Cardiac Safety Research ConsortiumCentralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: A report from the Cardiac Safety Research Consortium
Section snippets
The challenges of CV end point assessments
Clinical investigators with similar training who work at the same institution can genuinely (and legitimately) disagree about the definition of an individual CV end point event. When this scenario is extended to the context of a CV outcome trial (CVOT), where participants must be recruited from several investigational sites encompassing a variety of geographies, cultures, and clinical care standards, it is highly likely that this diversity of interpretation increases. Adjudication of end points
Disclosures
Jonathan H. Seltzer, MD, MBA, MA, FACC, is an employee and stockholder of ACI Clinical, LLC. His financial disclosures can be viewed at http://www.aciclinical.com/disclosure.aspx. He is a member of the CSRC Planning Committee.
J. Rick Turner, PhD, is an employee of Quintiles and a member of the CSRC Executive Committee.
Mary Jane Geiger, MD, PhD, is an employee of Regeneron Pharmaceuticals, Inc.
Giuseppe Rosano, MD, PhD, is an employee of St. George’s University.
Kenneth W. Mahaffey, MD, FACC, is
Acknowledgements
We thank G. Molly Campbell, BA, of ACI Clinical for her assistance in the preparation and editing of manuscript.
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