Child Versus Adult Research: The Gap in High-Quality Study Design

Abstract

In 6 leading generalist and specialist journals, studies involving adults were significantly more likely than child studies to be randomized, controlled trials, systematic reviews, or studies of therapies. If such studies are to be viewed as the highest possible quality of evidence, then this difference has implications for quality of care for children and for funding and future directions in clinical research involving children.

Clinical trials in children

“…Recent advances in multicentre cancer trials in children have increased childhood cancer 5 year survival from 28% in the late 1960s to 79% by 2005 [10][11][12][13]. Regrettably, these stories of remarkable benefits cannot be extended to many other childhood conditions [14] because of the dearth of relevant trials.…”

Fewer infants than older patients in paediatric randomised controlled trials

“…We arbitrarily chose to select a random sample of 35% of the PRCTs published in 2006, in keeping with an earlier study, [20] instead of a 3-month sample. [11] We used a computer-based random selection strategy stratified on journal category. This strategy selected 31 articles in GMJs, 60 in PMJs, and 53 in SMJs (144 articles in all).…”

“…A review of articles published in 2005 in six leading general and specialist journals showed that studies performed in adults were significantly more likely than paediatric studies to be RCTs, systematic reviews, or studies of therapeutic interventions. [11] Compared to studies in adults, studies in paediatric patients are fewer, less well designed, and less well reported. [12] In addition to this previously described paucity of high-quality paediatric studies, we found that few paediatric studies focused on the youngest patients.…”

“…However, only data published in peer-reviewed journals are likely to have a major impact on clinical practice. [11,33] Labelling issues constitute only the most visible part of the far-reaching deficiencies that characterize paediatric clinical research. Because the rules applying to drug use are more restrictive than in other fields (e.g., there is no equivalent of labelling in surgery), the imbalance in labelling between adults and children and across paediatric age groups is more easily recognizable, compared to other problems affecting paediatric research.…”

“…Nevertheless, many studies indicate that the number of high-quality randomised controlled trials (RCTs) remains lower in paediatric patients than in adults. [11][12][13] For example, among the 32 RCTs investigating antiepileptic drugs for the add-on treatment of drug-resistant partial epilepsy, only 5 involved evaluations in both children and adults. [14] Studies that focus specifically on the paediatric population are crucial.…”