PMID- 20837637
OWN - NLM
STAT- MEDLINE
DCOM- 20110908
LR  - 20220316
IS  - 1464-3685 (Electronic)
IS  - 0300-5771 (Linking)
VI  - 39
IP  - 6
DP  - 2010 Dec
TI  - Efficacy of experimental treatments compared with standard treatments in 
      non-inferiority trials: a meta-analysis of randomized controlled trials.
PG  - 1567-81
LID - 10.1093/ije/dyq136 [doi]
AB  - BACKGROUND: There is concern that non-inferiority trials might be deliberately 
      designed to conceal that a new treatment is less effective than a standard 
      treatment. In order to test this hypothesis we performed a meta-analysis of 
      non-inferiority trials to assess the average effect of experimental treatments 
      compared with standard treatments. METHODS: One hundred and seventy 
      non-inferiority treatment trials published in 121 core clinical journals were 
      included. The trials were identified through a search of PubMed (1991 to 20 
      February 2009). Combined relative risk (RR) from meta-analysis comparing 
      experimental with standard treatments was the main outcome measure. RESULTS: The 
      170 trials contributed a total of 175 independent comparisons of experimental 
      with standard treatments. The combined RR for all 175 comparisons was 0.994 [95% 
      confidence interval (CI) 0.978-1.010] using a random-effects model and 1.002 (95% 
      CI 0.996-1.008) using a fixed-effects model. Of the 175 comparisons, experimental 
      treatment was considered to be non-inferior in 130 (74%). The combined RR for 
      these 130 comparisons was 0.995 (95% CI 0.983-1.006) and the point estimate 
      favoured the experimental treatment in 58% (n = 76) and standard treatment in 42% 
      (n = 54). The median non-inferiority margin (RR) pre-specified by trialists was 
      1.31 [inter-quartile range (IQR) 1.18-1.59]. CONCLUSION: In this meta-analysis of 
      non-inferiority trials the average RR comparing experimental with standard 
      treatments was close to 1. The experimental treatments that gain a verdict of 
      non-inferiority in published trials do not appear to be systematically less 
      effective than the standard treatments. Importantly, publication bias and bias in 
      the design and reporting of the studies cannot be ruled out and may have skewed 
      the study results in favour of the experimental treatments. Further studies are 
      required to examine the importance of such bias.
FAU - Soonawala, Darius
AU  - Soonawala D
AD  - Department of Clinical Epidemiology, Leiden University Medical Centre, RC Leiden, 
      The Netherlands. d.soonawala@lumc.nl
FAU - Middelburg, Rutger A
AU  - Middelburg RA
FAU - Egger, Matthias
AU  - Egger M
FAU - Vandenbroucke, Jan P
AU  - Vandenbroucke JP
FAU - Dekkers, Olaf M
AU  - Dekkers OM
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20100913
PL  - England
TA  - Int J Epidemiol
JT  - International journal of epidemiology
JID - 7802871
SB  - IM
CIN - Int J Epidemiol. 2010 Dec;39(6):1582-3. PMID: 21113051
MH  - *Data Interpretation, Statistical
MH  - Drug Evaluation/*methods/*standards
MH  - Humans
MH  - Randomized Controlled Trials as Topic/*methods/standards
MH  - Regression Analysis
MH  - Research Design
MH  - Therapeutic Equivalency
EDAT- 2010/09/15 06:00
MHDA- 2011/09/09 06:00
CRDT- 2010/09/15 06:00
PHST- 2010/09/15 06:00 [entrez]
PHST- 2010/09/15 06:00 [pubmed]
PHST- 2011/09/09 06:00 [medline]
AID - dyq136 [pii]
AID - 10.1093/ije/dyq136 [doi]
PST - ppublish
SO  - Int J Epidemiol. 2010 Dec;39(6):1567-81. doi: 10.1093/ije/dyq136. Epub 2010 Sep 
      13.