Therapeutic equivalence: fallacies and falsification
- 5 February 2003
- journal article
- research article
- Published by Wiley in Statistics in Medicine
- Vol. 22 (5) , 741-762
- https://doi.org/10.1002/sim.1360
Abstract
The number of studies designed specifically to demonstrate therapeutic equivalence or alternatively non‐inferiority of pharmaceutical treatments has increased dramatically in recent years, during which time awareness of the methodological issues has increased. Regulatory authorities have been quick to recognize the need for specific support and have either published or initiated the creation of relevant guidance. Common misconceptions prevail however regarding sample size estimation and the choice of the most appropriate patient population to analyse while other areas such as equivalence margin specification and covariate adjustment have been neglected. This paper challenges some of the regulatory advice and the interpretation that others have made of this guidance with the aim of stimulating further debate. Copyright © 2003 John Wiley & Sons, Ltd.Keywords
This publication has 24 references indexed in Scilit:
- Statistical issues in bioequivalanceStatistics in Medicine, 2001
- Consensus and Controversy in Pharmaceutical StatisticsJournal of the Royal Statistical Society: Series D (The Statistician), 2000
- Simple methods for checking for possible errors in reported odds ratios, relative risks and confidence intervalsStatistics in Medicine, 1999
- The effects of covariate adjustment in generalized linear modelsCommunications in Statistics - Theory and Methods, 1998
- On the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpointsJournal of Biopharmaceutical Statistics, 1998
- Sample size calculations for ordered categorical dataStatistics in Medicine, 1993
- Falsificationism and clinical trialsStatistics in Medicine, 1991
- The Effects of Misclassification on the Bias in the Difference Between Two Proportions and the Relative Odds in the Fourfold TableJournal of the American Statistical Association, 1975
- Generalized Linear ModelsJournal of the Royal Statistical Society. Series A (General), 1972