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

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • 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 Date

  • May 2017

Published In

Volume / Issue

  • 187 /

Start / End Page

  • 156 - 169

PubMed ID

  • 28454799

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2017.01.012


  • eng

Conference Location

  • United States