Different treatment benefits were estimated by clinical trials performed in adults compared with those performed in children

J Clin Epidemiol. 2015 Oct;68(10):1221-31. doi: 10.1016/j.jclinepi.2015.06.021. Epub 2015 Jul 9.

Abstract

Objective: Our main objective was to see whether the therapeutic benefit observed in placebo controlled randomized controlled trials (RCTs) is different between adults and children.

Study design and setting: We searched three electronic databases for meta-analyses that included double-blind, placebo-controlled RCTs with separate results for adults and children. The selected reviews were classified according to disease and drug used. The heterogeneity of treatment response between adults and children was measured using ratio of odds ratios (RORs).

Results: We selected 89 meta-analyses and calculated RORs for 124 drugs. Heterogeneity in the direction of the treatment effect was observed in one drug and heterogeneity in the quantity of the treatment effect for 13 drugs, indicating significantly different treatment effect in adults when compared with children. RORs were not significantly different from 1 for 110 drugs. For 36 of these drugs, the treatment effect was confirmed in both populations.

Conclusion: We found different treatment benefits estimated by clinical trials performed in adults compared with those performed in children for 14 of 124 drugs. Data on dose adjustment and child age groups from RCTs were not adequately reported to investigate their influence on the treatment benefit dissimilarities.

Keywords: Adults; Data reporting; Extrapolation; Meta-epidemiological study; Pediatrics; Treatment benefit.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Adult
  • Age Factors
  • Child
  • Clinical Trials as Topic*
  • Humans
  • Treatment Outcome