American Heart Journal
Volume 155, Issue 1 , Pages 33-41 , January 2008

Monitoring the ACTIVE-W trial: Some issues in monitoring a noninferiority trial

  • John A. Cairns, MD

      Affiliations

    • University of British Columbia, Vancouver, British Columbia, Canada
    • Corresponding Author InformationReprint requests: John Cairns, MD, GLD Health Care Centre, 2775 Laurel St, Rm 9113, Vancouver, British Columbia, Canada V5Z1M9.
    • ,
  • Janet Wittes, PhD

      Affiliations

    • Statistics Collaborative, Inc., Washington, DC
    • ,
  • D. George Wyse, MD, PhD

      Affiliations

    • Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada
    • ,
  • Janet Pogue, MSc

      Affiliations

    • McMaster University, Hamilton, Ontario, Canada
    • ,
  • Michael Gent, DSc

      Affiliations

    • McMaster University, Hamilton, Ontario, Canada
    • ,
  • Jack Hirsh, MD

      Affiliations

    • McMaster University, Hamilton, Ontario, Canada
    • ,
  • John Marler, MD

      Affiliations

    • National Institute of Neurological Disorders and Stroke, Bethesda, MD
    • ,
  • Edward L.C. Pritchett, MD

      Affiliations

    • Duke University, Durham, NC

Received 29 May 2007 ,Accepted 4 September 2007.

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 Funding of ACTIVE-W (Clinical Trials.gov, number NCT00243178) by Sanofi-Aventis and Bristol-Myers Squibb. No funding requested or provided for the present publication.

 Conflicts of interest: all coauthors were members of the ACTIVE-W DSMB and received honoraria for their participation. Cairns, Wittes, Pogue, Gent, Hirsh, Pritchett—none additional; Wyse—Scientific Advisory Board Sanofi Aventis; Hirsh—consulted on clopidogrel, chaired advisory boards for Bristol-Myers Squibb.

PII: S0002-8703(07)00775-2

doi: 10.1016/j.ahj.2007.09.011

American Heart Journal
Volume 155, Issue 1 , Pages 33-41 , January 2008

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