1 00:00:03,000 --> 00:00:07,880 It took quite long to get legislation to force companies to study drugs in children... 2 00:00:08,000 --> 00:00:10,400 because before that time we thought... 3 00:00:10,520 --> 00:00:14,520 that just adjusting the dose for children based on the adult dose would be enough. 4 00:00:14,640 --> 00:00:18,120 But because incidents occurred and children were actually harmed... 5 00:00:18,240 --> 00:00:21,120 or children did not actually get effective therapy... 6 00:00:21,240 --> 00:00:24,280 we started to realise that this was not the right approach. 7 00:00:24,400 --> 00:00:28,280 Then it took quite a bit of time, I think, to also lobby governments... 8 00:00:28,400 --> 00:00:33,040 that they had to put a legislation in place to force companies to study drugs in children. 9 00:00:34,040 --> 00:00:37,080 There is a difference between drugs in children and in adults. 10 00:00:37,200 --> 00:00:40,720 When you give a drug to a child, the way it goes through the body is different. 11 00:00:40,840 --> 00:00:44,520 Absorption may be different, drug metabolism in the liver may be different... 12 00:00:44,640 --> 00:00:50,280 and excretion, for example, in the kidneys. Also, the biology of the child is different. 13 00:00:50,400 --> 00:00:55,360 So side effects may also be different, because of this change in biology. 14 00:00:55,480 --> 00:01:00,400 Even today, when I work in a paediatric intensive care unit I prescribe drugs to children... 15 00:01:00,520 --> 00:01:04,200 of which I do not know if they are actually effective in that specific child... 16 00:01:04,320 --> 00:01:06,720 or if they will be safe in that child. 17 00:01:07,720 --> 00:01:10,800 My interest in this topic came when I started my PhD... 18 00:01:10,920 --> 00:01:15,680 where I started to do research to understand how children's bodies are different. 19 00:01:15,800 --> 00:01:19,840 Through this work I became the director of the paediatric Dutch formulary. 20 00:01:19,960 --> 00:01:24,040 Through my research and this work I also got involved in European initiatives... 21 00:01:24,160 --> 00:01:28,640 to improve our infrastructure on how to perform drug studies in children. 22 00:01:28,760 --> 00:01:33,120 Like the recent project we got funding for, connect4children. 23 00:01:34,120 --> 00:01:40,480 The key goal of connect4children is that in 5.5 years we will have a European-wide network... 24 00:01:40,600 --> 00:01:45,560 that is able to perform effectively and fast clinical trials in children... 25 00:01:45,680 --> 00:01:48,680 that have been designed in a way that they are as child-friendly... 26 00:01:48,800 --> 00:01:52,360 and as professionally optimal as possible. 27 00:01:54,360 --> 00:02:00,880 These initiatives are already generating results. The c4c project in itself will provide results. 28 00:02:01,000 --> 00:02:04,960 The goal is that in 5.5 years we will have an infrastructure in Europe... 29 00:02:05,080 --> 00:02:09,520 that's able to help design and conduct clinical trials in children. 30 00:02:09,640 --> 00:02:16,640 I myself see it more as a changing continuum where we improve almost every single day. 31 00:02:17,640 --> 00:02:20,640 I think this is the next step in this process... 32 00:02:20,760 --> 00:02:25,520 that will really help us to get children to receive effective and safe medicines. 33 00:02:26,520 --> 00:02:32,360 I would be extremely excited if I could go to my PICU, speak with parents and tell them... 34 00:02:32,480 --> 00:02:36,920 that the drugs that we will be giving will be working in their child and that they will be safe. 35 00:02:37,040 --> 00:02:40,480 That they can look them in the eye and be absolutely sure about this.