Trials to assess equivalence: the importance of rigorous methods
- PMID: 8664772
- PMCID: PMC2351444
- DOI: 10.1136/bmj.313.7048.36
Trials to assess equivalence: the importance of rigorous methods
Erratum in
- BMJ 1996 Aug 31;313(7056):550
Abstract
The aim of an equivalence trial is to show the therapeutic equivalence of two treatments, usually a new drug under development and an existing drug for the same disease used as a standard active comparator. Unfortunately the principles that govern the design, conduct, and analysis of equivalence trials are not as well understood as they should be. Consequently such trials often include too few patients or have intrinsic design biases which tend towards the conclusion of no difference. In addition the application of hypothesis testing in analysing and interpreting data from such trials sometimes compounds the drawing of inappropriate conclusions, and the inclusion and exclusion of patients from analysis may be poorly managed. The design of equivalence trials should mirror that of earlier successful trials of the active comparator as closely as possible. Patient losses and other deviations from the protocol should be minimised; analysis strategies to deal with unavoidable problems should not centre on an "intention to treat" analysis but should seek to show the similarity of results from a range of approaches. Analysis should be based on confidence intervals, and this also carries implications for the estimation of the required numbers of patients at the design stage.
Comment in
-
Placebo mania.BMJ. 1996 Jul 6;313(7048):3-4. doi: 10.1136/bmj.313.7048.3a. BMJ. 1996. PMID: 8664770 Free PMC article. No abstract available.
Similar articles
-
Practical issues in equivalence trials.Stat Med. 1998 Aug 15-30;17(15-16):1691-701. doi: 10.1002/(sici)1097-0258(19980815/30)17:15/16<1691::aid-sim971>3.0.co;2-j. Stat Med. 1998. PMID: 9749440
-
[Methodology for superiority versus equivalence and non-inferior clinical studies. A practical review].Rev Med Inst Mex Seguro Soc. 2016 May-Jun;54(3):344-53. Rev Med Inst Mex Seguro Soc. 2016. PMID: 27100981 Review. Spanish.
-
Clinical and statistical issues in therapeutic equivalence trials.Eur J Clin Pharmacol. 1993;45(1):1-7. doi: 10.1007/BF00315342. Eur J Clin Pharmacol. 1993. PMID: 8405023
-
[Methodological and statistical aspects of equivalence and non inferiority trials].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.
-
Equivalence testing with dental clinical trials.J Dent Res. 2001 Jun;80(6):1513-7. doi: 10.1177/00220345010800060701. J Dent Res. 2001. PMID: 11499504
Cited by
-
Internet-delivered interpersonal psychotherapy versus internet-delivered cognitive behavioral therapy for adults with depressive symptoms: randomized controlled noninferiority trial.J Med Internet Res. 2013 May 13;15(5):e82. doi: 10.2196/jmir.2307. J Med Internet Res. 2013. PMID: 23669884 Free PMC article. Clinical Trial.
-
Computed tomography of the cervical spine: comparison of image quality between a standard-dose and a low-dose protocol using filtered back-projection and iterative reconstruction.Skeletal Radiol. 2013 Jul;42(7):937-45. doi: 10.1007/s00256-013-1576-9. Epub 2013 Jan 29. Skeletal Radiol. 2013. PMID: 23359034 Clinical Trial.
-
Coadministration of orally inhaled zanamivir with inactivated trivalent influenza vaccine does not adversely affect the production of antihaemagglutinin antibodies in the serum of healthy volunteers.Clin Pharmacokinet. 1999;36 Suppl 1:51-8. doi: 10.2165/00003088-199936001-00006. Clin Pharmacokinet. 1999. PMID: 10429840 Clinical Trial.
-
Effects of Internet of Things-based power cycling and neuromuscular training on pain and walking ability in elderly patients with KOA: protocol for a randomized controlled trial.Trials. 2022 Dec 13;23(1):1009. doi: 10.1186/s13063-022-06946-x. Trials. 2022. PMID: 36514174 Free PMC article.
-
Treatment of acute pyelonephritis in children: conclusions should have been more cautious.BMJ. 2004 Apr 17;328(7445):957; author reply 957. doi: 10.1136/bmj.328.7445.957. BMJ. 2004. PMID: 15087362 Free PMC article. No abstract available.
References
MeSH terms
LinkOut - more resources
Full Text Sources
Medical