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Why isn’t there more research on children’s medicines?

A new network project will ensure that children’s medicines are tested at the same rate as medicines for adults. Estelle Naumburg is an associate professor and paediatric cardiologist hired by Karolinska Institutet for the project Connect4Children.

How much research is done on children’s medicines today?

Photo of Estelle Naumburg.
Estelle Naumburg. Photo: Oskar Omne.

“Surprisingly little. About half of the drugs used in an average children’s ward has gone through a clinical trial where the drug’s effect on children has been assessed.  Only 10 per cent of the medicines used on the neonatal ward have been tested in studies on children Paediatricians are often forced to treat children based on their own experience, but children are very different from adults. Their bodies metabolise drugs differently and we often know too little about the potential long-term side effects. There is also large difference between children; a two-year-old has a completely different metabolism than a twelve-year-old.” 

Why are there so few studies carried out on medicines for children?

“There are several reasons.  Thankfully, most children are healthy and do not suffer endemic diseases the same way adults do.  That can make it difficult to find enough patients to carry out research on, especially if there is no collaboration between researchers, doctors, and authorities in different countries.  Fewer patients also means it is more difficult for pharmaceutical companies to recoup the cost of research and development”.

What is the situation in Sweden?

“Sweden is far behind where networking is concerned, compared to other Nordic and several European countries. Currently there are only two of us at Karolinska Institutet’s Department of Laboratory Medicine with the task of developing a national network with international collaborations: Anders Rane, the senior professor, and I. It is unsustainable.  What we need is a national group of administrative experts for clinical trials involving children. Everybody thinks it is important, yet no one is willing to finance it.”

What is this project meant to do?

“The EU project C4C was initiated in 2018 working to build a European network of experts. When a pharmaceutical company or a doctor is commencing a clinical study, they contact us. Each country checks which paediatric patients are in their network and within days we will be able to say how many patients each country is able to contribute with and if we are able to participate. It provides a critical mass which was previously unavailable yet so very important to drug trials.”

What studies have already commenced?

“Four studies are underway and another three or four will be initiated this autumn. Amongst them are studies on how paracetamol may be used to close a fetal connection in the heart of preterm infants, and if steroids can supplement the treatment of Kawasaki’s disease, a disease which only occurs in children, causing inflammation in blood vessels. What is special about these studies is that they really reflect children’s needs and children’s diseases.  Too much pharmaceutical research is carried out based on the needs of adults, and children are only marginally considered.

Text: Anna Molin, first published in Swedish in the magazine Medicinsk Vetenskap No. 1, 2020.