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

Publication ,  Journal Article
Piccini, JP; Clark, RL; Kowey, PR; Mittal, S; Dunnmon, P; Stockbridge, N; Reiffel, JA; Turakhia, MP; Ziegler, PD; Kleiman, RB; Ismat, F; Sager, P
Published in: Am Heart J
May 2017

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.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

May 2017

Volume

187

Start / End Page

156 / 169

Location

United States

Related Subject Headings

  • Humans
  • Electrocardiography
  • Drug Monitoring
  • Drug Evaluation
  • Cardiovascular System & Hematology
  • Arrhythmias, Cardiac
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
  • 1102 Cardiorespiratory Medicine and Haematology
 

Citation

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Piccini, J. P., Clark, R. L., Kowey, P. R., Mittal, S., Dunnmon, P., Stockbridge, N., … Sager, P. (2017). Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium. Am Heart J, 187, 156–169. https://doi.org/10.1016/j.ahj.2017.01.012
Piccini, Jonathan P., Richard L. Clark, Peter R. Kowey, Suneet Mittal, Preston Dunnmon, Norman Stockbridge, James A. Reiffel, et al. “Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium.Am Heart J 187 (May 2017): 156–69. https://doi.org/10.1016/j.ahj.2017.01.012.
Piccini JP, Clark RL, Kowey PR, Mittal S, Dunnmon P, Stockbridge N, et al. Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium. Am Heart J. 2017 May;187:156–69.
Piccini, Jonathan P., et al. “Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium.Am Heart J, vol. 187, May 2017, pp. 156–69. Pubmed, doi:10.1016/j.ahj.2017.01.012.
Piccini JP, Clark RL, Kowey PR, Mittal S, Dunnmon P, Stockbridge N, Reiffel JA, Turakhia MP, Ziegler PD, Kleiman RB, Ismat F, Sager P. Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium. Am Heart J. 2017 May;187:156–169.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

May 2017

Volume

187

Start / End Page

156 / 169

Location

United States

Related Subject Headings

  • Humans
  • Electrocardiography
  • Drug Monitoring
  • Drug Evaluation
  • Cardiovascular System & Hematology
  • Arrhythmias, Cardiac
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
  • 1102 Cardiorespiratory Medicine and Haematology