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EAP viewpoint on unpublished data from paediatric clinical trials

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 Industry-sponsored trials are more likely to remain unpublished, and take longer to get published compared with trials sponsored by others.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

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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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Author information

Authors and Affiliations

  1. Department of Paediatrics, Willem Alexander Children’s Hospital, Leiden University Medical Center, Leiden, The Netherlands

    L. Schrier

  2. Department of Paediatrics, Rivierenland Hospital, Tiel, The Netherlands

    K. Illy

  3. Vilnius University Clinic of Children’s Diseases and Public Health Institute, Vilnius, Lithuania

    A. Valiulis

  4. Paediatric Primary Care Center Kurwerk, Burgdorf, Switzerland

    C. Wyder

  5. Department of Neonatology, Oslo University Hospital, Oslo, Norway

    T. Stiris

  6. Faculty of Medicine, University of Oslo, Oslo, Norway

    T. Stiris

Authors
  1. L. Schrier
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  2. K. Illy
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  3. A. Valiulis
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  4. C. Wyder
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  5. T. Stiris
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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.

Corresponding author

Correspondence to L. Schrier.

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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.

Additional information

Communicated by Peter de Winter

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Schrier, L., Illy, K., Valiulis, A. et al. EAP viewpoint on unpublished data from paediatric clinical trials. Eur J Pediatr 177, 275–277 (2018). https://doi.org/10.1007/s00431-017-3005-x

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  • DOI: https://doi.org/10.1007/s00431-017-3005-x

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