FDA Finalizes Non-inferiority Trial Guidelines, Withdraws Antimicrobial Recommendations

Sponsors should continue to use a drug with a well-defined effect as their active control in non-inferiority studies, the FDA said.

Finalizing guidance on NI trials, the FDA reiterates its recommendations for study designs, statistical approaches and synthesis methods from a draft version issued in 2010. The final 56-page guidance will replace a guideline on NI trials for antimicrobials, which was withdrawn, the FDA said.

The new document, which remains virtually unchanged from the draft, now advises sponsors to not use the recommended trial designs to evaluate the safety of a new drug.