This paper reviews some of the issues involved in the planning and executio
n of studies to assess the effect of different follow-up strategies for col
orectal cancer patients. Mathematical models and many previous studies have
failed to indicate strong support for the hypothesis that extensive follow
-up leads to an increase in survival rates. In order to assess the best fol
low-up strategies, at present, within the different Dukes' stages, extremel
y large trials are required and none of the previous studies have satisfied
this criterion, though recently planned studies will, if recruitment targe
ts are met. The large number of patients required, the length of time the s
tudy must run, existing accepted follow-up practices in different countries
, and the difficulty of managing patients on different follow-up strategies
within the same centre all pose problems for the design of a randomized tr
ial. These are not insurmountable, but do contribute to a possible downfall
of a large multicentre randomized trial of follow-up strategies. Although
such a trial will require considerable international cooperation it will ha
ve enormous benefits and implications if it is managed and completed succes
sfully. (C) 2000 Harcourt Publishers Ltd.