International expert group publishes recommendations on children’s medicine development

A major group of international experts and patients have defined new parameters for the development of medicines to treat children and young people.

Their recommendations on how the processes should be improved have been published in The Lancet Psychiatry.

The group identified a range of issues which need to be addressed, including:

• A greater focus on disorders for which no evidence-based or no well-studied pharmacological interventions are available
• Taking an overview of other important outcomes, not just the core symptoms tested in trials
• Adapting the approval process so that that effective medicines for children can be approved more efficiently
• A better understanding of long term effects on the developing brain (both beneficial and harmful)

The authors of the article suggest that in some cases it may be worth rereviewing medicines which were approved under less rigorous conditions, and that this may have to come from public funds.

The work was led by a group of experts from the Child and Adolescent Network of the European College of Neuropsychopharmacology (ECNP), alongside representatives from the European Medicine Agency (EMA) and families of patients with lived experience of mental problems in children and young people.

Professor Samuele Cortese of the University of Southampton, first author of the study, said: ‘We believe this is the first expert-patient initiative of its kind. As members of the ECNP, Child and Adolescent Network, we were privileged to work not only with colleagues from the EMA, but also with representatives of associations of people with lived experience, who provided extremely valuable insights. Research in this field can advance only via joint efforts from doctors, researchers, regulators, and people with lived experience.

‘We identified new ways of designing studies, and these need to be part of treatment research in child and adolescent psychopharmacology, to produce more effective and safer treatments.

‘In addition, there are concerns around short and long term effects of medications. We need to use these new study designs also to understand when it is better to use non-pharmacological treatments. The project surveyed families with children affected by mental health problems and found that most of them wanted priority given to more effectively communicating the risks and benefits of medicines. Patients need to be involved more consistently in research than they are at present.’

Image: Kevin Gent

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