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Low quality of reporting adverse drug reactions in paediatric randomised controlled trials
  1. Tjalling W de Vries1,
  2. Eric N van Roon2
  1. 1Department of Paediatrics, Medical Centre Leeuwarden, Leeuwarden, The Netherlands
  2. 2Department of Clinical Pharmacy, Medical Centre Leeuwarden, Leeuwarden, The Netherlands
  1. Correspondence to Dr Tjalling W de Vries, Paediatrician, Department of Paediatrics, Medical Centre Leeuwarden, H Dunantweg 2, 8934 AD Leeuwarden, The Netherlands;{at}


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.

Design 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.

Conclusion 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.

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  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.