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
Language
- eng
Conference Location
- United States