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


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Yazici Y., Adler N. M. , Yazici H.

RHEUMATOLOGY, cilt.47, ss.1054-1057, 2008 (SCI İndekslerine Giren Dergi)

  • Cilt numarası: 47 Konu: 7
  • Basım Tarihi: 2008
  • Doi Numarası: 10.1093/rheumatology/ken190
  • Dergi Adı: RHEUMATOLOGY
  • Sayfa Sayısı: ss.1054-1057

Özet

Objectives: 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.