• Clinical Trials E7 - E11

    Code Document Title Previously coded
    • E9Statistical Principles for Clinical Trials

      Finalised Guideline:
      February 1998

      E9
      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

      EU:

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

      MHLW:

      Adopted November 1998, PMBS/ELD Notification No. 1047

      FDA:

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