Cross‐over trials in Statistics in Medicine: the first ‘25’ years

Papers on cross-over trials that have appeared in the first 25 years of Statistics in Medicine are reviewed. Papers on bioequivalence are also considered. After a brief statistical summary, individual papers are discussed under seven headings: 1. The two-stage analysis of AB/BA trials, 2. Baselines, 3. Binary and categorical data, 4. Survival data, 5. Modelling carry-over, 6. Bioequivalence and 7. Components of variation. Finally, a brief assessment of the importance in this field of Statistics in Medicine is given.

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[2]  S Senn,et al.  The AB/BA crossover: past, present and future? , 1994, Statistical methods in medical research.

[3]  J. Baskerville,et al.  Clinical trials designed to evaluate therapeutic preferences. , 1984, Statistics in medicine.

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[6]  J A John,et al.  CrossOver: an algorithm for the construction of efficient cross‐over designs , 2004, Statistics in medicine.

[7]  S Senn,et al.  Robust and realistic approaches to carry-over. , 1998, Statistics in medicine.

[8]  J Norrie,et al.  Model inconsistency, illustrated by the Cox proportional hazards model. , 1995, Statistics in medicine.

[9]  Stephen Senn,et al.  Statistical issues in bioequivalance , 2001 .

[10]  S. Senn.  Statistical Issues in Bioequivalence , 2001 .

[11]  S J Senn,et al.  Is the 'simple carry-over' model useful? , 1992, Statistics in medicine.

[12]  M. Kenward,et al.  The analysis of data from 2 x 2 cross-over trials with baseline measurements. , 1987, Statistics in medicine.

[13]  J Whitehead,et al.  A random effects model for ordinal responses from a crossover trial. , 1991, Statistics in medicine.

[14]  S. Senn.  Individual Therapy: New Dawn or False Dawn? , 2001 .

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[20]  S. Senn.  The case for cross-over trials in phase III. , 1997, Statistics in medicine.

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[22]  S. Senn,et al.  The use of baselines in clinical trials of bronchodilators. , 1989, Statistics in medicine.

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[25]  R. Kempton,et al.  The application of REML in clinical trials. , 1994, Statistics in medicine.

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[27]  P. Freeman.  The performance of the two-stage analysis of two-treatment, two-period crossover trials. , 1989, Statistics in medicine.

[28]  Eric R. Ziegel,et al.  Cross-Over Experiments , 1994 .

[29]  R. Shumaker,et al.  The Phenytoin Trial is a Case Study of ‘Individual’ Bioequivalence , 1998 .

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[36]  S. Senn.  Misunderstandings regarding clinical cross‐over trials , 2005, Statistics in Medicine.

[37]  R J Marshall,et al.  Analysis of case-crossover designs. , 1993, Statistics in medicine.

[38]  Sally Hung-Hsin Lee,et al.  Use of the two-stage procedure for analysis of cross-over trials in four aspects of medical statistics , 2006 .

[39]  V M Chinchilli,et al.  A mixed effects model for the analysis of repeated measures cross-over studies. , 1999, Statistics in medicine.

[40]  M Feingold,et al.  Cross-over trials with censored data. , 1996, Statistics in medicine.

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[44]  W. Hauck,et al.  Types of bioequivalence and related statistical considerations. , 1992, International journal of clinical pharmacology, therapy, and toxicology.

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[47]  Christopher T. Rhodes.  Bioequivalence Evaluation—Possible Future Developments , 1994 .

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[50]  S. Lewis,et al.  Factorial designs for crossover clinical trials. , 1990, Statistics in medicine.

[51]  Philip Hougaard,et al.  Analysis of Multivariate Survival Data , 2001 .

[52]  A random effects model for ordinal responses from a crossover trial , 1991 .

[53]  Wang Sj,et al.  Use of two-stage test statistic in the two-period crossover trials. , 1997 .

[54]  K Y Liang,et al.  An overview of methods for the analysis of longitudinal data. , 1992, Statistics in medicine.

[55]  Walter W. Hauck,et al.  Consideration of individual bioequivalence , 1990, Journal of Pharmacokinetics and Biopharmaceutics.