Patient preferences and randomised clinical trials

Abstract

Allocating patients to different treatments by randomisation in a controlled trial is now accepted almost without question in accounts of trial design. Randomisation may reasonably be supposed to play a large part in evaluating proposed studies for grant support. The virtue of randomisation is that it reduces some types of systematic error that may interfere with the interpretation of the results of a trial. Allocating patients to treatments in a systematic non-randomised way may introduce bias which destroys comparability. We argue here that despite this advantage random allocation is not always suitable. Though patients play an active part in the outcome of all treatments, we suggests that clinical trials in which they are required to sustain an effortful and demanding role and those in which they are likely to have strong preferences for one treatment need to be considered and conducted differently.