A sample size justification is a vital part of any trial design. However, estimating the number of participants required to give a meaningful result is not always straightforward. A number of components are required to facilitate a suitable sample size calculation. In this paper, the steps for conducting sample size calculations for non-inferiority and equivalence trials are summarised. Practical advice and examples are provided that illustrate how to carry out the calculations by hand and using the app SampSize.
Keywords: clinical trials; equivalence; non-inferiority; power; sample size.
Copyright © 2015 John Wiley & Sons, Ltd.
Flight L, Julious SA. Flight L, et al. Pharm Stat. 2016 Jan-Feb;15(1):68-74. doi: 10.1002/pst.1709. Epub 2015 Nov 20. Pharm Stat. 2016. PMID: 26585441
Flight L, Julious SA. Flight L, et al. Pharm Stat. 2016 Jan-Feb;15(1):75-9. doi: 10.1002/pst.1718. Epub 2015 Nov 20. Pharm Stat. 2016. PMID: 26585561
Elie C, De Rycke Y, Jais JP, Marion-Gallois R, Landais P. Elie C, et al. Rev Epidemiol Sante Publique. 2008 Aug;56(4):267-77. doi: 10.1016/j.respe.2008.05.027. Epub 2008 Aug 13. Rev Epidemiol Sante Publique. 2008. PMID: 18703296 Review. French.
Rosas-Peralta M, Santos-Martínez LE, Magaña-Serrano JA, Valencia-Sánchez JS, Garrido-Garduño M, Pérez-Rodríguez G. Rosas-Peralta M, et al. Rev Med Inst Mex Seguro Soc. 2016 May-Jun;54(3):344-53. Rev Med Inst Mex Seguro Soc. 2016. PMID: 27100981 Review. Spanish.
Christensen E. Christensen E. J Hepatol. 2007 May;46(5):947-54. doi: 10.1016/j.jhep.2007.02.015. Epub 2007 Mar 9. J Hepatol. 2007. PMID: 17412447 Review.
Gibbons S, Dexter F, Loftus RW, Wanta BT, Brindeiro CT, Hwang SM, Charnin JE. Gibbons S, et al. Cureus. 2024 Aug 1;16(8):e65963. doi: 10.7759/cureus.65963. eCollection 2024 Aug. Cureus. 2024. PMID: 39221375 Free PMC article.
Brown R, Cherian K, Jones K, Wickham R, Gomez R, Sahlem G. Brown R, et al. Cochrane Database Syst Rev. 2024 Aug 2;8(8):CD015040. doi: 10.1002/14651858.CD015040.pub2. Cochrane Database Syst Rev. 2024. PMID: 39092744 Review.
Hong B, Lee DK. Hong B, et al. Korean J Anesthesiol. 2024 Aug;77(4):423-431. doi: 10.4097/kja.23534. Epub 2024 Jul 30. Korean J Anesthesiol. 2024. PMID: 39081188 Free PMC article. Review.
Little RD, McKenzie J, Srinivasan A, Hilley P, Gilmore RB, Chee D, Sandhu M, Saitta D, Chow E, Thin L, Walker GJ, Moore GT, Lynch K, Andrews J, An YK, Bryant RV, Connor SJ, Garg M, Wright EK, Hold G, Segal JP, Boussioutas A, De Cruz P, Ward MG, Sparrow MP. Little RD, et al. BMJ Open. 2024 Jul 20;14(7):e081787. doi: 10.1136/bmjopen-2023-081787. BMJ Open. 2024. PMID: 39032928 Free PMC article.
Niimi N, Yang A, Sumie M, Hayes J, Maynes JT, Aoyama K. Niimi N, et al. J Anesth. 2024 Aug;38(4):421-424. doi: 10.1007/s00540-024-03355-z. Epub 2024 Jun 24. J Anesth. 2024. PMID: 38913235 No abstract available.