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

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • Januzzi, JL; Canty, JM; Das, S; DeFilippi, CR; Gintant, GA; Gutstein, DE; Jaffe, A; Kaushik, EP; Leptak, C; Mehta, C; Pina, I; Povsic, TJ; Rambaran, C; Rhyne, RF; Salas, M; Shi, VC; Udell, JA; Unger, EF; Zabka, TS; Seltzer, JH

Published Date

  • April 20, 2021

Published In

Volume / Issue

  • 77 / 15

Start / End Page

  • 1922 - 1933

PubMed ID

  • 33858628

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2021.02.040

Language

  • eng

Conference Location

  • United States