EAP viewpoint on unpublished data from paediatric clinical trials. 2018

L Schrier, and K Illy, and A Valiulis, and C Wyder, and T Stiris
Department of Paediatrics, Willem Alexander Children's Hospital, Leiden University Medical Center, Leiden, The Netherlands. l.schrier@lumc.nl.

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 Industry-sponsored trials are more likely to remain unpublished, and take longer to get published compared with trials sponsored by others.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

UI MeSH Term Description Entries
D010372 Pediatrics A medical specialty concerned with maintaining health and providing medical care to children from birth to adolescence.
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D005060 Europe The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN. Northern Europe,Southern Europe,Western Europe
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical
D017594 Publication Bias The influence of study results on the chances of publication and the tendency of investigators, reviewers, and editors to submit or accept manuscripts for publication based on the direction or strength of the study findings. Publication bias has an impact on the interpretation of clinical trials and meta-analyses. Bias can be minimized by insistence by editors on high-quality research, thorough literature reviews, acknowledgement of conflicts of interest, modification of peer review practices, etc. Bias, Publication
D022126 Access to Information Individual's rights to obtain and use information collected or generated by others. FOIA Requests,Freedom of Information Act Requests,Open Access to Information,Public Access to Information,FOIA Request,Information, Access to,Request, FOIA,Requests, FOIA
D033181 Information Dissemination The circulation or wide dispersal of information. Data Sharing,Information Distribution,Information Sharing,Data Sharings,Dissemination, Information,Distribution, Information,Information Sharings,Sharing, Data,Sharing, Information,Sharings, Data,Sharings, Information

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