Sample Size Calculation Guide - Part 6: How to calculate the sample size for a non-inferiority or an equivalence clinical trial

  • Ahmed Negida ORCID Mail Faculty of Medicine, Zagazig University, Zagazig, El-Sharkia, Egypt

Abstract

In the previous educational articles, we explained how to calculate the sample size for a rate or a single proportion, for an independent cohort study, for an independent case-control study, for a diagnostic test accuracy study, and for a superiority clinical trial. In this article, we will explain how to calculate the sample size for a non-inferiority or equivalence clinical trial.

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References

1. Fahim NK, Negida A. Sample size calculation guide - part 1: how to calculate the sample size based on the prevalence rate. Adv J Emerg Med. 2018;2(4):e50.
2. Fahim NK, Negida A. Sample size calculation guide - part 2: how to calculate the sample size for an independent cohort study. Adv J Emerg Med. 2019;3(1);e12.
3. Fahim NK, Negida A, Fahim AK. Sample size calculation guide - part 3: how to calculate the sample size for an independent case-control study. Adv J Emerg Med. 2019;3(2):e20.
4. Negida A, Fahim NK, Negida Y. Sample size calculation guide - part 4: how to calculate the sample size for a diagnostic test accuracy study based on sensitivity, specificity, and the area under the roc curve. Adv J Emerg Med. 2019;3(3):e33.
5. Negida A, Fahim NK, Negida Y, Ahmed H. Sample Size Calculation Guide - Part 5: How to calculate the sample size for a superiority clinical trial. Adv J Emerg Med. 2019;3(4):e49.
6. Bouman CA, van Herwaarden N, van den Hoogen FH, Fransen J, van Vollenhoven RF, Bijlsma JW, et al. Long-term outcomes after disease activity-guided dose reduction of TNF inhibition in rheumatoid arthritis: 3-year data of the DRESS study-a randomised controlled pragmatic non-inferiority strategy trial. Ann Rheum Dis. 2017;76(10):1716-22.
Published
2019-11-27
How to Cite
1.
Negida A. Sample Size Calculation Guide - Part 6: How to calculate the sample size for a non-inferiority or an equivalence clinical trial. Adv J Emerg Med. 4(1):e15.
Section
Educational Notes in Research Methodology and Medical Statistics