Article type
Year
Abstract
Background: As children are a vulnerable population, it is essential to avoid unnecessary trials when enough evidence is available.
Objectives: Our objective was to identify unnecessary repetitions of randomized clinical trials (RCTs) in the pediatric population, using cumulative meta-analyses, when either the beneficial or deleterious effect of the treatment has been confirmed.
Methods: We searched three electronic databases for meta-analyses. Double-blind, placebo–controlled RCTs including adults and children were eligible. The random-effects model was used to pool effect over time by including studies according to their year of publication. We performed cumulative meta-analysis to identify significant benefit or risk when multiple RCTs were available for children.
Results: Initially 89 meta-analyses were identified, including 992 RCTs amongst which only 294 were in children and evaluating 124 drugs. For 53 drugs, only one pediatric trial was included. Ten drugs for the same indication and with the same outcome were evaluated by more than one meta-analysis. Ondansetron for postoperative nausea and vomiting was assessed by 27 pediatric RCTs. The treatment benefit was confirmed in 1995 (Figure 1). Cumulative meta-analysis showed that 19 trials, which included 840 children, were unnecessary.
Conclusions: Our preliminary results suggest the presence in the literature of reports of unnecessary RCTs in children. Clinical research in children should focus on unmet needs and avoid exposing children to unnecessary trials.
Objectives: Our objective was to identify unnecessary repetitions of randomized clinical trials (RCTs) in the pediatric population, using cumulative meta-analyses, when either the beneficial or deleterious effect of the treatment has been confirmed.
Methods: We searched three electronic databases for meta-analyses. Double-blind, placebo–controlled RCTs including adults and children were eligible. The random-effects model was used to pool effect over time by including studies according to their year of publication. We performed cumulative meta-analysis to identify significant benefit or risk when multiple RCTs were available for children.
Results: Initially 89 meta-analyses were identified, including 992 RCTs amongst which only 294 were in children and evaluating 124 drugs. For 53 drugs, only one pediatric trial was included. Ten drugs for the same indication and with the same outcome were evaluated by more than one meta-analysis. Ondansetron for postoperative nausea and vomiting was assessed by 27 pediatric RCTs. The treatment benefit was confirmed in 1995 (Figure 1). Cumulative meta-analysis showed that 19 trials, which included 840 children, were unnecessary.
Conclusions: Our preliminary results suggest the presence in the literature of reports of unnecessary RCTs in children. Clinical research in children should focus on unmet needs and avoid exposing children to unnecessary trials.