European Medicines Agency hosts workshop on ethics in paediatric clinical trials

News 02/12/2011

The European Medicines Agency has hosted a European workshop on ethical considerations for clinical trials carried out in children.

The workshop, which was held on 29 and 30 November 2011, set out to examine how ethics committees in European Union (EU) Member States could work together with the Agency's Paediatric Committee (PDCO) in an efficient manner when considering the ethical aspects of the design and conduct of trials.

The workshop, which was the first forum for direct dialogue between ethics committees and the PDCO, brought together 25 ethics-committee members, as well as more than 20 European regulators, members of paediatric research networks and clinical researchers, representatives from more than 40 pharmaceutical companies and experts in paediatric ethics from the United States of America and Canada. It included discussions on:

  • how ethics committees and the PDCO evaluate proposals for paediatric trials;
  • the methodology and the ethical aspects of clinical trials, allowing participants to share experience of the difficulties they encounter;
  • visions for the future, including opportunities for sharing of information, improving the quality of paediatric trials and protecting children who take part in trials.

The participants acknowledged the areas of shared interest between the PDCO, whose main responsibility is to evaluate the design of future trials to be carried out in children, and ethics committees, which are responsible for determining whether a particular study can go ahead on ethical grounds.

They also recognised the shared responsibilities of the European Network for Paediatric Research at the European Medicines Agency (Enpr-EMA), paediatric clinical researchers, pharmaceutical companies, the Agency, the PDCO, ethics committees and patients in improving the quality and ethical acceptability of paediatric trials and in increasing access of children to clinical research.

A report from the workshop, together with the slides from the presentations, will be published on this website soon.

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