A national network for paediatric clinical research has been launched in Belgium by a coalition of the Belgian Paediatric Society, the federal medicines agency, AFMPS, and the pharmaceutical industry association, pharma.be.
The industry association expects to put €100,000 into the launch of the network and its first two years of operation. The initiative is aimed at improving significantly the quality, efficacy and safety of medicines for children, who are “not little adults”, pharma.be emphasised.
It should do this by co-ordinating and encouraging clinical trials in Belgium research centres, which requires knowledge-sharing between paediatricians, pharmaceutical companies and contract research organisations (CROs) to overcome the acknowledged difficulties that can arise in finding young patients for studies. At the same time, pharma.be noted, the network should make paediatric medicines available to patients as quickly as possible.
The European Union’s regulation on medicinal products for paediatric use (No. 1901/2006) made it vital that a national paediatric clinical research network should be established in Belgium along the lines of networks already created in Germany, France and the Netherlands, pharma.be said.
Belgium already had a committee of experts in this area, including paediatricians active in clinical research as well as hospital pharmacists and representatives of ethics committees, the pharmaceutical industry and CROs. This was formed on the initiative of AFMPS, Professor Daniel Brasseur, president of the European Medicines Agency’s Paediatric Committee, and Professor Doctor José Ramet, president of the Belgian Paediatric Society.
Ramet will serve as co-ordinator of the Belgian paediatric clinical research network. AFMPS will also play a fundamental role, by following closely the associated scientific advances and quality standards, pharma.be noted.
At the beginning of January, it pointed out, a group of Belgium MPs introduced a motion for a resolution on medicines for children. It called, among other things, for better structured and co-ordinated research and development on paediatric medicines in Belgium and for more resources to meet the goals of the European regulation. These objectives are, naturally, at the forefront of the new Belgian research network, pharma.be commented.
