Most tumour necrosis factor inhibitor trials in rheumatology are undeservedly called efficacy and safety trials: a survey of power considerations
RHEUMATOLOGY, cilt.47, sa.7, ss.1054-1057, 2008 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 47 Sayı: 7
- Basım Tarihi: 2008
- Doi Numarası: 10.1093/rheumatology/ken190
- Dergi Adı: RHEUMATOLOGY
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
- Sayfa Sayıları: ss.1054-1057
- İstanbul Üniversitesi Adresli: Evet
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.