Trials to assess equivalence: the importance of rigorous methods

BMJ 1996;313:36-39 (6 July)

Education and debate

Trials to assess equivalence: the importance of rigorous methods

B Jones, professor of medical statistics,^a P Jarvis, senior lecturer in medical statistics,^a J A Lewis, visiting professor in medical statistics,^a A F Ebbutt, director of European clinical statistics ^b

^a Department of Medical Statistics, School of Computing Sciences, De Montfort University, Leicester LE1 9BH, ^b Glaxo Wellcome Ltd, Greenford, Middlesex UB6 0HE

Correspondence to: Professor J A Lewis, Medicines Control Agency, London SW8 5NQ.

The aim of an equivalence trial is to show the therapeutic equivalenceof two treatments, usually a new drug under development andan existing drug for the same disease used as a standard activecomparator. Unfortunately the principles that govern the design,conduct, and analysis of equivalence trials are not as wellunderstood as they should be. Consequently such trials ofteninclude too few patients or have intrinsic design biases whichtend towards the conclusion of no difference. In addition theapplication of hypothesis testing in analysing and interpretingdata from such trials sometimes compounds the drawing of inappropriateconclusions, and the inclusion and exclusion of patients fromanalysis may be poorly managed.

The design of equivalence trials should mirror that of . . . [Full text of this article]

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