Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Implications of the EU Clinical Trial Directive 2001/20/EC on the conduct of paediatric studies in Germany

Lada Bogdanovic (Abschlußjahr: 2004)

This master thesis is intended to provide background to the European Union (EU) Directive on clinical trials "Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use" which was adopted in April 2001. The implementation into national law should have come into force in each EU member state by 1 May 2004.

This directive takes into account some specific concerns of performing clinical trials in children, and in particular lays down criteria for their protection in clinical trials. It states that clinical trials in minors may only be undertaken if informed consent of the parents has been obtained. The consent must represent the minor's presumed will and no financial inducements except compensation may be offered. The child's assent after information from staff with experience with minors has to be obtained as well. The clinical trial no longer has to be of direct benefit to the participating child but to the group of patients. Clinical trials have to be designed to minimise pain, discomfort, fear and any other foreseeable risks in relation to the disease and development stage of the child, as well as the responsible ethics committee is required to have specific expertise in the field of paediatrics.

Drug development and labelling for children is considered as insufficient, but currently there is no legal provision for obliging these studies to be performed if the company does not present the product for use in the paediatric population. Clinical trials in children were largely avoided because of the general vulnerability of children and their inability to provide fully informed consent. Paediatricians and general practitioners are often in the position of having to adapt medicines studied exclusively in adults for use in their child patients.

The directive refers to the conduct of clinical trials, not to licensing requirements. With a new proposed European regulation relating to "Medicinal Product for Paediatric use", which is currently still in consultation stage, pharmaceutical companies will be required to provide paediatric data for all new marketing authorisation applications. The reward will be a (six-months) extension of the supplementary protection certificate.

It remains to be seen if in the light of these additional developments in the EU, the EU Directive can encourage more paediatric studies in Germany.

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