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

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European Journal of Clinical Pharmacology Aims and scope Submit manuscript

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.

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Abbreviations

EMEA:

European Medicines Agency

ICMJE:

International Committee of Medical Journal Editors

ICTRP:

International Clinical Trials Registry Platform

MeSH:

Medical Subject Headings

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Authors and Affiliations

  1. Laboratory for Mother and Child Health, Department of Public Health, “Mario Negri” Pharmacological Research Institute, Via Giuseppe La Masa 19, 20156, Milan, Italy

    C. Pandolfini & M. Bonati

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  1. C. Pandolfini
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  2. M. Bonati
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Correspondence to M. Bonati.

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Pandolfini, C., Bonati, M. Children’s presence in research. A review of online registers. Eur J Clin Pharmacol 65, 873–880 (2009). https://doi.org/10.1007/s00228-009-0687-7

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  • DOI: https://doi.org/10.1007/s00228-009-0687-7

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