European Commission publishes guidelines on paediatric clinical trials

The European Commission and the European Medicines Agency (EMEA) have published guidelines for paediatric clinical trials.

The 'Commission guideline' is intended to go along with the future European regulation aimed at favouring the development of paediatric medicines. Adopted by the European Parliament in May, this draft regulation must now receive the endorsement of the EU Member States before the end of the year for entry into force in 2007.

'The protection against the risks of research in such a vulnerable population is paramount whilst this should not lead to denying them the benefits of research,' the document states.

Emphasising the fact that children 'are not small adults', these recommendations, which concern the participation in clinical trials of children and adolescents up to 18 years, propose the application of ethical principles as they are understood currently.

The authors of the document note that the parent/s or the legal representative can give informed consent on behalf of the child, the latter not being able to provide legally binding consent. For adolescents aged between 16 and 18 years, if they are no longer considered as minors or if they are independent, informed consent of the adolescent is then required.

The parents or legal representatives must have time to reflect and have the information necessary to make the decision. No financial incentive must be offered to them (apart from compensation for expenses and the time spent on the trial).

For families originating from other countries, an independent mediator for the sponsor and the trial investigator who is familiar with the language and cultural traditions of this family, will assist in the process of obtaining consent.

In the case of emergency trials, informed consent from the parent/s or legal representative must be obtained retrospectively and as quickly as possible. The child's assent is also taken into account, in addition to the consent of the responsible adult.

As far as ethics committees are concerned, the recommendations, which are within the framework of the European Directive on clinical trials, says that committees supervising a paediatric trial must benefit from expertise in paediatrics, either from within the committee or from external experts by means of ad hoc consultation.

Among the other subjects addressed, the document mentions the issue of setting up placebo groups, which must be more restricted in trials with children.