• E9 Statistical Principles for Clinical Trials

    Code Document Title Previously coded
    • Finalised Guideline:
      February 1998

      Description :

      The harmonised tripartite Guideline was finalised under Step 4 in February 1998. This biostatistical Guideline describes essential considerations on the design and analysis of clinical trials, especially the "confirmatory" (hypothesis-testing) trials that are the basis for demonstrating effectiveness.

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CPMP, March 1998, issued as CPMP/ICH/363/96

      :

      MHLW/PMDA, Japan Adopted November 1998, PMBS/ELD Notification No. 1047

      :

      FDA, US Published in the Federal Register, 16 September 1998, Vol. 63, No. 179, p. 49583

      :

      Health Canada, Canada Implemented 10 February 2003, File #: 03-102451-780

      :

      Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website