Non-inferiority cancer clinical trials: scope and purposes underlying their design

Definition:  Non-inferiority trials are a type of clinical trial performed to see if a new drug or treatment is "not inferior" to a current treatment (an active treatment). The active treatment is often considered the "standard of care" or the "gold standard." Another way to describe these trials is that they are used to determine if a new treatment is "at least as good as," or "not unacceptably worse than," the active treatment.

Abstract

Conclusion Cancer NIFCT harbor serious methodological and ethical issues. Many use large NIFm and nearly one-fifth did not state a clear purpose for selecting a non-inferiority design.