In an increasing number of recent major clinical trials, independent s
afety committees or safety monitors have been involved. Their role and
function is not yet defined and continues to evolve. The aim of this
paper is to discuss the role and tasks of safety committees as a resul
t of our collective experience as members of three safety committees o
f studies evaluating antithrombotic prophylaxis against postoperative
deep vein thrombosis. We believe that the type of pharmacological inte
rvention used is of less important that the general experiences gained
, which can be extrapolated to other studies and should stimulate a mo
re general debate.