The Pharmaceutical Journal
Vol 280 No 7495 p352
29 March 2008

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Independent safety review lacking in paediatric trials

Only 2 per cent of paediatric clinical trials include independent safety monitoring, a seven-year review suggests (Acta Paediatrica 2008;97:474).

Researchers from the University of Nottingham’s academic division of child health analysed 739 trials, published between 1996 and 2002, that examined therapeutic use of oral and intravenous medicines in children. They found that 71 per cent of the trials reported adverse events, 20 per cent of which reported serious adverse events. Adverse drug reactions were recorded in 36.5 per cent of trials and 11 per cent had a moderate or severe ADR. Although 74 per cent of the trials described how safety monitoring was performed during the study, only 13 (2 per cent) had independent safety monitoring committees.

Having “an independent monitor who has the ability to swiftly question any ADRs or inequalities in morbidity or mortality is essential”, the researchers say. They report that six of the trials included in the review were terminated early due to drug toxicity and all of these had independent safety monitoring committees.

Lead author Helen Sammons, clinical associate professor in child health, based at Derbyshire Children’s Hospital, added that although “all trials have safety checks by the trial team and report adverse events to the regulatory authorities”, an independent safety monitoring committee, which can look at any reactions without bias, “is an important extra step to safeguard safety”.

Commenting on the review, Ian Wong, director and professor of paediatric medicines research, Centre for Paediatric Pharmacy Research, London, said that the number of trials reported to have a safety monitoring committee was unusually low and may reflect old practice or that simply the investigators did not report them in their publications.

“ Nevertheless, good clinical practice recommends clinical trials set up an independent data monitoring committee to review the accruing trial data and to assess whether there are any safety issues that should be brought to participants’ attention or any reasons for the trial not to continue,” said Professor Wong.

Richard Ley, a spokesman for the Association of the British Pharmaceutical Industry, told The Journal: “If you are conducting a small trial in one centre or a couple of centres you do not need an independent data safety monitoring board. It is not necessary. Where companies would consider setting up such a body is if there was a large trial over many sites, perhaps in many different countries, and then a safety committee could be a valuable tool.” He also pointed out that there is a regulatory requirement on people conducting clinical trials to report ADRs within 15 days of them occurring.

Drug companies want to be doing everything they can to ensure safety but it is down to them to decide whether or not to have an independent safety monitoring committee, he added.