Low quality of reporting adverse drug reactions in paediatric randomised controlled trials.
OBJECTIVE
Randomised controlled trials (RCT) offer an opportunity to learn about frequency and character of adverse drug reactions. To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs performed in children.


METHODS
Literature search.


RESULTS
The authors found 107 articles on paediatric RCTs written in English and published between 1 January 2006 and 1 April 2009. 83 articles (78%) mentioned adverse drug reactions, 36 articles (34%) used standardised methods for the disclosure of adverse drug reactions, 33 articles (31%) tabulated the reactions, and 27 (25%) stated numbers of and reasons for withdrawal. Registration of the RCT did not influence reporting. Sponsoring did lead to better reporting. According to the Consort guidelines, 19 (18%) reported safety data adequately.


CONCLUSIONS
Reporting of adverse drug reactions in RCTs is often inadequate. Authors should anticipate and define adverse drug reactions. During research all adverse events should be monitored and assessed actively. Monitoring and assessment should be described in articles in accordance with the extended Consort recommendations. Both authors and editors share the responsibility for the improvement of reporting safety data.
de Vries
Tjalling W
TW
Department of Paediatrics, Medical Centre Leeuwarden, H Dunantweg 2, 8934 AD Leeuwarden, The Netherlands. tjalling.de.vries@znb.nl
van Roon
Eric N
EN
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D035843:Biomedical Research / Q000592:standards; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions; D019983:Guideline Adherence; D017408:Guidelines as Topic; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D010372:Pediatrics / Q000592:standards*; D010506:Periodicals as Topic / Q000706:statistics & numerical data; D011643:Publishing / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*