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

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.
Competing Interests: Funding Support and Author Disclosures Dr. Januzzi is supported in part by the Hutter Family Professorship; has served as a Trustee of the American College of Cardiology; is a board member of Imbria Pharmaceuticals; has received grant support from Applied Therapeutics, Innolife, Novartis Pharmaceuticals, and Abbott Diagnostics; has received consulting income from Abbott, Janssen, Novartis, and Roche Diagnostics; and has participated in clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, Amgen, Bayer, CVRx, Janssen, MyoKardia, and Takeda. Dr. Gintant is an employee of AbbVie, Inc. Dr. Gutstein is an employee of Janssen Pharmaceuticals. Dr. Jaffe has consulted or presently consults for most of the major diagnostics companies, including Beckman, Abbott, Siemens, ET Healthcare, Roche, Quidel, Sphingotec, Brava, Blade, and Novartis. Dr. Kaushik is an employee of Takeda Pharmaceuticals. Drs. Rambaran and Salas are employees of Daiichi-Sankyo, Inc. Ms. Rhyne is an employee of Prevencio, Inc. Dr. Shi is an employee of Novartis Pharmaceuticals, Inc. Dr. Udell has received grant support to his institutions from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Janssen, Novartis, and Sanofi; and has received speaker/consulting honoraria from Amgen, Boehringer Ingelheim, Novartis, and Sanofi. Dr. Zabka is an employee of Genentech, Inc. Dr. Seltzer is an employee of WCG Clinical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The opinions expressed in this publication reflect those of the authors and do not necessarily reflect the positions or thinking of the U.S. Food and Drug Administration.
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