The Impact of COVID-19
on Clinical Research



What is the

Heart Failure Collaboratory (HFC)?

Efficiency of clinical trials and evidence generation in heart failure and foster development of therapies by creating a collaborative environment in which FDA, government agencies including NIH and CMS, and the heart failure community can interact to optimize innovation and advancement of new therapeutic products. HFC has established five working groups to tackle individual issues in clinical trials and fostering the development of effective heart failure therapies.

The Heart Failure Collaboratory is a public-private partnership with the FDA and the consortium to help foster the development of new products for heart failure.

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Recent Publications

Access our latest publications, downloads and meeting notes.
Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week
With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.
Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials--A Call to Action From the Heart Failure Collaboratory
Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may even introduce uncertainties and hesitancy when translating trial data to the care of people from underrepresented groups.
Functional and Symptomatic Clinical Endpoints in Heart Failure Research: Insights from the Heart Failure Collaboratory Academic Research Consortium (HF ARC) Scientific Expert Panel
Increased use of functional and symptomatic endpoints, along with the ability to remotely capture them, has the potential to improve the efficiency of HF clinical trials in a patient-centered manner. We summarize expert consensus recommendations for use of these metrics in clinical trials and frameworks for their continued evolution.