Journal article
Monitoring the ACTIVE-W trial: Some issues in monitoring a noninferiority trial
Abstract
Noninferiority comparisons of new to current therapies and the use of composite outcomes represent significant advances in the design of clinical trials. They increasingly characterize trials of new cardiovascular agents, posing new challenges to Data Safety Monitoring Boards (DSMB) and principal investigators. The ACTIVE-W study was a noninferiority comparison of the combination of clopidogrel and acetylsalicylic acid versus oral anticoagulant …
Authors
Cairns JA; Wittes J; Wyse DG; Pogue J; Gent M; Hirsh J; Marler J; Pritchett ELC
Journal
American Heart Journal, Vol. 155, No. 1, pp. 33–41
Publisher
Elsevier
Publication Date
1 2008
DOI
10.1016/j.ahj.2007.09.011
ISSN
0002-8703
Associated Experts
Fields of Research (FoR)
Medical Subject Headings (MeSH)
Administration, OralAnticoagulantsAspirinAtrial FibrillationBiphenyl CompoundsClinical Trials Data Monitoring CommitteesClopidogrelDecision MakingFemaleHumansIrbesartanMalePrognosisRandomized Controlled Trials as TopicResearch DesignRisk AssessmentSensitivity and SpecificitySurvival AnalysisTetrazolesTiclopidineTreatment Outcome