Steps in a typical equivalence data analysis

Steve Simon

2003-11-27

There are three approaches that are used to demonstrate equivalence, each with its advantages and disadvantages.

  1. Establish adequate power
  2. Report confidence intervals
  3. Perform two one-sided tests

Each of these approaches requires that you define a range of clinical indifference first.

Defining a range of clinical indifference

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Establishing adequate power

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Reporting confidence intervals

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Performing two one-sided tests

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Modifications for non-inferiority trials

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References

Barker LE, Luman ET, McCauley MM, Chu SY. Assessing Equivalence: An Alternative to the Use of Difference Tests for Measuring Disparities in Vaccination Coverage. Am. J. Epidemiol. 2002: 156(11); 1056-1061.

Blackwelder WC. “Proving the null hypothesis” in clinical trials. Controlled Clinical Trials 1982: 3(4); 345-53.

Djulbegovic B, Clarke M. Scientific and ethical issues in equivalence trials. Jama 2001: 285(9); 1206-8.

Dong BJ, Hauck WW, Gambertoglio JG, Gee L, White JR, Bubp JL, Greenspan FS. Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. Jama 1997: 277(15); 1205-13.

Hauschke D. Statistical Significance and Clinical Relevance: A Contradiction? Statistical Solutions. Available in html format

Hauschke D, Kieser M, Diletti E, Burke M. Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Stats in Medicine 1999: 18(1); 93-105.

International Federation of Pharmaceutical Manufacturers Associations. Choice of Control Group in Clinical Trials. Available in pdf format (This link is broken.)

Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. British Medical Journal 1996: 313(7048); 36-39. Available in html format

Roebruck P. Comparison of tests and sample size formulae for proving therapeutic equivalence based on the difference of binomial probabilities. Statistics in Medicine 1995: 141583-94.

Senn S, Of Drafts and Gales: Speaker’s Forum Monthly Article. Statistical Solutions. Available in html format (This link is broken.)

Tubert-Bitter P, Manfredi R, Lellouch J, Begaud B. Sample size calculations for risk equivalence testing in pharmacoepidemiology. Journal of Clinical Epidemiology 2000: 53(12); 1268-1274.

Ware J, Antman E. Equivalence trials. NEJM 1997: 337(16); 1159-61. Available in html format (This link is broken.)

You can find an earlier version of this page on my original website.