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

James L Januzzi Jr; 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

doi:10.1016/j.jacc.2021.02.040

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

J Am Coll Cardiol. 2021 Apr 20;77(15):1922-1933. doi: 10.1016/j.jacc.2021.02.040.

Authors

James L Januzzi Jr¹, John M Canty², Saumya Das³, Christopher R DeFilippi⁴, Gary A Gintant⁵, David E Gutstein⁶, Allan Jaffe⁷, Emily P Kaushik⁸, Christopher Leptak⁹, Cyrus Mehta¹⁰, Ileana Pina¹¹, Thomas J Povsic¹², Curtis Rambaran¹³, Rhonda F Rhyne¹⁴, Maribel Salas¹⁵, Victor C Shi¹⁶, Jacob A Udell¹⁷, Ellis F Unger¹⁸, Tanja S Zabka¹⁹, Jonathan H Seltzer²⁰

Affiliations

¹ Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; Baim Institute for Clinical Research, Boston, Massachusetts, USA. Electronic address: jjanuzzi@partners.org.
² Division of Cardiovascular Medicine, University at Buffalo and Department of Veterans Affairs, Western New York Health Care System, Buffalo, New York, USA.
³ Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
⁴ Inova Heart and Vascular Institute, Falls Church, Virginia, USA.
⁵ Department of Integrative Pharmacology, Integrated Sciences and Technology, AbbVie Pharmaceuticals, Cambridge, Massachusetts, USA.
⁶ Cardiovascular Metabolism Discovery, Janssen Pharmaceuticals, Titusville, New Jersey, USA.
⁷ Department of Cardiovascular Diseases and Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
⁸ Global Drug Safety Research and Evaluation, Takeda Pharmaceuticals, Boston, Massachusetts, USA.
⁹ Biomarker Qualification Program, Office New Drugs, Center for Drug Development and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.
¹⁰ Harvard TH Chan School of Public Health and Cytel Inc., Boston, Massachusetts, USA.
¹¹ Wayne State University, Detroit, Michigan, USA.
¹² Duke Clinical Research Institute and Department of Medicine, Duke University, Durham, North Carolina, USA.
¹³ Daiichi-Sankyo, Inc., Basking Ridge, New Jersey, USA.
¹⁴ Prevencio, Inc., Kirkland, Washington, USA.
¹⁵ Daiichi-Sankyo, Inc., Basking Ridge, New Jersey, USA; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
¹⁶ Novartis Pharmaceuticals Corporation, Basel, Switzerland.
¹⁷ Cardiovascular Division, Women's College Hospital and Peter Munk Cardiac Centre, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.
¹⁸ Office of Cardiology, Hematology, Endocrinology, and Nephrology, Office of New Drugs, Center for Drug Development and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.
¹⁹ Development Sciences-Safety Assessment, Genentech Inc., San Francisco, California, USA.
²⁰ WCG Clinical and WCG-ACI Clinical, Bala Cynwood, Pennsylvania, USA.

PMID: 33858628
DOI: 10.1016/j.jacc.2021.02.040

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.

Keywords: biobanking; biomarker; clinical trials.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Biomarkers / analysis*
Cardiovascular Diseases / diagnosis*
Cardiovascular Diseases / drug therapy
Clinical Trials as Topic / standards*
Drug Discovery
Humans
Precision Medicine
Prognosis
Treatment Outcome

Substances

Biomarkers