European Journal of Pediatrics

, Volume 177, Issue 2, pp 275–277 | Cite as

EAP viewpoint on unpublished data from paediatric clinical trials

  • L. Schrier
  • K. Illy
  • A. Valiulis
  • C. Wyder
  • T. Stiris
EAP Statement


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 Industry-sponsored trials are more likely to remain unpublished, and take longer to get published compared with trials sponsored by others.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


Authors’ contributions

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.

Ethical approval

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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Copyright information

© Springer-Verlag GmbH Germany 2017

Authors and Affiliations

  1. 1.Department of PaediatricsWillem Alexander Children’s Hospital, Leiden University Medical CenterLeidenThe Netherlands
  2. 2.Department of PaediatricsRivierenland HospitalTielThe Netherlands
  3. 3.Vilnius University Clinic of Children’s Diseases and Public Health InstituteVilniusLithuania
  4. 4.Paediatric Primary Care Center KurwerkBurgdorfSwitzerland
  5. 5.Department of NeonatologyOslo University HospitalOsloNorway
  6. 6.Faculty of MedicineUniversity of OsloOsloNorway

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