Recent US legislation has sought to increase the number of paediatric clinical trials. The aim is partly to increase the number of medicine proven to be effective against primarily childhood ailments. Equally important, it is to reduce the number of drugs prescribed to children without ever having been tested on them – after all, children are not just small adults!
I can only imagine the mental turmoil parents must go through deciding to enrol their children on a trial. Perhaps they are seeking a cure for the child’s illness that would otherwise be out of reach. Some are no doubt hoping that their child’s participation will help others.
A new report in the Journal of Pediatrics is bad news for parents as it claims that many paediatric trials are abandoned and go unpublished.
Good Clinical Practice rules make it clear that the risk to patients must be carefully managed and kept to a minimum – but some risk is usually inevitable.
So why are these trials abandoned?
Recruitment is tough in many trials – especially where the target group is children so some paediatric trials never really get off the ground.
The study examined 559 randomized, controlled paediatric trials from 2008 to 2010. Nineteen percent of these trials were discontinued early.
Funding issues were the least likely to be cited as reasons for trial discontinuation. But when it was an issue, academic-funded trials seemed more vulnerable than those sponsored by industry. Interestingly, the study found that industry-funded trials were 2 or 3 times less likely to be published that academically-funded ones.
Even when the trials were completed, 30% had not published any findings in scientific journals five years after then finished.
I have written before about the importance of reporting trials results – even negative ones. Far from being a waste of time, negative or inconclusive results can provide a valuable steer, informing future trials and avoiding costly blind-alleys.
This is true for all trials but, as a Father of three young children, I find it particularly hard to accept in the case of paediatric trials.
Read more [here]
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