Heart Failure Collaboratory

The Heart Failure Collaboratory (HFC) is a consortium of stakeholders and a public-private partnership with FDA, committed to improving the ecosystem of heart failure research. Originating from a think-tank in 2017, the Collaboratory consists of five working groups—each with the goal of tackling issues related to the efficiency of clinical trials and fostering the development of effective heart failure therapies. Digital Health and Technologies: developing processes for the utilization of digital technology to enhance clinical trial enrollment, integrating the electronic medical record (EMR) into research-friendly applications, and promoting policies to enhance evidence-generation using the EMR and other digital tools. Regulatory Policy and Implementation Science—Drugs: focused on reducing the regulatory burden on drug development, identifying methods of communication to ensure industry receives information in a timely and interpretable fashion, and developing methods to unify the ecosystem of regulatory approval and post-approval utilization. Regulatory Policy and Implementation Science—Devices: focused on reducing the regulatory burden on device development, identifying methods of communication to ensure industry receives information in a timely and interpretable fashion, and developing methods to unify the ecosystem of regulatory approval and post-approval utilization. Research Culture, Networks, and the Roles of Societies: focused on streamlining research processes including developing and operationalizing site networks, utilizing society networks, and collaborating with patient-centered resources to build patient research networks and patient resources for clinical trials. Representative Populations: developing standards of representative populations for trials based on epidemiology by heart failure phenotype, and novel methods of recruiting these patient cohorts in clinical trials.