Patient preferences and randomised clinical trials.

Abstract

Allocating patients to different treatments by randomisation in a\ncontrolled trial is now accepted almost without question in accounts of trial\ndesign. Randomisation may reasonably be supposed to play a large part in\nevaluating proposed studies for grant support. The virtue of randomisation is\nthat it reduces some types of systematic error that may interfere with the\ninterpretation of the results of a trial. Allocating patients to treatments\nin a systematic non-randomised way may introduce bias which destroys\ncomparability. We argue here that despite this advantage random allocation is\nnot always suitable. Though patients play an active part in the outcome of\nall treatments, we suggest that clinical trials in which they are required to\nsustain an effortful and demanding role and those in which they are likely to\nhave strong preferences for one treatment need to be considered and conducted\ndifferently.