Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium

被引：10

作者：

Piccini, Jonathan P. ^{[1
,2
]}

Clark, Richard L. ^{[3
]}

Kowey, Peter R. ^{[4
,5
]}

Mittal, Suneet ^{[6
]}

Dunnmon, Preston ^{[7
]}

Stockbridge, Norman ^{[7
]}

Reiffel, James A. ^{[8
]}

Turakhia, Mintu P. ^{[9
,10
]}

Ziegler, Paul D. ^{[3
]}

Kleiman, Robert B. ^{[11
]}

Ismat, Fraz ^{[12
]}

Sager, Philip ^{[13
]}

机构：

[1] Duke Univ, Med Ctr, Durham, NC 27708 USA

[2] Duke Clin Res Inst, Durham, NC 27705 USA

[3] Mechron Diagnost & Monitoring Res, Mounds View, MN USA

[4] Lankenau Heart Inst, Philadelphia, PA USA

[5] Jefferson Med Coll, Philadelphia, PA USA

[6] Valley Hlth Syst, Ridgewood, NJ USA

[7] US FDA, Div Cardiovasc & Renal Prod, Rockville, MD 20857 USA

[8] Columbia Univ, Div Cardiol, Med Ctr, New York, NY USA

[9] VA Palo Alto Hlth Care Syst, Palo Alto, CA USA

[10] Stanford Univ, Palo Alto, CA 94304 USA

[11] eRes Technol Inc ERT, Philadelphia, PA USA

[12] Bristol Myers Squibb, Princeton, NJ USA

[13] Stanford Univ, Stanford, CA 94305 USA

来源：

AMERICAN HEART JOURNAL | 2017年 / 187卷

关键词：

ATRIAL-FIBRILLATION; PROARRHYTHMIC RISK; HEPATITIS-C; SOFOSBUVIR; ARRHYTHMIAS; AMIODARONE; DEVICES; FOCUS;

D O I：

10.1016/j.ahj.2017.01.012

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

This white paper, prepared by members of the Cardiac Safety Research Consortium (CSRC), discusses important issues regarding scientific and clinical aspects of long-term electrocardiographic safety monitoring during clinical drug development. To promote multistakeholder discussion of this topic, a Cardiac Safety Research Consortium sponsored Think Tank was held on 2 December 2015 at the American College of Cardiology's Heart House in Washington, DC. The goal of the Think Tank was to explore how and under what circumstances new and evolving ambulatory monitoring technologies could be used to improve and streamline drug development. This paper provides a detailed summary of discussions at the Think Tank: it does not represent regulatory guidance.

引用

页码：156 / 169

页数：14

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