The European Medicines Agency is seeking public input on a Concept Paper outlining the framework for a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials.
In drug development, non-inferiority comparisons to active comparators play a pivotal role, particularly in phase 3 trials aimed at supporting marketing authorization applications. Addressing specific considerations unique to non-inferiority and therapeutic equivalence comparisons, distinct from those encountered in superiority trials, is crucial.
Currently, the EMA has two guidance documents on this subject: the Guideline on the Choice of Non-Inferiority Margin (2005) and the Points to consider on Switching between Superiority and Non-Inferiority (2000). However, with ongoing methodological advancements, there’s a proposal to merge and consolidate both documents into a comprehensive new guideline, reflecting these developments.
Stakeholders are invited to submit their comments by May 31, 2024, utilizing the EU survey form. Consider your opportunity to become part of the discussion in phase 3 trials and marking authorization applications.
You can read the draft document here.
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