The COVID-19 pandemic has greatly affected the conduct of clinical trials. Recommendations to support ongoing heart failure clinical trials and strengthen the clinical trial ecosystem were published Nov. 9 in the Journal of the American College of Cardiology.

Mitchell A. Psotka, MD, PhD, FACC, and representatives from the Heart Failure Academic Research Consortium – a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the U.S. and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members – sought to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure.

The statement outlines general principles for conducting clinical research during and following the current pandemic. Among other recommendations, the authors suggest that "[sponsors] and regulators must together decide which protocol procedures can be safely and accurately completed and which data are critical, and seek to maximize evidence acquisition while embracing flexibility, including protocol amendments and deviations when appropriate."

The authors also provide recommendations on data and trial integrity, socioeconomic disparities, statistical considerations, and endpoint collection, including patient-reported outcomes and quality-of-life assessments, functional and exercise measures, imaging, biomarkers, hospitalization and mortality endpoints, and adverse events.

"[These] principles should also be incorporated into contingency planning for future public health crises and systemic disruptions, including potential resurgence of COVID-19, to allow more seamless continuation of clinical research," write the authors. "Although some clinical research programs may unfortunately be substantially adversely affected by COVID-19, we hope our suggestions will help salvage ongoing clinical investigation and strengthen the clinical trial environment for the future."

In addition, JACC: Heart Failure recently co-published “Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium” with the European Journal of Heart Failure.

Outlined in the paper are standardized expert consensus definitions developed by the Heart Failure Academic Research Consortium that are intended to improve uniformity and comparability within and across heart failure clinical trials. “The heart failure clinical research community is encouraged to utilize these definitions and endpoints established by our multi-stakeholder collaboration with academia, patients, industry representatives, regulators, and payors,” write William T. Abraham, MD, FACC, et al.

Clinical Topics: COVID-19 Hub, Heart Failure and Cardiomyopathies, Acute Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: COVID-19, Pandemics, Coronavirus, severe acute respiratory syndrome coronavirus 2, Cardiovascular Diseases, Public Health, Quality of Life, Ecosystem, United States Food and Drug Administration, Heart Failure, Hospitalization, National Institutes of Health (U.S.), Research Personnel, Cardiology, Biomarkers

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