EAP viewpoint on unpublished data from paediatric clinical trials
European children and paediatricians rely heavily on the fair, complete and timely publication of data obtained from paediatric randomised controlled trials (RCTs). Selective publication and reporting of paediatric RCTs is common practice. Industry-sponsored trials are more likely to remain unpublished, and take longer to get published compared with trials sponsored by others. However, also academic sponsors contribute to inefficiencies in publishing clinical data. Publication bias violates the ethical obligation that investigators have towards study participants, leads to considerable inefficiencies in research and a waste of financial and human resources, and has the potential to distort evidence for treatment approaches.
Conclusion: The European Academy of Paediatrics (EAP) therefore actively supports initiatives that increase the public dissemination of paediatric clinical trial data. The EAP will raise awareness about the guidelines for Good Publication Practice among European paediatricians and subspecialty societies.
British Medical Journal
European Academy of Paediatrics
European Medicines Agency
Good publication practice
Randomised controlled trial
Selective serotonin reuptake inhibitor
Tom Stiris initiated the EAP viewpoint, commented on the draft and agreed on its final wording. Lenneke Schrier wrote the draft, included revisions from co-authors and agreed on its final wording. Karoly Illy commented on the draft and agreed on its final wording. Arunas Valiulis commented on the draft and agreed on its final wording. Corinne Wyder commented on the draft and agreed on its final wording.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
This article does not contain any studies with human participants performed by any of the authors. Therefore, obtaining informed consent was not applicable, nor are funded studies included.
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