RT Journal Article
SR Electronic
T1 Low quality of reporting adverse drug reactions in paediatric randomised controlled trials
JF Archives of Disease in Childhood
JO Arch Dis Child
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP 1023
OP 1026
DO 10.1136/adc.2009.175562
VO 95
IS 12
A1 de Vries, Tjalling W
A1 van Roon, Eric N
YR 2010
UL http://adc.bmj.com/content/95/12/1023.abstract
AB 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.