Efficacy of experimental treatments compared with standard treatments in non-inferiority trials: A meta-analysis of randomized controlled trials. - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue International Journal of Epidemiology Année : 2010

Efficacy of experimental treatments compared with standard treatments in non-inferiority trials: A meta-analysis of randomized controlled trials.

Rutger A Middelburg
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Matthias Egger
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Jp Vandenbroucke
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Olaf M Dekkers
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Résumé

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. 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. Trials were identified in a search of PubMed (1991 to February 20, 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% CI 0.978 to 1.010) using a random effects model and 1.002 (95% CI 0.996 to 1.008) using a fixed-effects model. Of the 175 comparisons, experimental treatment was considered to be non-inferior in 130 (74%). The combined relative risk for these 130 comparisons was 0.995 (95% CI 0.983 to 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 (interquartile range [IQR] 1.18 to 1.59). Conclusion In this meta-analysis of non-inferiority trials the average relative risk 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.

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Dates et versions

hal-00622880 , version 1 (13-09-2011)

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Darius Soonawala, Rutger A Middelburg, Matthias Egger, Jp Vandenbroucke, Olaf M Dekkers. Efficacy of experimental treatments compared with standard treatments in non-inferiority trials: A meta-analysis of randomized controlled trials.. International Journal of Epidemiology, 2010, 39 (6), pp.1567. ⟨10.1093/ije/DYQ136⟩. ⟨hal-00622880⟩

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