Long-term Electrocardiographic Safety Monitoring in Clinical Drug Development: A Report from the Cardiac Safety Research Consortium

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 multi-stakeholder discussion of this topic, a...

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Bibliographic Details
Published in:The American heart journal 2017-05, Vol.187, p.156-169
Main Authors: Piccini, Jonathan P, Clark, Richard L, Kowey, Peter R, Mittal, Suneet, Dunmon, Preston, Stockbridge, Norman, Reiffel, James A, Turakhia, Mintu P, Ziegler, Paul D, Kleiman, Robert B, Ismat, Fraz, Sager, Philip
Format: Article
Language:English
Subjects:
Arrhythmias, Cardiac - chemically induced
Cardiac arrhythmia
Cardiology
Cardiovascular
Cardiovascular disease
Clinical aspects
Clinical trials
Consortia
Critical path
Drug development
Drug dosages
Drug Evaluation
Drug Monitoring - methods
Electrocardiography
Electrocardiography - instrumentation
Electrocardiography - methods
Gastroenterology
Heart
Heart diseases
Heart rate
Hepatitis
Humans
Monitoring
Patients
Product safety
Safety
Safety research
Skin
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Summary: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 multi-stakeholder discussion of this topic, a CSRC-sponsored Think Tank was held on 2nd 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.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2017.01.012