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Many randomized clinical trials (RCTs) are labelled efficacy and safety while due consideration for power is provided only for efficacy outcomes. This in turn necessitates a discussion of the inadequacy of sample size (type II error) for identifying harm. This is particularly important in RCTs of TNF inhibitors as harm related to these agents is still a matter of debate.

Most tumour necrosis factor inhibitor trials in rheumatology are undeservedly called 'efficacy and safety' trials: a survey of power considerations