The assessment of sample size in clinical trials comparing population
means requires a variance estimate of the main efficacy variable. When
this variance estimate has a low precision, it may be appropriate to
use the data from the first patients entered in the trial ('internal p
ilot study') to estimate the sample size. We suggest a method for dete
rmining the size of internal pilot studies, which aims at ensuring tha
t this size is as large as possible, but not larger than 'the optimal
size' of the planned study. Advantages and limitations of the method a
re discussed.