What Is Non Inferiority. Office of Communications Division of Drug Information. Guidance for Industry Additional copies are available from.
In the current example a difference of one month say might be the maximum that can be considered equal so. In a non-inferiority trial by contrast the aim is to show that a new product is not unacceptably worse than an older one. The 10 here is the non-inferiority margin.
In a noninferiority trial one is interested in showing that the new treatment is not inferior to the standard treatment.
Superiority trials are always used when comparisons are made to placebo or vehicle treatments. In an equivalence trial the desired conclusion is that two products are the same or not unacceptably different from each other. Office of Communications Division of Drug Information. Only when the advantages of the trial treatment clearly overcome the amount of worsening which is implicit.
