Assessment of the End Point Adjudication Process on the Results of the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Author(s) -
Mary Farrant,
J. Donald Easton,
Eric E. Adelman,
Brett Cucchiara,
William G. Barsan,
Holly Tillman,
Jordan Elm,
Anthony Kim,
Anne S. Lindblad,
Amy Yu,
Wenle Zhao,
Keith Pauls,
Kyle Walsh,
Joan MartíFàbregas,
Richard A. Bernstein,
S. Claiborne Johnston
Publication year - 2019
Publication title -
jama network open
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.278
H-Index - 39
ISSN - 2574-3805
DOI - 10.1001/jamanetworkopen.2019.10769
Subject(s) - medicine , clopidogrel , clinical endpoint , aspirin , stroke (engine) , clinical trial , randomized controlled trial , randomization , placebo , emergency medicine , pathology , mechanical engineering , alternative medicine , engineering
Key Points Question Is there an advantage to centrally adjudicating clinical trial end points compared with relying on investigator-assessed end points? Findings In this secondary analysis of an international randomized clinical trial of 4881 patients who received clopidogrel bisulphate plus aspirin vs placebo plus aspirin, independent end point adjudication did not substantially change estimates of the primary treatment associations compared with investigator-assessed end points. Meaning Independent end point adjudication may have no clinically meaningful improvement on estimates of treatment associations in studies of transient ischemic attack and minor stroke when masking is well controlled and training is provided.
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