Just 2% of child drug trials included independent safety checks says review of over 700 studies

Only two per cent of paediatric drug trials reported that they had established independent safety monitoring committees that can help lead to the early detection of adverse drug reactions, according to a major review in the April issue of Acta Paediatrica.

Child health researchers from the University of Nottingham, UK, carried out a detailed analysis of 739 international drug trials published between 1996 and 2002 to see what safety measures were in place and to monitor the levels of adverse drug reactions.

Just under three-quarters of the trials (74 per cent) described how safety monitoring was performed during the study, but only 13 studies (two per cent) had independent safety monitoring committees.

“We were very surprised by the low level of trials that had independent safety monitoring committees and are urging pharmaceutical companies to include these in all future trials involving children” says lead author Dr Helen Sammons, Associate Professor of Child Health.

“It is essential that appropriate drugs are developed for use in children and clinical trials need to continue. They are vital because they increase the chance of picking up adverse reactions before drugs are introduced into general clinical practice.”

Dr Sammons and her colleagues found that:

• Seven out of ten trials reported adverse events and a fifth of the trials reported a serious adverse event (an untoward medical occurrence, not necessarily related to a drug).
  
  
• Adverse drug reactions were reported in just under 37 per cent of trials, with 11 per cent of trials reporting moderate or severe adverse drug reactions.
  
  
• Six clinical trials – which all had safety monitoring committees – were terminated early because of significant drug toxicity.
  
  
• Deaths were reported in 11 per cent of the trials, but the majority were thought to be unrelated to the drug use.
  
  
• Death rates were highest in trials involving premature babies, with 56 per cent of the 99 trials included reporting a death.
  
  
• Other major specialities in which deaths were reported included infectious diseases, neurology, respiratory and kidney problems.