Most tumour necrosis factor inhibitor trials in rheumatology are undeservedly called efficacy and safety trials: a survey of power considerations
RHEUMATOLOGY, vol.47, no.7, pp.1054-1057, 2008 (SCI-Expanded, Scopus)
- 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.