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The CPMP Points to Consider on Adjustment for Baseline Covariates recently came into operation. As well as providing sound guidance, this document states a strong position against dynamic allocation. This paper reviews the most important issues involved and aims to stimulate interest in further investigating alternative allocation methods in clinical trials. Copyright © 2004 John Wiley & Sons, Ltd.

Results are presented from a meta-analysis performed on short-term efficacy data from five randomized, double-blind, amitriptyline-controlled studies of Org 3770. All participating patients (n = 814) had a DSM III diagnosis of moderate or severe Major Depressive Episode, and the majority of them was hospitalized. Efficacy of treatments was compared on an Intent-to-Treat basis; 732 patients were available for this type of analysis. Primary efficacy variables were changes from baseline in group mean 17-item HAMD scores and percentages of responders. The results of the meta-analysis are in agreement with those from individual studies, consistently showing that there are no statistically nor clinically relevant differences in efficacy of Org 3770 and amitriptyline throughout the study period and at endpoint.