New recommendations on ethical aspects of clinical trials in children

On 4 April 2005, the European Parliament and the Council launched the Directive 2001/20/EC related to good clinical practice in the conduct of clinical trials on medicinal products for human use.

The ad hoc group for the development of implementing guidelines for this Directive has drawn up new recommendations on various ethical aspects of clinical trials performed on children, with the European Medicines Agency acting as rapporteur. These recommendations will contribute to the protection of children in clinical trials, and will facilitate the harmonisation of conducting such trials in the EU.

The recommendations address various ethical aspects of clinical trials performed in children such as:

 Specific protection should be defined for research on children
 Recognition of the need to carry out specific trials that cannot be performed on adults.
 Children’s assent should be sought using age appropriate information.
 Ethics Committees need paediatric expertise to balance the benefits and risks of research in children.
 Investigators with paediatric experience should perform the design, analysis and the choice of comparators used in trials.
 Pain, fear, distress and parental separation should be prevented and minimised when unavoidable, especially in the most vulnerable age groups.

For further information

 Directive 2001/20/EC
 Recommendations to contribute to the protection of children in clinical trials
 European Medicines Agency
 EMEA workshop on modelling in paediatric medicines. April 2008. London

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