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

doi:10.1016/j.jacc.2021.02.040

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

Cardiovascular Medicine

Research output: Contribution to journal › Review article › peer-review

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 language	English (US)
Pages (from-to)	1922-1933
Number of pages	12
Journal	Journal of the American College of Cardiology
Volume	77
Issue number	15
DOIs	https://doi.org/10.1016/j.jacc.2021.02.040
State	Published - Apr 20 2021

Keywords

biobanking
biomarker
clinical trials

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jacc.2021.02.040

Cite this

Januzzi, J. L., Canty, J. M., Das, S., DeFilippi, C. R., Gintant, G. A., Gutstein, D. E., Jaffe, A., Kaushik, E. P., Leptak, C., Mehta, C., Pina, I., Povsic, T. J., Rambaran, C., Rhyne, R. F., Salas, M., Shi, V. C., Udell, J. A., Unger, E. F., Zabka, T. S., & Seltzer, J. H. (2021). Gaining Efficiency in Clinical Trials With Cardiac Biomarkers: JACC Review Topic of the Week. Journal of the American College of Cardiology, 77(15), 1922-1933. https://doi.org/10.1016/j.jacc.2021.02.040

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 2021, 'Gaining Efficiency in Clinical Trials With Cardiac Biomarkers: JACC Review Topic of the Week', Journal of the American College of Cardiology, vol. 77, no. 15, pp. 1922-1933. https://doi.org/10.1016/j.jacc.2021.02.040

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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.",

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AU - Pina, Ileana

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AU - Rambaran, Curtis

AU - Rhyne, Rhonda F.

AU - Salas, Maribel

AU - Shi, Victor C.

AU - Udell, Jacob A.

AU - Unger, Ellis F.

AU - Zabka, Tanja S.

AU - Seltzer, Jonathan H.

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

Abstract

Keywords

ASJC Scopus subject areas

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