FDA guidance to industry's non inferiority trials.

Despite a global dislike by many regulatory authorities, many clinical studies adopt a non inferiority design for dossier support. In order to avoid loopholes and traps, US FDA finalized its new guidance to pharmaceutical and biotech sponsors looking for more advice on wether non-inferiority studies can demonstrate an investigational treatment efficiency. How can this kind of study design provide companies and investigators with interpretable results, how can one chose the non-inferiority margin and how to test the non-inferiority hypothesis.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf

Please notice that non inferiority study design is still to be accompanied by another parameter "to pay for" (can we accept a decrease in hospitalization time in exchange for non inferiority against product X ?)