Superiority trial

A superiority trial design aims to show that one treatment is clinically better than the other by demonstrating superiority of the test agent over placebo or an active treatment.

Regulatory agencies require a superiority trial when there is no licensed comparator available or the treatment effect of any licensed treatment is unknown or is considered questionable (e.g. acute self-limiting infections). For adjunctive treatments, the superiority design demonstrates a clinical effect of the adjunctive treatment vs. standard of care.

Superiority, Equivalence, and Non-Inferiority Trials (Bulletin of the NYU Hospital for Joint Diseases, 2008) 

Statistical Considerations for Randomized Controlled Trials [RCTs] – Understanding Superiority, Equivalence and Non-inferiority Designs (The Journal of the Association of Physicians of India, 2017).

Non-inferiority versus superiority drug claims: the (not so) subtle distinction (Trials, 2017)

Clinical Research Methodology 3: Randomized Controlled Trials (Anesthesia & Analgesia, 2015) 

White Paper: Recommendations on the Conduct of Superiority and Organism-Specific Clinical Trials of Antibacterial Agents for the Treatment of Infections Caused by Drug-Resistant Bacterial Pathogens (Clinical Infectious Diseases, 2012)

Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, Rev. 3 (EMA, 2018)

Points to consider on switching between superiority and non-inferiority (EMA, 2008)

Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases – Guidance for industry (FDA, 2017)