Analysis of Information Submitted by Clinical Trial Sponsors regarding the Safety of Investigational Drugs

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  • TAKAYANAGI Risa
    Departments of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo
  • NAKAMURA Yuko
    Departments of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo
  • NAKAJIMA Yuko
    Departments of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo
  • SHIMIZU Akemi
    Departments of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo
  • NAKAMURA Hitoshi
    Departments of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo
  • YAMADA Yasuhiko
    Departments of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo
  • SUZUKI Hiroshi
    Departments of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo
  • ARAKAWA Yoshihiro
    Clinical Research Center, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo
  • OMATA Masao
    Clinical Research Center, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo
  • IGA Tatsuji
    Departments of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo

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Description

During performance of clinical trials in medical institutions, information regarding the safety of investigational drugs is submitted by trial sponsors according to guidelines for good clinical practice. In the present study, reports of clinical trials conducted at the University of Tokyo Hospital were examined, focusing on the safety information provided to the Institutional Review Board (IRB). Two hundred two reports (52 protocols) of safety information were submitted to the IRB by clinical trial sponsors between April 2000 and March 2001, of which 185 contained a total of 3021 cases of adverse events. Of those, 194 reports were judged by clinical investigators/physicians not to be associated with any significant problems and the trials were continued. For 157 of those 194 reports, it was considered unnecessary to inform the test subjects of the report contents, including the adverse events. The decision of whether or not the test subjects should be informed of such contents tended to depend on the causal relationship between the adverse events and drug intake, as well as the predictability of the adverse events. For 8 of those 194 reports, the IRB recommended that the clinical investigators/ physicians provide information to the test subjects and/or submit detailed information on the status of these subjects to the IRB. From these results, we suggest that establishment of a system to unify and evaluate drug safety information is necessary to provide safe and efficient clinical trials.<br>

Journal

  • YAKUGAKU ZASSHI

    YAKUGAKU ZASSHI 124 (4), 225-229, 2004-04-01

    The Pharmaceutical Society of Japan

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