, Volume 65, Issue 8, pp 747-748
Date: 12 Jun 2009

Can we get the necessary clinical trials in children and avoid the unnecessary ones?

This is an excerpt from the content

Clinical trials are necessary to provide data on the safety, efficacy and optimal use of medicines. In children, data are needed to cover all ages, from newborns to adolescents. Getting the necessary clinical trials performed is required to achieve the goals of the U.S., EU and WHO paediatric medicines initiatives [1]. However, as stated in the EU Paediatric Regulation [2], unnecessary trials should be avoided for obvious ethical reasons.

For new medicinal products of therapeutic interest for children, the EU requirement of early submission of a Paediatric Investigation Plan (PIP) for approval by the Paediatric Committee (PDCO), and compliance with the PIP to get the substantial reward/incentive are likely to capture most of the necessary trials being [2] performed. So far the majority of the 122 PIPs approved by the PDCO [3] include a deferral for the studies to be performed after more data become available in adults. However, it is already evident that clinical trials of off-patent pr