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

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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.