Abstract
The intent of a non-inferiority trial and an equivalence trial is to determine whether an experimental treatment is similar to a control. This is in contrast to a traditional parallel group trial where the objective is to determine whether an experimental treatment differs from a control.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Blackwelder WC. Proving the null hypothesis in clinical trials. Control Clin Trials. 1982;3(4):345–53.
Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15(6):657–80.
Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313:36–9.
Rauch SD, Halpin CF, Antonelli PJ, et al. Oral versus intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. JAMA. 2011;305(20):2071–9.
Fleshman J, Branda M, Sargent DJ, et al. Effect of laparoscopic-assisted resection versus open resection of stage II or III rectal cancer on pathologic outcomes: the ACOSOG Z6051 randomized clinical trial. JAMA. 2015;314(13):1346–55.
Mulla SM, Scott IA, Jackevicius CA, et al. How to use a noninferiority trial. JAMA. 2012;308(24):2605–11.
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Nov 2016. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer International Publishing AG
About this chapter
Cite this chapter
Reda, D.J. (2017). Non-inferiority and Equivalence Trials. In: Itani, K., Reda, D. (eds) Clinical Trials Design in Operative and Non Operative Invasive Procedures. Springer, Cham. https://doi.org/10.1007/978-3-319-53877-8_7
Download citation
DOI: https://doi.org/10.1007/978-3-319-53877-8_7
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-53876-1
Online ISBN: 978-3-319-53877-8
eBook Packages: MedicineMedicine (R0)