Neonatal studies may frequently breach GCP

Inflicting unnecessary pain on newborn babies is hardly the stuff of responsible and ethical trial design – and yet, this is exactly what a large number of studies apparently do.


According to a new review of medical literature, where effective pain relief is available, approaching two-thirds of studies that involve painful procedures are designed to include a group that receives no pain relief.


If this isn’t sadism – then what?


It is much simpler to show that a new intervention is better than nothing at all, than to carry out a true comparative trial. Also, because it is common in many countries for infants undergo minor procedures without pain relief, this may need to be reflected in the trial design.


But there is a serious risk that the pain to which babies are subjected is underestimated, because of their developmental stage. Research suggests that babies experience pain more powerfully than adults.


When a baby shrieks after an injection, it isn’t just at the betrayal of a trusted adult, it can be that the pain is far more intense that you would expect. This is partly because nerve pathways that help block painful sensations are not yet fully developed, and the receptive fields of nerve cells processing sensory input are larger.


Some studies suggest that injections can cause “severe” pain in babies, ranging from 5.4 to 6.4 on the Neonatal Infant Pain Scale, where 0 is no pain and 7 is maximum pain.


Apart from the clear ethical issues, withholding pain relief seems like a clear breach of the declaration of Helsinki and the Good Clinical Practice rules that stemmed from it.


Except in cases where “for compelling and scientifically sound methodological reasons the use of placebo is necessary,” the Declaration of Helsinki requires researchers to use the “best current proven intervention” in the control group.


For more information on this, read the Reuters article [here] 


Infonetica will be attending this year’s PRIM&R Advancing Ethics Research (AER) Conference in Boston next month. To book a one-to-one session with our product expert or for more details, [click here]





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