Non-inferiority and Equivalence Trials 2012

The main CONSORT Statement provides recommendations for reporting randomized controlled trials, which aim to determine whether one intervention is superior to another. Equivalence trials, on the other hand, aim to determine whether one intervention is therapeutically similar to another. Also non-inferiority trials aim to determine whether one treatment is no worse than another.

For example, a new antenatal care model with fewer clinic visits and lower costs might be compared with a standard model in terms of maternal and neonatal outcomes.

Noninferiority and equivalence trials have methodological features that differ from superiority trials and present particular difficulties in design, conduct, analysis, and interpretation. Although the rationale for such trials occurs frequently, those designed and described specifically as noninferiority or equivalence trials appear less commonly in medical literature. The quality of reporting of those that are published is often inadequate.

Piaggio and colleagues adapted the CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.


Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012; 308(24): 2594-2604. doi:10.1001/jama.2012.87802.

Page last edited: 19 February 2013