The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new drugs in clinical trials. The proposal aims to incorporate the International Council for Harmonisation’s (ICH) guideline on estimand and sensitivity analyses in clinical trials and consolidate existing guidance on inferiority trials.
According to a new concept paper, the guideline aims to “provide clarity and advice with respect to the application of the estimand framework for non-inferiority comparisons” and “improve planning of confirmatory trials that include non-inferiority comparisons and therapeutic equivalence comparisons by sponsors and lead to improved scientific advice and regulatory assessment.”…
