Gaining Efficiency in Clinical Trials With Cardiac Biomarkers

被引：8

作者：

Januzzi, James L., Jr. ^{[1
,2
]}

Canty, John M. ^{[3
,4
]}

Das, Saumya ^{[1
]}

DeFilippi, Christopher R. ^{[5
]}

Gintant, Gary A. ^{[6
]}

Gutstein, David E. ^{[7
]}

Jaffe, Allan ^{[8
,9
]}

Kaushik, Emily P. ^{[10
]}

Leptak, Christopher ^{[11
]}

Mehta, Cyrus ^{[12
,13
]}

Pina, Ileana ^{[14
]}

Povsic, Thomas J. ^{[15
,16
]}

Rambaran, Curtis ^{[17
]}

Rhyne, Rhonda F. ^{[18
]}

Salas, Maribel ^{[17
,19
]}

Shi, Victor C. ^{[20
]}

Udell, Jacob A. ^{[21
,22
]}

Unger, Ellis F. ^{[23
]}

Zabka, Tanja S. ^{[24
]}

Seltzer, Jonathan H. ^{[25
]}

机构：

[1] Harvard Med Sch, Massachusetts Gen Hosp, Cardiol Div, Boston, MA 02115 USA

[2] Baim Inst Clin Res, Boston, MA USA

[3] Univ Buffalo, Div Cardiovasc Med, Buffalo, NY USA

[4] Western New York Hlth Care Syst, Dept Vet Affairs, Buffalo, NY USA

[5] Inova Heart & Vasc Inst, Falls Church, VA USA

[6] AbbVie Pharmaceut, Dept Integrat Pharmacol Integrated Sci & Technol, Cambridge, MA USA

[7] Janssen Pharmaceut, Cardiovasc Metab Discovery, Titusville, NJ USA

[8] Mayo Clin, Dept Cardiovasc Dis, Rochester, MN USA

[9] Mayo Clin, Lab Med & Pathol, Rochester, MN USA

[10] Takeda Pharmaceut, Global Drug Safety Res & Evaluat, Boston, MA USA

[11] US FDA, Biomarker Qualificat Program, Off New Drugs, Ctr Drug Dev & Res, Silver Spring, MD USA

[12] Harvard TH Chan Sch Publ Hlth, Boston, MA USA

[13] Cytel Inc, Boston, MA USA

[14] Wayne State Univ, Detroit, MI USA

[15] Duke Univ, Duke Clin Res Inst, Durham, NC USA

[16] Duke Univ, Dept Med, Durham, NC USA

[17] Daiichi Sankyo Inc, Basking Ridge, NJ USA

[18] Prevencio Inc, Kirkland, WA USA

[19] Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA

[20] Novartis Pharmaceut, Basel, Switzerland

[21] Univ Toronto, Womens Coll Hosp, Cardiovasc Div, Toronto, ON, Canada

[22] Univ Toronto, Toronto Gen Hosp, Peter Munk Cardiac Ctr, Toronto, ON, Canada

[23] US FDA, Off Cardiol Hematol Endocrinol & Nephrol, Off New Drugs, Ctr Drug Dev & Res, Silver Spring, MD USA

[24] Genentech Inc, Dev Sci Safety Assessment, 460 Point San Bruno Blvd, San Francisco, CA 94080 USA

[25] WCG Clin & WCG ACI Clin, Bala Cynwood, PA USA

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2021年 / 77卷 / 15期

关键词：

biomarker; clinical trials; biobanking; ROSUVASTATIN MULTINATIONAL TRIAL; BRAIN NATRIURETIC PEPTIDE; SAMPLED BLOOD ARCHIVE; HEART-FAILURE; CORONARY; THERAPY; ANGIOGRAPHY; PREDICTION; SURVIVAL; BENEFIT;

D O I：

10.1016/j.jacc.2021.02.040

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1922 / 1933

页数：12

共 50 条

[31] Prognostication of clinical outcomes in diabetes mellitus: Emerging role of cardiac biomarkers
Berezin, Alexander E.
DIABETES & METABOLIC SYNDROME-CLINICAL RESEARCH & REVIEWS, 2019, 13 (02) : 995 - 1003
[32] Evaluation of clinical assessments of social abilities for use in autism clinical trials by the autism biomarkers consortium for clinical trials
Faja, Susan
Sabatos-DeVito, Maura
Sridhar, Aksheya L.
Kuhn, Jocelyn L.
Nikolaeva, Julia I.
Sugar, Catherine A.
Webb, Sara Jane
Bernier, Raphael A.
Sikich, Linmarie
Hellemann, Gerhard
Senturk, Damla
Naples, Adam J.
Shic, Frederick
Levin, April R.
Seow, Helen A.
Dziura, James D.
Jeste, Shafali S.
Chawarska, Katarzyna
Nelson, Charles A., III
Dawson, Geraldine
McPartland, James C.
AUTISM RESEARCH, 2023, 16 (05) : 981 - 996
[33] Cardiac Biomarkers in Patients with Cancer: Considerations, Clinical Implications, and Future Avenues
Bracun, Valentina
Aboumsallem, Joseph Pierre
van der Meer, Peter
de Boer, Rudolf A.
CURRENT ONCOLOGY REPORTS, 2020, 22 (07)
[34] Clinical Diagnostic Biomarkers from the Personalization of Computational Models of Cardiac Physiology
Lamata, Pablo
Cookson, Andrew
Smith, Nic
ANNALS OF BIOMEDICAL ENGINEERING, 2016, 44 (01) : 46 - 57
[35] Panvigilance: Integrating Biomarkers in Clinical Trials for Systems Pharmacovigilance
Sardas, Semra
Kendirci, Asliguel
OMICS-A JOURNAL OF INTEGRATIVE BIOLOGY, 2019, 23 (03) : 134 - 137
[36] The Role of Biomarkers in Clinical Trials of Inflammatory Bowel Disease
Khanna, Reena
Narula, Neeraj
Feagan, Brian G.
INFLAMMATORY BOWEL DISEASES, 2018, 24 (08) : 1619 - 1623
[37] The application of biomarkers in clinical trials for motor neuron disease
Ganesalingam, I.
Bowser, R.
BIOMARKERS IN MEDICINE, 2010, 4 (02) : 281 - 297
[38] Biomarkers in Cardiomyopathies and Prediction of Sudden Cardiac Death
Kruska, Mathieu
El-Battrawy, Ibrahim
Behnes, Michael
Borggrefe, Martin
Akin, Ibrahim
CURRENT PHARMACEUTICAL BIOTECHNOLOGY, 2017, 18 (06) : 472 - 481
[39] Stem cells clinical trials for cardiac repair: regulation as practical accomplishment
Wilson-Kovacs, Dana M.
Weber, Susanne
Hauskeller, Christine
SOCIOLOGY OF HEALTH & ILLNESS, 2010, 32 (01) : 89 - 105
[40] Biomarkers as Endpoints in Clinical Trials for Alzheimer's Disease
Elghanam, Yomna
Purja, Sujata
Kim, Eun Young
JOURNAL OF ALZHEIMERS DISEASE, 2024, 99 (02) : 693 - 703

← 1 2 3 4 5 →