PMID- 18307556
OWN - NLM
STAT- MEDLINE
DCOM- 20080812
LR  - 20220408
IS  - 0803-5253 (Print)
IS  - 0803-5253 (Linking)
VI  - 97
IP  - 4
DP  - 2008 Apr
TI  - Safety in paediatric clinical trials--a 7-year review.
PG  - 474-7
LID - 10.1111/j.1651-2227.2008.00676.x [doi]
AB  - 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.
FAU - Sammons, H M
AU  - Sammons HM
AD  - Academic Division of Child Health, The Medical School, University of Nottingham, 
      Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3DT, UK. 
      Helen.sammons@nottingham.ac.uk
FAU - Gray, C
AU  - Gray C
FAU - Hudson, H
AU  - Hudson H
FAU - Cherrill, J
AU  - Cherrill J
FAU - Choonara, I
AU  - Choonara I
LA  - eng
PT  - Journal Article
DEP - 20080227
PL  - Norway
TA  - Acta Paediatr
JT  - Acta paediatrica (Oslo, Norway : 1992)
JID - 9205968
SB  - IM
MH  - Child
MH  - *Clinical Trials Data Monitoring Committees
MH  - Clinical Trials as Topic/adverse effects/*statistics & numerical data
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Pediatrics/standards
MH  - Safety
EDAT- 2008/03/01 09:00
MHDA- 2008/08/13 09:00
CRDT- 2008/03/01 09:00
PHST- 2008/03/01 09:00 [pubmed]
PHST- 2008/08/13 09:00 [medline]
PHST- 2008/03/01 09:00 [entrez]
AID - APA676 [pii]
AID - 10.1111/j.1651-2227.2008.00676.x [doi]
PST - ppublish
SO  - Acta Paediatr. 2008 Apr;97(4):474-7. doi: 10.1111/j.1651-2227.2008.00676.x. Epub 
      2008 Feb 27.