Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.

Journal Article (Journal Article;Review)

The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members. A series of meetings were convened to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish key recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure. This paper summarizes the discussions and expert consensus recommendations.

Full Text

Duke Authors

Cited Authors

  • Psotka, MA; Abraham, WT; Fiuzat, M; Filippatos, G; Lindenfeld, J; Ahmad, T; Bhatt, AS; Carson, PE; Cleland, JGF; Felker, GM; Januzzi, JL; Kitzman, DW; Leifer, ES; Lewis, EF; McMurray, JJV; Mentz, RJ; Solomon, SD; Stockbridge, N; Teerlink, JR; Vaduganathan, M; Vardeny, O; Whellan, DJ; Wittes, J; Anker, SD; O'Connor, CM

Published Date

  • November 17, 2020

Published In

Volume / Issue

  • 76 / 20

Start / End Page

  • 2368 - 2378

PubMed ID

  • 33183511

Pubmed Central ID

  • PMC7836888

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2020.09.544

Language

  • eng

Conference Location

  • United States