Non-inferiority versus superiority drug claims: the (not so) subtle distinction-Reference-Cited by-同舟云学术

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

Published:2017-06-15 Issue:1 Volume:18 Page:
ISSN:1745-6215
Container-title:Trials
language:en
Short-container-title:Trials

Author:

Ganju Jitendra,Rom Dror

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1186/s13063-017-2024-2.pdf

Reference17 articles.

1. Jones LV, Tukey JW. A sensible formulation of the significance test. Psychol Methods. 2000;5:411–4.

2. FDA Guidance for Industry. Non-inferiority clinical trials to establish effectiveness. 2016. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm202140.pdf . Accessed 12 June 2017.

3. The European Agency for Evaluation of Medical Products. Points to consider on switching between superiority and non-inferiority. 2000. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf . Accessed 12 June 2017.

4. Fleming TR. Current issues in non-inferiority trials. Stat Med. 2008;27:317–32.

5. D’Agostino Sr RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues—the encounters of academic consultants in statistics. Stat Med. 2003;22:169–86.

Cited by 14 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Enhancing prone positioning and skin damage prevention education: A randomized controlled non-inferiority trial comparing a digital education hub (PRONEtect) and a traditional lecture on final-year nursing participants’ confidence and knowledge;Journal of Tissue Viability;2024-05

2. Prospective randomized multicenter noninferiority clinical trial evaluating the use of TFN-advancedTM proximal femoral nailing system (TFNA) for the treatment of proximal femur fracture in a Chinese population;European Journal of Trauma and Emergency Surgery;2023-02-13

3. Treatment of type 2 diabetes mellitus using the traditional Chinese medicine Jinlida as an add-on medication: A systematic review and meta-analysis of randomized controlled trials;Frontiers in Endocrinology;2022-10-17

4. Assessing the Impacts of Cluster Effects and Covariate Imbalance in Cluster Randomized Equivalence Trials;Statistics in Biopharmaceutical Research;2022-06-06

5. Non‐inferiority and clinical superiority of glucagon‐like peptide‐1 receptor agonists and sodium‐glucose co‐transporter‐2 inhibitors: Systematic analysis of cardiorenal outcome trials in type 2 diabetes;Diabetes, Obesity and Metabolism;2022-05-29