[Documents for clinical trials of new drugs: results of their reviews prior to submissions to IRB].

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  • Additional Information
    • Source:
      Publisher: Nihon Yakugakkai Country of Publication: Japan NLM ID: 0413613 Publication Model: Print Cited Medium: Print ISSN: 0031-6903 (Print) Linking ISSN: 00316903 NLM ISO Abbreviation: Yakugaku Zasshi Subsets: MEDLINE
    • Publication Information:
      Original Publication: Tokyo : Nihon Yakugakkai
    • Subject Terms:
      Clinical Trials Data Monitoring Committees* ; Clinical Trials as Topic* ; Ethics Committees, Research*; Humans
    • Abstract:
      A prior review process was introduced in the Institutional Review Board (IRB) of the University of Tokyo Hospital to facilitate the evaluation of clinical trial plans for new drugs. This study summarizes the results of prior reviews of 73 protocols that were submitted to the IRB during 1999-2000. A total of 955 items were taken up for discussion at the prior review. Among them, 325 (34.0%) were related to the profile/description of investigational drugs themselves, and 252 (26.4%) were related to the trial plan. Major requests related to investigational drugs and given to applicants after the prior review were on adverse reactions, pharmacodynamics, and pharmacokinetics. Items related to patient selection criteria and usage of concomitant drugs were major requests related to the protocol. In some cases, protocols were amended by applications in accordance with the requests. The study shows that the review of new drug clinical trial plans prior to the evaluation by the IRB and examination from a pharmaceutical viewpoint are meaningful and worthwhile.
    • Publication Date:
      Date Created: 20030423 Date Completed: 20030618 Latest Revision: 20190724
    • Publication Date:
      20240829
    • Accession Number:
      10.1248/yakushi.123.249
    • Accession Number:
      12704864