Pros and Cons of Noninferiority Trials

Author:

Ofori Sandra,Tornberg Sara V.ORCID,Kilpeläinen Tuomas P.,Tikkinen Kari A.O.,Guyatt Gordon H.,Witte Lambertus P.W.

Funder

Sigrid Juséliuksen Säätiö

Helsingin ja Uudenmaan Sairaanhoitopiiri

Suomen Lääketieteen Säätiö

Publisher

Elsevier BV

Subject

Urology

Reference10 articles.

1. US Food and Drug Administration. Non-inferiority clinical trials to establish effectiveness: guidance for industry. Silver Spring, MD: Center for Drug Evaluation and Research, FDA; 2016. https://www.fda.gov/media/78504/download.

2. Methods of defining the non-inferiority margin in randomized, double-blind controlled trials: a systematic review;Althunian;Trials,2017

3. Use of mortality as an endpoint in noninferiority trials may lead to ethically problematic conclusions;Hersh;J Gen Intern Med,2019

4. Challenges in the design and interpretation of noninferiority trials: insights from recent stent trials;Macaya;J Am Coll Cardiol,2017

5. How to use a noninferiority trial: users’ guides to the medical literature;Mulla;JAMA,2012

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