Children’s presence in research. A review of online registers

Abstract

Objectives To determine how many online clinical trial registers include paediatric trial data, how much information is provided, ease of searching for paediatric trials and the accessibility of paediatric trial data in general. Methods Medline and Google were searched for mention of clinical trial registers in July 2008. All registers considered to be eligible were evaluated for trial information provided, search options available, and number of trials, both total and paediatric. A meta-analytic weighted average of the presence of paediatric trials was calculated and compared to the percentage of published paediatric trial articles in Medline. The paediatric trials in the registers were searched for in the World Health Organization's International Clinical Trials Registry Platform (ICTRP). All online, freely accessible registers including ongoing trials on different drugs or therapeutic areas, were eligible for review. Results Twelve registers were included in the review. All except one provided detailed trial data, while search options varied between registers: seven provided free-text searching, two listed their trials by condition, two provided elaborate search options (age group, condition, study purpose, etc) and one simply listed its trials. Nine of the 12 registers' search facilities made it possible to search for paediatric trials, and these were analysed further: the percentage of paediatric trials in the single registers ranged from 4.8 to 33.3%, and the weighted average was 15% (95% confidence interval 8.2-21.8). The percentage of published, paediatric trial articles was 25%. Of the paediatric trials also searched for in the ICTRP, 66% were found. Conclusions Great difficulty was found in retrieving paediatric trials due to the limited and inadequate search functions of the registers reviewed but, in general, the registers seem to represent fewer paediatric trials than those reported in the literature. The ICTRP portal is important for trial accessibility, but it is still in an initial phase and far from representative of the global research situation, especially in the field of paediatrics.

A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007

“…However, trial registration is far from universal, and is perhaps more problematic in pediatric trials. Pandolfini and Bonati [29] found that the proportion of pediatric trials among all registered trials in online registers was disproportionate to those in the published literature. Pediatric trials are more likely to be published in specialty journals which may be less likely to require trial registration than general medical journals.…”

Controlled Trials in Children: Quantity, Methodological Quality and Descriptive Characteristics of Pediatric Controlled Trials Published 1948-2006

“…Recent work analysing the rate of registration of pediatric trials suggests that authors of pediatric trials have been slow to prospectively register their studies, despite the fact that many journals stipulate that prospective registration is a prerequisite for publication[28], [29]. Therefore it seems likely that analysing the number of registered trials would substantially underestimate the number of trials actually being conducted.…”