Non-inferiority and equivalence comparisons in clinical trials - Scientific guideline
HumanClinical trialsScientific guidelines
Non-inferiority comparisons to active comparators are frequently used in drug development and specifically, in phase 3 trials, intended to provide pivotal evidence for marketing authorisation applications. Specific issues related to non-inferiority and therapeutic equivalence comparisons require considerations different from those encountered in superiority trials. Two EMA guidance documents on this issue are currently available, the Guideline on the Choice of Non-Inferiority Margin, adopted by the CHMP in 2005, and the Points to consider on Switching between Superiority and Non-Inferiority, adopted by the CHMP in 2000. Following methodological developments, as outlined in the subsequent sections, it is suggested merging and consolidating both documents in a new guideline to include these developments.