Minimization in crossover trials with non-prognostic strata: theory and practical application

Citation
H. Green et al., Minimization in crossover trials with non-prognostic strata: theory and practical application, J CLIN PH T, 26(2), 2001, pp. 121-128
Citations number
21
Categorie Soggetti
Pharmacology
Journal title
JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS
ISSN journal
02694727 → ACNP
Volume
26
Issue
2
Year of publication
2001
Pages
121 - 128
Database
ISI
SICI code
0269-4727(200104)26:2<121:MICTWN>2.0.ZU;2-C
Abstract
To obtain meaningful results in any clinical trial, patients need to be all ocated to treatments in such a way that valid analysis can be carried out. Balancing treatment groups before analysis is carried out is more desirable than trying to compensate for incomparability at a later date. Therefore, the development of allocation procedures to produce comparable groups in wh ich prognostic factors are equally represented is important. Minimization, a deterministic allocation method, aims to ensure balance on such factors, particularly in small trials when traditional randomization methods are lik ely to fail. However, views on the use of conventional analysis following m inimization are divided. The use of minimization in two randomised crossove r trials is described where, in addition to the comparisons between randomi sed treatments, it was desired to have balance between groups based on diff erential trial procedures. Theoretical concerns about the use of minimizati on are not applicable in this setting, and therefore minimization is shown to be a useful technique for obtaining balance.