• 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 :

      Adopted by CPMP, March 1998, issued as CPMP/ICH/363/96

      MHLW/PMDA :

      Adopted November 1998, PMBS/ELD Notification No. 1047

      FDA :

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

      Health Canada :

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

      Swissmedic :

      Please refer to the press release on Swissmedic’s website for information on implementation