Ethical considerations for clinical trials on medicinal products conducted with the paediatric population: Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use

New recommendations have been published that are intended to contribute to the protection of children in clinical trials, while also facilitating and harmonising the conduct of such trials across the EU.

The recommendations were drawn up by the European Commission-led ‘Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC’, with the EMEA acting as rapporteur.