Endpoint Definitions in Clinical Trials: Consensuses, A Synonym for Dissensuses?

Gabor G Toth; William Wijns

doi:10.1016/j.jcin.2019.01.229

Endpoint Definitions in Clinical Trials: Consensuses, A Synonym for Dissensuses?

JACC Cardiovasc Interv. 2019 May 13;12(9):885-889. doi: 10.1016/j.jcin.2019.01.229.

Authors

Gabor G Toth¹, William Wijns²

Affiliations

¹ Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
² Lambe Institute for Translational Medicine, and Curam, National University of Ireland Galway, Galway, Ireland. Electronic address: william.wyns@nuigalway.ie.

PMID: 31072511
DOI: 10.1016/j.jcin.2019.01.229

Abstract

Standardization of the most critical clinical and angiographic endpoints enables interpretability and comparability of different device trials. Since 2006, the Academic Research Consortium (ARC) group has taken the lead in gathering major stakeholders, such as the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), the Universal Definition of Myocardial Infarction (UDMI), and the Society for Cardiovascular Angiography and Interventions (SCAI), in order to agree on common definitions. As a result, consensus does exist regarding the essential definitions and reporting process for death, myocardial infarction, stroke, bleeding, or repeat revascularization.

Keywords: clinical trials; core laboratories; endpoints; standardization.

Publication types

Comment

MeSH terms

Aortic Valve Stenosis / surgery*
Consensus
Heart Valve Prosthesis Implantation*
Humans
Myocardial Infarction*
Treatment Outcome