Safety in paediatric clinical trials – a 7-year review

doi:10.1111/j.1651-2227.2008.00676.x

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Wiley InterScience

Acta Pædiatrica

Volume 97 Issue 4, Pages 474 - 477

Published Online: 28 Feb 2008

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Safety in paediatric clinical trials – a 7-year review

HM Sammons ¹ , C Gray ¹ , H Hudson ¹ , J Cherrill ¹ , I Choonara ¹

1.Academic Division of Child Health, The Medical School, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3DT, UK

Correspondence
Helen Mary Sammons, Clinical Associate Professor in Child Health, Academic Division of Child Health, The Medical School, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3DT, UK. Tel: 00-44-1332-724694 | Fax: 00-44-1332-724697 | Email: Helen.sammons@nottingham.ac.uk

KEYWORDS

Adverse drug reaction • Child • Clinical trial

ABSTRACT

Aim: The safety of clinical trials in children has not been previously studied. We aimed to identify how safety is monitored and the extent of adverse drug reactions (ADRs).

Methods: A literature review of the Medline Database for therapeutic clinical trials involving oral and intravenous medicines in children from 1996 to 2002. Papers were read to determine the safety monitoring and the presence of adverse events (AEs) or ADRs.

Results: Seven hundred thirty-nine trials were identified. Thirteen (2%) had safety monitoring committees (SMCs). Five hundred twenty-three (71%) trials reported AEs and 151 (20%) of these trials reported a serious AE. ADRs were present in 270 (36.5%) trials, with 80 (11%) of trials having a moderate or severe ADR. Six clinical trials were terminated early because of significant drug toxicity. All of these had SMCs. There were deaths in 83 (11%) trials. In the majority of trials, mortality was thought to be unrelated to the investigational drug; however, in two trials mortality was higher in the treatment group.

Conclusions: About 11% of trials have a moderate or severe ADR. All paediatric clinical trials should have a SMC.

Received
2 July 2007; revised 19 November 2007; accepted 4 December 2007.

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1651-2227.2008.00676.x About DOI