The UK research team that was led by Helen Sammons, a clinical associate professor in child health at the University of Nottingham’s Medical School, carried out a detailed investigation of 739 paediatric trials published between 1996 and 2002, to assess the safety measures that were adopted to monitor adverse drug reactions that arise in the trials. The team found that while 74% of the papers described how safety monitoring was conducted during the study, only 2% – 13 out of 739 trials – had independent safety monitoring committees.
The studies that reported severe drug toxicity problems came from a wide range of countries like China, France, Taiwan, Thailand, India, Israel, Italy, Japan, the Netherlands, Argentina, Belgium, Canada, Chile, South Africa, Sweden, Turkey, the UK and the US. The research team only assessed papers that were published in English in the Medline database during the seven-year study period and excluded HIV and cancer trials because of the high death rates associated with these diseases.
According to the researchers, inclusion of independent safety monitoring committees in paediatric trials will help create awareness among parents of the risks involved and the mechanisms that will be adopted to safeguard the children taking part in the trial.
Dr Sammons said: “We are calling for all paediatric drug trials to include independent safety monitoring committees to ensure that this vital work is carried out in a way that minimises risks, and maximises benefits, for the children taking part.”