(Vienna 14th May 2012) “Studies on children are needed since children are not small adults and can respond very differently to medications. Consequently, medications for children need to be tested on children. Parents and society have to recognize this,” says Christoph Male from the University Department of Paediatrics and Adolescent Medicine as part of the International Day of Clinical Research, which this year is being organised under the motto "Research for Child Health".
The reasoning behind this call is this: studies involving children, who are individuals requiring particular protection, have been generally regarded as unethical in the past. According to and in compliance with the Medicines Act (AMG), these types of study were almost impossible. Since 2004, however, the AMG has recognised the need for studies on children and permits them subject to particular protective measures. An EU Directive from 2006 stipulates that when a drug is licensed, testing on children is now mandatory. This will certainly improve paediatric medicine considerably over the next decade.
There is still, however, a considerable degree of uncertainty, particularly on the part of parents. Says Male: “Concerns about allowing a child to take part in a study are of course understandable, but there are certainly not founded. On the contrary: in studies that take account of the needs and safety of children, such children are very well protected. Better than with the everyday use of drugs that are not approved for use in children, in fact. Clinical studies represent the only way of making drugs that are suitable for children available.”
The younger the patient, the fewer medicines there are available
Between 50 and 90 per cent of medications used currently are not approved at all for children. To arrive at a suitable dose, clinicians extrapolate downwards the recommendations for adults. These medications are then – since there are no other options for certain necessary treatments – used outside their approved indications (“off label”), which represents an increased risk. “Not only can side effects occur that have never been observed before in adults, but there is also the risk of overdose or under-dosing,” says Male, who is also Head of the “Medicines in Childhood” working group within the Austrian Society for Paediatrics and Adolescent Medicine and who also represents Austrian paediatricians to the European Medicines Agency (EMA).
Even if parents are persuaded to allow their children to take part in a study, the hurdles are considerable and the outlay and effort involved are tremendous: studies can only be carried out on sick children and must incorporate all age groups, from new-borns to teenagers. Says Male: “In older children, the care is still extremely good. The younger the patients are and the more severe their illness, the fewer options for drug treatment there are.” This particularly highlights the need to involve very small children in studies. “Children and their parents need to realise that medicine studies are essential if treatments are to improve. They mostly bring benefits for the individuals involved – and important information for everyone else.”
The MedUni Vienna is taking part in multi-centre studies involving children and is part of a huge network aimed at gathering secure data for paediatric research. Often, there are not enough children in every age group with a condition for which a medication needs to be tested. “Consequently, study participants from a large number of centres are needed,” explains Male, who is also Head of the Anticoagulant Clinic in the Paediatric Department.
Service: International Day of Clinical Research 2012
The International Day of Clinical Research 2012 is being held from Friday, 18th May to Sunday, 20th May at the Campus of the old Vienna General Hospital (Courtyard 2, Spitalgasse 2, 1090 Vienna). In Vienna, the event is being organised by the MedUni Vienna's Coordination Centre for Clinical Studies (KKS). A full list of programme events can be found here: http://www.meduniwien.ac.at/hp/tdkf. On Saturday, visitors will be able to experience numerous hands-on activities, including some suitable for children, that will offer a glimpse behind the scenes of clinical research.