Simplifying and Interpreting the Facts of Non-Inferiority Trials

Simplifying and interpreting the FACTS of noninferiority trials: A stepwise approach

When assessing the clinical relevance of a noninferiority trial, it is first prudent to examine the historical efficacy of the standard of care relative to a placebo or active comparator in clinical trials and meta-analyses.

This will assist in putting in context the comparative efficacy of the therapies as well as the appropriateness of the interventions. While two therapies may be considered noninferior to each other, it is possible that there are additional factors, such as safety considerations, cost, and convenience, that favor one therapy over another in clinical practice.

Additionally, analyzing the demographics of the patients investigated will aid clinicians in determining if and to what extent the results can be extrapolated to the patients they serve.

In assessing the clinical relevance of noninferiority trials, clinicians may inquire as to whether the number needed to treat (NNT) was or can be calculated. If only noninferiority was established in a trial, the difference between the two treatments should be marginal, and the NNT would not add clinically valuable knowledge since it can only be concluded that the therapies are no worse than each other.

However, if a noninferiority trial also meets the criteria for demonstration of superiority, then calculating the NNT might provide additional information to assess the risk–benefit profile of the treatment of interest.

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