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Am Heart J. 2015 Apr;169(4):486-95. doi: 10.1016/j.ahj.2015.01.007. Epub 2015 Jan 15.

Cardiovascular Safety Outcome Trials: A meeting report from the Cardiac Safety Research Consortium.

Author information

1
Stanford University School of Medicine, Palo Alto, CA.
2
ACI Clinical, Bala Cynwyd, PA.
3
Quintiles, Inc, Durham, NC.
4
Intermountain Heart Institute, Salt Lake City, UT.
5
Division of Cardiology/CPC Clinical Research, University of Colorado School of Medicine, Aurora, CO.
6
Lankenau Medical Center, Philadelphia, PA.
7
Stanford Prevention Research Center, Stanford University, Palo Alto, CA.
8
Food and Drug Administration, Silver Spring MD.
9
Cardiology Center, University of Connecticut School of Medicine, Farmington, CT. Electronic address: wwhite@uchc.edu.

Abstract

This White Paper provides a summary of presentations and discussions at a Cardiovascular Safety Outcome Trials Think Tank cosponsored by the Cardiac Safety Research Consortium, the US Food and Drug Administration, and the American College of Cardiology, held at American College of Cardiology's Heart House, Washington, DC, on February 19, 2014. Studies to assess cardiovascular (CV) risk of a new drug are sometimes requested by regulators to resolve ambiguous safety signals seen during its development or among other members of its class. Think Tank participants thought that important considerations in undertaking such studies were as follows: (1) plausibility-how likely it is that a possible signal indicating risk is real, based on strength of evidence, and/or whether a plausible mechanism of action for potential CV harm has been identified; (2) relevance-what relative and absolute CV risk would need to be excluded to determine that the drug had an acceptable benefit-to-risk balance for its use in the intended patient population; and (3) how plausibility and relevance influence the timing and approach to further safety assessment.

PMID:
25819855
DOI:
10.1016/j.ahj.2015.01.007
[Indexed for MEDLINE]
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