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EDITOR
Barbert and Thompson's study is welcome if it leads trial
designers to recognise health economics as more than a (non-essential) afterthought to their trial.1 The points that the authors
make would benefit from a more complete understanding of the nature of
economic data and the context in which economic analyses are undertaken.2
Clinical outcomes in trials tend to be uni-dimensional and unambiguous
(such as survival or response to treatment), whereas economic data are
essentially multidimensional. Health care embraces the use of a
multitude of resources, each measured in different units and attracting
its own distinct pricing regime. The economic aspect of a typical
clinical trial will require information to be collected for 20-30 such
items, each subject to a different statistical distribution.
Theoretically, sample size should be calculated for each of these and
the trial's recruitment target determined as that of the largest. But
this requires knowledge of the