EAP viewpoint on unpublished data from paediatric clinical trials

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

Abstract

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 Industry-sponsored trials are more likely to remain unpublished, and take longer to get published compared with trials sponsored by others.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

Abbreviations

BMJ

British Medical Journal

EAP

European Academy of Paediatrics

EMA

European Medicines Agency

GPP

Good publication practice

RCT

Randomised controlled trial

SSRI

Selective serotonin reuptake inhibitor

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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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