GRS Blog

European and Non-European Paediatric Clinical Trials (peer reviewed article)

15/5/2011

Pharmaceutical companies are increasingly conducting clinical trials – including paediatric trials – in non-European countries.  

In much of Europe and the US, paediatric trials are associated with severe recruitment problems. Paradoxically, significantly large potential paediatric trial populations exist in Russia, Ukraine and the CIS countries, making these regions particularly attractive in terms of accommodating the forthcoming expansion of paediatric trials. 

Ethics committees within the CIS countries are keen to address issues relating to the conduct of paediatric trials, and are constantly working on and revising their policies on paediatric studies. 

The article outlines the advantages of conducting paediatric trials in non-European countries and the regulations involved, as well as examining the requirements of paediatric investigation plans, ethics committees and competent authorities, local insurance, import and export licences and other documentation required both in the EU and in selected non-European regions.

Author: Greer Deal, Director of Global Regulatory Services.