Studies have shown that over 50% of the medicinal products used in children may not have been tested or authorised for use in this age group. This leaves health care professionals with no alternative but to use medicines "off-label", judging the suitability and the correct dose of these medicines themselves in the absence of paediatric labeling information. This poses significant risks of inefficacy and/or adverse reactions for children.
The EU regulation (EC No. 1901/2006 on Medicinal Products for Paediatric Use) came into effect in January 2007 to ensure that medicinal products that are researched, developed and authorised in Europe will also meet the therapeutic needs of children. This will mean an increased demand for children to participate in clinical trials of new medicines.
The European research project RESPECT, led by the Institute of Clinical Sciences at the Sahlgrenska Academy at Gothenburg University, Sweden, set out to identify the needs and motivations of children and their families who have participated or might participate in clinical trials in Europe.
We explored the issues raised by children's participation in medical research by speaking with paediatric patients and their parents, patient support organisations, paediatricians, ethical committees and representatives of the pharmaceutical industry to gather their experience, insights and suggestions. This enabled us to make recommendations for how to empower children such that medical researchers respect their interests and can motivate their participation in future clinical trials.
Please see the Public documents tab for our presentations and articles, and the RESPECT book.
Address for correspondence John Chaplin PhD, RESPECT project