Contents
What is a good noninferiority margin?
A preserved fraction of 50% has become common practice in noninferiority trials (e.g. cardiovascular, irreversible morbidity, and mortality outcomes), but higher (i.e. stricter) fractions have been used (e.g. 90% preserved fraction in antibiotics) 2, 3, 12, 14, 17, 18.
What is non-inferiority clinical trial?
A study that tests whether a new treatment is not worse than an active treatment it is being compared to. Non-inferiority trials are sometimes done when a placebo (an inactive treatment) cannot be used.
What does non inferior mean?
Abstract. As clinicians, we are frequently faced with papers stating that something is ‘non-inferior’ to something else. By definition, a non-inferiority trial aims to demonstrate that the test product is not worse than the comparator by more than a small pre-specified amount.
What is a per protocol population?
Per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violations.
How to calculate the sample size of a non inferiority trial?
In this paper, the steps for condu … Practical guide to sample size calculations: non-inferiority and equivalence trials Pharm Stat. Jan-Feb 2016;15(1):80-9.doi: 10.1002/pst.1716. Epub 2015 Nov 25.
Which is the best approach for sample size estimation?
We argue that the decision theory approach of sample size estimation is most suitable for sample size calculation of non-inferiority trials. Citation: Bouman AC, ten Cate-Hoek AJ, Ramaekers BLT, Joore MA (2015) Sample Size Estimation for Non-Inferiority Trials: Frequentist Approach versus Decision Theory Approach.
How to calculate the non inferiority margin in nissc?
Non-inferiority margin in terms of hazard ratio: The largest difference in hazard ratio that is clinically acceptable S.C. Chow, H. Wang, and J. Shao, Sample Size Calculations in Clinical Research, Second Edition. CRC Press, 2007, p. 174-179
Why are non inferiority margins used in clinical trials?
An accepted difference in main therapeutic effect, the non-inferiority margin, is introduced in order to enable testing for statistical significance. Although guidelines exist on the choice of the non-inferiority margin, the choice of the margin remains arbitrary. [ 3, 7, 8]