Newborn infants should be allowed, with their parents' consent, to take part in multiple clinical studies unless there is evidence that this would undermine the biological or scientific validity of that research or compromise the care, safety, or legal rights of an individual infant or impose an unacceptable burden on the parents. These are among the conclusions of authors of a Viewpoint in this week's edition of The Lancet, authored by Dr Kathryn Beardsall, University of Cambridge Department of Paediatrics, Addenbrokes Hospital NHS Trust, UK and colleagues.
The authors say: "Although there may be ethical concerns about clinical trials in newborn infants because they are vulnerable and unable to consent for themselves, this has to be balanced by the concerns about the use of interventions in patients in whom they have not been tested. Most drugs prescribed to newborn infants have not been fully assessed in this age group…An increase in research involving children, including neonates, will clearly be needed."
The Viewpoint discusses the complications that can arise when infants are enrolled in more than one study, including the legal ramifications when problems arise, and how different drugs could interact with one another. The authors say: "Outcomes may be changed compared with when a drug is used on its own, which is of particular relevance if, as in many neonatal trials, the outcomes being measured are the same, for example survival."
But they conclude: "We advocate that infants should be eligible for recruitment to multiple studies unless there is evidence that this would undermine the biological and scientific validity of that research or compromise the care, safety, or legal rights of an individual. The current situation in which individual ethics committees, perhaps without any perinatal expertise, can give opinions on exclusion from other unknown studies is not helpful.
"We suggest a central advisory panel with appropriate expertise, possibly under the remit of the National Research Ethics Service or Medicines for Children Research Network in the UK, which could provide independent guidance on the need to exclude infants from recruitment to parallel studies. A positive decision for inclusion or exclusion in research should be part of the routine care of infants receiving intensive care. Hopefully in this way the evidence base for the medical care of newborn infants can be strengthened."
Dr Kathryn Beardsall, University of Cambridge Department of Paediatrics, Addenbrokes Hospital NHS Trust, UK T) +44 (0)1223 217677 / +44 (0) 1223 763404 E) kb274@cam.ac.uk
Journal
The Lancet