It took quite long to get legislation to force companies to study drugs in children...
because before that time we thought...
that just adjusting the dose for children based on the adult dose would be enough.
But because incidents occurred and children were actually harmed...
or children did not actually get effective therapy...
we started to realise that this was not the right approach.
Then it took quite a bit of time, I think, to also lobby governments...
that they had to put a legislation in place to force companies to study drugs in children.
There is a difference between drugs in children and in adults.
When you give a drug to a child, the way it goes through the body is different.
Absorption may be different, drug metabolism in the liver may be different...
and excretion, for example, in the kidneys. Also, the biology of the child is different.
So side effects may also be different, because of this change in biology.
Even today, when I work in a paediatric intensive care unit I prescribe drugs to children...
of which I do not know if they are actually effective in that specific child...
or if they will be safe in that child.
My interest in this topic came when I started my PhD...
where I started to do research to understand how children's bodies are different.
Through this work I became the director of the paediatric Dutch formulary.
Through my research and this work I also got involved in European initiatives...
to improve our infrastructure on how to perform drug studies in children.
Like the recent project we got funding for, connect4children.
The key goal of connect4children is that in 5.5 years we will have a European-wide network...
that is able to perform effectively and fast clinical trials in children...
that have been designed in a way that they are as child-friendly...
and as professionally optimal as possible.
These initiatives are already generating results. The c4c project in itself will provide results.
The goal is that in 5.5 years we will have an infrastructure in Europe...
that's able to help design and conduct clinical trials in children.
I myself see it more as a changing continuum where we improve almost every single day.
I think this is the next step in this process...
that will really help us to get children to receive effective and safe medicines.
I would be extremely excited if I could go to my PICU, speak with parents and tell them...
that the drugs that we will be giving will be working in their child and that they will be safe.
That they can look them in the eye and be absolutely sure about this.