Skip to Main Content

Which study type is that? A guide to study types

Study and experiment types for Health Sciences and Medicine

Non-inferiority - Equivalence - Superiority

non-inferiority equivalence and superiority trial

Non-inferiority


A non-inferiority trial is a clinical study that aims to show a new treatment isn't much worse than an existing one. It uses a pre-set margin to define the maximum acceptable difference in outcomes, like recovery rates. Patients are randomly assigned to either the new or standard treatment, and their outcomes are compared. If the difference falls within the margin, the new treatment is considered "not inferior". These trials are useful when the new treatment might have other benefits, like fewer side effects or lower cost, without losing much effectiveness.

Equivalence trial


An equivalence trial is a clinical study to see if a new treatment is as effective as an existing one. It aims to show that the new treatment is neither much better nor worse than the standard treatment within an acceptable range, called the equivalence margin. Participants are randomly assigned to either the new or standard treatment and the outcomes, such as recovery rates or symptom relief  are measured. If the differences fall within the margin the new treatment is considered equivalent. These trials are useful for introducing new versions or delivery methods of existing medications and ensuring they work just as well.

Superiority trial


A superiority trial is a clinical study to see if a new treatment is more effective than an existing one or a placebo. It starts with the idea that the new treatment will work better. Participants are randomly assigned to either the new treatment or a control group to ensure fair comparison. Researchers measure outcomes like symptom improvement or recovery rates and analyse the differences using statistical methods. If the new treatment shows significantly better results it is considered superior. If not, it's seen as no better than the control. These trials are important for proving that new treatments offer better outcomes.

Further reading and resources

  • Dunn, D. T., Copas, A. J., & Brocklehurst, P. (2018). Superiority and non-inferiority: two sides of the same coin?. Trials, 19, 1-5. Full Text
     
  • Kishore, K., & Mahajan, R. (2020). Understanding Superiority, Noninferiority, and Equivalence for Clinical Trials. Indian dermatology online journal, 11(6), 890–894. Full Text
     
  • Rothmann, M.D., Wiens, B.L., & Chan, I.S.F. (2011). Design and Analysis of Non-Inferiority Trials (1st ed.). Catalogue Link
     
  • Tweed, C. D., Quartagno, M., Clements, M. N., Turner, R. M., Nunn, A. J., Dunn, D. T., ... & Copas, A. J. (2024). Exploring different objectives in non-inferiority trials. bmj, 385. Full Text
     
  • Wayant, C., Ross, A., & Vassar, M. (2020). Methodological quality of oncology noninferiority clinical trials. Critical Reviews in Oncology/Hematology, 149, 102938. Full Text
     
  • Watanabe, A., Chang, S. C., Kim, M. J., Chu, D. W. S., Ohashi, Y., & MARVEL Study Group. (2010). Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: a double-blind, randomized, noninferiority clinical trial. Clinical Infectious Diseases, 51(10), 1167-1175. Full Text

 

 


Library Instagram

Library Blogs

Library Contacts