DATA POINT 9 Superiority and Non Inferiority in Clinical Trials A HICS Initiative
Non‑Inferiority and Superiority in Clinical Trials: Concepts, Rationale, and Statistical Approaches Clinical trials are designed to evaluate whether a new intervention provides meaningful benefit compared with an existing standard of care or placebo. Traditionally, the gold standard has been the superiority trial , which aims to demonstrate that a new treatment is better than its comparator. However, as medicine has evolved—particularly in areas where effective treatments already exist— non‑inferiority trials have become increasingly impor...