INTERNATIONAL STANDARDS FOR
CONDUCTING PEDIATRIC CLINICAL TRIALS
Philip D. Walson
Division of Clinical Pharmacology and
Clinical Trials Office, Children's Hospital Medical Center, Cincinnati,
Ohio, USA
Until recently the number of
medications that had been adequately studied in children was extremely
limited. Only 20% in the medications available in the United States (US)
had adequate studies done in children. New drug development regulations and
legislation have changed this. There has been a tremendous increase in
paediatric drug trials done in the US and abroad. This increase as well at
ethnic differences in human pharmacology require paediatric studies to be
done on a global basis. In response, members of industry, the US Food and
Drug Administration (FDA), the European Community (EC), and Japan have
developed the International Congress on Harmonization (ICH) paediatric
guidelines to encourage and facilitate timely, high quality, ethically
acceptable pediatric medicinal product development. These ICH guidelines
provide a framework for the international standardization of paediatric
drug trials. Investigators in any country that participates, or plans to
participate in paediatric drug development understand and apply the
principles listed in these guidelines.
The ICH Guidance on Clinical
Investigation of Medicinal Products in the Paediatric Population (ICH E11)
will be reviewed and their implications for global drug development
discussed.