EMA questionnaire for children on the use of medicines and clinical trials
Measures at EU level
The European Medicines Agency (EMA) would like to increase the acceptance of participation of children and adolescents in clinical trials. To this end, a questionnaire has been designed that is aimed at children and adolescents between the ages of 10 and 18. It contains 11 questions and is divided into two parts. The first part asks which drugs children and adolescents are taking. The second part asks questions about participation in a clinical trial. In this way, the EMA wants to find out how consent and assent forms for clinical trials can be made more comprehensible. In this way, more children and young people should be encouraged to participate in such studies. The survey is related to the implementation of the so-called Children's Medicines Regulation (Regulation (EU) No. 1901/2006). It states that pharmaceutical entrepreneurs who submit an application for approval of a new drug must also offer it to children and adolescents in the correct dosage and dosage form. For this purpose, it is necessary that these age groups are also represented in the clinical studies. This is because many drugs used in children have not yet been adequately tested in children and are therefore not approved for children. Therefore, sometimes the appropriate - that is, effective and safe - dosage is not known. In addition, there is often a lack of dosage forms suitable for children. Nevertheless, pediatricians are often relied upon to use medicines that have actually only been adequately tested in adults in children. More information on the use of medicines in children can make drug therapy more effective and safer for these young patients as well.
Situation in Austria
AGES Medical Market Surveillance strongly supports the EMA's action and offers the possibility to answer the questionnaire electronically. It can be sent directly to the EMA by mail or e-mail. The survey will run until July 31, 2015, and the addresses are: Dr Franca Ligas Paediatric Medicines Office, European Medicines Agency 30 Churchill Place London E14 5EU, United Kingdom or to: children@ema.europa.eu
The questionnaire can be found here:
Children's Questionnaire_EMA Survey
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: 050555/25000
E-mail: presse@ages.at
