Launch of a European paediatric clinical trials register

Bonati, Maurizio; Pandolfini, Chiara; Rossi, Valentina; Santoro, Eugenio; Bolós, J.; Danés, Imma; Camps, Ignasi; Castel, J M; Jacqz-Aigrain, Évelyne; Zarrabian, S.; Choonara, Imti; Sammons, Helen; Steingo, Joel

doi:10.1185/146300904x2425

Cited by 10 publications

(12 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Furthermore, they do so in a closely monitored, controlled environment and avoid subjecting young patients to ''trial and error'' procedures unnecessarily [4,59]. It is therefore important that the number of paediatric trials increases and that the resulting information be collected, analysed, and made available [8,35,65].…”

Section: Discussionmentioning

confidence: 99%

A literature review on off-label drug use in children

2005

Self Cite

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

A literature review on off-label drug use in children

2005

Self Cite

View full text Add to dashboard Cite

show abstract

“…DEC-net was the only international register dedicated to the paediatric population [27,28], and it was aimed at giving paediatric trials more visibility and facilitating the search for such trials on the part of the public and researchers. With the international initiatives aimed at increasing the importance of suitable registers and making paediatric data accessible, however, such a register is no longer necessary.…”

Section: Discussionmentioning

confidence: 99%

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

Pandolfini

Bonati

2009

Eur J Clin Pharmacol

View full text Add to dashboard Cite

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.

show abstract

“…Recently, data from a European register21 on paediatric drug therapy trials were used to assess the paediatric research situation in Europe. The trial data were analysed22 and, although limited, were used to identify research’s priority areas as well as the areas omitted.…”

Section: Reasons For Registersmentioning

confidence: 99%