Gaining Efficiency in Clinical Trials With Cardiac Biomarkers: JACC Review Topic of the Week

James L. Januzzi, John M. Canty, Saumya Das, Christopher R. DeFilippi, Gary A. Gintant, David E. Gutstein, Allan Jaffe, Emily P. Kaushik, Christopher Leptak, Cyrus Mehta, Ileana Pina, Thomas J. Povsic, Curtis Rambaran, Rhonda F. Rhyne, Maribel Salas, Victor C. Shi, Jacob A. Udell, Ellis F. Unger, Tanja S. Zabka, Jonathan H. Seltzer

Research output: Contribution to journalReview articlepeer-review

3 Scopus citations

Abstract

The momentum of cardiovascular drug development has slowed dramatically. Use of validated cardiac biomarkers in clinical trials could accelerate development of much-needed therapies, but biomarkers have been used less for cardiovascular drug development than in therapeutic areas such as oncology. Moreover, there are inconsistences in biomarker use in clinical trials, such as sample type, collection times, analytical methods, and storage for future research. With these needs in mind, participants in a Cardiac Safety Research Consortium Think Tank proposed the development of international guidance in this area, together with improved quality assurance and analytical methods, to determine what biomarkers can reliably show. Participants recommended the development of systematic methods for sample collection, and the archiving of samples in all cardiovascular clinical trials (including creation of a biobank or repository). The academic and regulatory communities also agreed to work together to ensure that published information is fully and clearly expressed.

Original languageEnglish
Pages (from-to)1922-1933
Number of pages12
JournalJournal of the American College of Cardiology
Volume77
Issue number15
DOIs
StatePublished - 20 Apr 2021
Externally publishedYes

Keywords

  • biobanking
  • biomarker
  • clinical trials

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