Clinical Gastroenterology and Hepatology
Volume 7, Issue 11 , Pages 1156-1163, November 2009

Evidence for Endoscopic Ulcers as Meaningful Surrogate Endpoint for Clinically Significant Upper Gastrointestinal Harm

  • Andrew Moore

      Affiliations

    • Pain Research and Nuffield Department of Anaesthetics, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom
    • Corresponding Author InformationReprint requests Address requests for reprints to: Dr Andrew Moore, Pain Research and Nuffield Department of Anaesthetics, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom, OX3 9DU. fax: (44) 1865 234539
    • ,
  • Ingvar Bjarnason

      Affiliations

    • Department of Medicine, King's College Hospital, Denmark Hill, London, United Kingdom
    • ,
  • Byron Cryer

      Affiliations

    • Medical Service, Department of Veterans Affairs Medical Center, Dallas, Texas
    • ,
  • Luis Garcia–Rodriguez

      Affiliations

    • Spanish Centre for Pharmacoepidemiological Research (CEIFE), Madrid, Spain
    • ,
  • Larry Goldkind

      Affiliations

    • Uniformed Services University of Health Sciences, School of Medicine, Bethesda, Maryland
    • ,
  • Angel Lanas

      Affiliations

    • Department of Gastroenterology, University Hospital, Institute of Health Sciences of Aragon, Zaragoza, Spain
    • ,
  • Lee Simon

      Affiliations

    • Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts

published online 13 April 2009.

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    •  Conflicts of interest The authors disclose the following: All the authors have received research grants, consulting, or lecture fees from pharmaceutical companies, charities, and government sources at various times. The authors were involved in discussions concerning a review, supported by Pfizer Inc, for the creation of a white paper for presentation to regulatory authorities. The decision to write this paper was the decision of the authors. Pfizer and its agents had no role in the interpretation of data or writing of the paper, or in the decision to publish. The authors had the absolute right to publish the results of their research regardless of any conclusions reached. No payments were received for preparing this manuscript.

    PII: S1542-3565(09)00316-4

    doi:10.1016/j.cgh.2009.03.032

    Refers to article:

    • Endoscopic Ulcers Are Neither Meaningful Nor Validated as a Surrogate for Clinically Significant Upper Gastrointestinal Harm , 26 June 2009

      David Y. Graham
      Clinical Gastroenterology and Hepatology November 2009 (Vol. 7, Issue 11, Pages 1147-1150)

    Clinical Gastroenterology and Hepatology
    Volume 7, Issue 11 , Pages 1156-1163, November 2009