Gaining Efficiency in Clinical Trials With Cardiac Biomarkers

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:77

Article

Januzzi, James L., Jr.^1,2  Canty, John M.^3,4  Das, Saumya¹  DeFilippi, Christopher R.⁵  Gintant, Gary A.⁶  Gutstein, David E.⁷  Jaffe, Allan^8,9  Kaushik, Emily P.¹⁰  Leptak, Christopher¹¹  Mehta, Cyrus^12,13  Pina, Ileana¹⁴  Povsic, Thomas J.^15,16  Rambaran, Curtis¹⁷  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 

[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

关键词: biomarker;    clinical trials;    biobanking;   

DOI  :  10.1016/j.jacc.2021.02.040

来源: Elsevier

【 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.

【 授权许可】

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