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 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.
Duke Scholars
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- 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
Published In
DOI
EISSN
Publication Date
Volume
Start / End Page
Location
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