• Clinical Trials E7 - E11

    Code Document Title Previously coded
    • Finalised Guideline:
      July 2000

      Description:

      The harmonised tripartite Guideline was finalised under Step 4 in July 2000. This document addresses the choice of control groups in clinical trials considering the ethical and inferential properties and limitations of different kinds of control groups. It points out the assay sensitivity problem in active control equivalence / non-inferiority trials that limits the usefulness of trial design in many circumstances.

      Implementation:

      Step 5

      EU:

      Adopted by CPMP, July 2000, issued as CPMP/ICH/364/96

      MHLW:

      Adopted 27 February 2001, PMSB/ELD Notification No. 136

      FDA:

      Published in the Federal Register, 14 May 2001, Vol. 66, No. 93, p. 24390-91