Design and Analysis of Non-Inferiority Trials (2011)

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In recent years there has been frequent use of non-inferiority trial designs to establish the efficacy of an experimental agent. There has also been a proliferation of research articles on the design and analysis of non-inferiority studies. Points to Consider documents involving non-inferiority trials have been issued by the European Medicines Agency, and there is a draft guidance on non-inferiority trials that has been issued by the U.S. Food and Drug Administration. A typical non-inferiority trial randomizes subjects to an experimental regimen or to a standard of care, which is often referred to as an “active” control. A non-inferiority trial places a limit on the amount an experimental therapy is allowed to be inferior to a standard of care to still be considered worthwhile. This limit or non-inferiority margin should be selected so that a loss of efficacy of less than the margin relative to the standard of care implies that the experimental therapy has efficacy (relative to a placebo) and its efficacy is not unacceptably worse than the standard of care. A new treatment that offers a better safety profile or a more preferable method of administration compared to standard treatment may be beneficial even if somewhat less effective than standard treatment. There have been many non-inferiority clinical trials in various medical areas, including thrombolytic, oncology, cardiorenal, and anti-infective drugs, vaccines, and medical devices.

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