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


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

RHEUMATOLOGY, vol.47, no.7, pp.1054-1057, 2008 (Journal Indexed in SCI) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 47 Issue: 7
  • Publication Date: 2008
  • Doi Number: 10.1093/rheumatology/ken190
  • Journal Name: RHEUMATOLOGY
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.1054-1057
  • Istanbul University Affiliated: Yes

Abstract

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.