Under the regulation, a paediatric investigation plan, or PIP, must accompany all new product approval applications in the EU from July 26, 2008. The same applies to applications for new indications from January 26, 2009. PIPs describe the paediatric trials a company intends to conduct with its product.
The recommendations, developed by the commission’s ad hoc group help ensure all children involved in clinical studies are protected against the risks of research while allowing them to benefit from such research. The guidelines also address the responsibilities of all those involved at any stage of a trial, including sponsors, ethics committees, regulatory bodies, pharmaceutical companies, insurance firms, investigators, families and patient representatives. It is also relevant to trials conducted outside the EU, especially developing countries, and can also be used for non-interventional trials.
In conducting paediatric trials, investigators usually face problems in obtaining legally binding informed consent from minors. In such cases, consent should be sought from the parent or legal representatives without any undue pressure on the child. In order to avoid unnecessary replication of trials, the paediatric regulation includes a derogation from the clinical trials directive, stating that the descriptions of trials and their results are to be made public. Ethics committees were urged to reject paediatric protocols that prevent independent publication by investigators.