PMID- 21858432
OWN - NLM
STAT- MEDLINE
DCOM- 20120501
LR  - 20211020
IS  - 1432-1041 (Electronic)
IS  - 0031-6970 (Print)
IS  - 0031-6970 (Linking)
VI  - 68
IP  - 2
DP  - 2012 Feb
TI  - Systematic review of safety in paediatric drug trials published in 2007.
PG  - 189-94
LID - 10.1007/s00228-011-1112-6 [doi]
AB  - BACKGROUND: There is now greater involvement of children in drug trials to ensure 
      that paediatric medicines are supported by sound scientific evidence. The safety 
      of the participating children is of paramount importance. Previous research shows 
      that these children can suffer moderate and severe adverse drug reactions (ADRs) 
      in clinical trials, yet very few of the trials designated a data safety 
      monitoring board (DSMB) to oversee the trial. METHODS: Safety data from a 
      systematic review of paediatric drug randomised controlled trials (RCTs) 
      published in 2007 were analysed. All reported adverse events (AEs) were 
      classified and assessed to determine whether an ADR had been experienced. ADRs 
      were then categorised according to severity. Each trial report was examined as to 
      whether an independent DSMB was in place. RESULTS: Of the 582 paediatric drug 
      RCTs analysed, 210 (36%) reported that a serious AE had occurred, and in 15% 
      mortality was reported. ADRs were detected in more than half of the RCTs (305); 
      66 (11%) were severe, and 79 (14%) were moderate. Severe ADRs involved a wide 
      range of organ systems and were frequently associated with cytotoxic drugs, 
      antiparasitics, anticonvulsants and psychotropic drugs. Two RCTs reported 
      significantly higher mortality rates in the treatment group. Only 69 (12%) of the 
      RCTs stated there was a DSMB. DSMBs terminated five RCTs and changed the protocol 
      in one. CONCLUSIONS: Children participating in drug RCTs experience a significant 
      amount and a wide range of ADRs. DSMBs are needed to ensure the safety of 
      paediatric participants in clinical drug trials.
FAU - Nor Aripin, Khairun Nain Bin
AU  - Nor Aripin KN
AD  - Academic Division of Child Health, University of Nottingham, Derbyshire 
      Children's Hospital, Derby, UK. khairun@usim.edu.my
FAU - Choonara, Imti
AU  - Choonara I
FAU - Sammons, Helen M
AU  - Sammons HM
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20110820
PL  - Germany
TA  - Eur J Clin Pharmacol
JT  - European journal of clinical pharmacology
JID - 1256165
SB  - IM
MH  - Clinical Trials Data Monitoring Committees
MH  - Clinical Trials as Topic/*statistics & numerical data
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Pediatrics/*statistics & numerical data
PMC - PMC3256313
EDAT- 2011/08/23 06:00
MHDA- 2012/05/02 06:00
PMCR- 2011/08/20
CRDT- 2011/08/23 06:00
PHST- 2011/04/01 00:00 [received]
PHST- 2011/07/27 00:00 [accepted]
PHST- 2011/08/23 06:00 [entrez]
PHST- 2011/08/23 06:00 [pubmed]
PHST- 2012/05/02 06:00 [medline]
PHST- 2011/08/20 00:00 [pmc-release]
AID - 1112 [pii]
AID - 10.1007/s00228-011-1112-6 [doi]
PST - ppublish
SO  - Eur J Clin Pharmacol. 2012 Feb;68(2):189-94. doi: 10.1007/s00228-011-1112-6. Epub 
      2011 Aug 20.