Non-inferiority trials have become an essential instrument in clinical research, particularly when the goal is to demonstrate that an experimental treatment is not unacceptably worse than an ...

The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an ...

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 ...

Non-inferiority study designs “may be appropriate when there is adequate evidence of a defined effect size for the control treatment so that the proposed NI margin can be supported”, the draft ...