFC创造了一个合作环境，FDA， 包括NIH和CMS在内的政府机构和HF社区可以相互作用， 创新和发展新的治疗产品。该提案描述了HFC如何 执行委员会，由项目主席和首席研究员领导，与HFC协调 工作组将继续讨论和制定解决方案，以解决HF内部已确定的障碍 生态系统这些包括但不限于完善临床试验终点定义，促进 标准化的数据收集和分析，通过利用新的 数字化和自动化机制，建立奖励个人、组织和 具有共同目标的网络，致力于推进HF治疗，培养患者的包容性 特别是在临床研究的各个方面， 不同的临床研究领导者和研究者。此应用程序概述了组织 随着氢氟碳化合物向未来迈进， 为HF患者开发和实施新的治疗干预措施。它建立 在FDA和IHVI管理之间的公私伙伴关系取得初步成功后， 氢氟碳化合物，并进一步增强氢氟碳化合物的影响，以提高临床试验效率、治疗效果 发展和患者福祉。