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In this talk given during the Controversies in Rectal Cancer Conference 2017 , which was held in London (UK) in October 2017, Dr. Delaney explains the design of non-inferiority trials, their benefits and their drawbacks, as well as the common pitfalls in interpretation through examples, such as the laparoscopic trials.
Unlike superiority trials , which try to prove a better or worse outcome between two groups with an intervention, non-inferiority trials try to establish whether the new intervention is not worse than the control, which involves several statistical considerations.
Several non-inferiority trials have been designed to assess the open vs laparoscopic approach to rectal cancer, including the ACOSOG Z6051 , ALACART , COLOR II , and Corean trials, along with the laparoscopic vs robotic trial, the ROLARR trial .