ABSTRACT

Clinical trials are often multicentric, that is, patients are recruited in several

centers (medical practices or hospitals). In so doing, a larger sample size is

possible, among other things. A disadvantage, however, is the possibility of

differences between the centers. Therefore, the randomization of patients is

usually done separately for every center in order to have in each center a

similar allocation of patients to the different treatments. A consequence for

the statistical analysis is that the stratification by center must be considered

(EMEA, 2003).