Why perform clinical trials in children?

WHO gives a good explanation for our activities: “Children are a unique population with distinct developmental and physiological differences from adults. Clinical trials in children are essential to develop age-specific, empirically-verified therapies and interventions to determine and improve the best medical treatment available” (cited from WHO International Clinical Trials Registry Platform (ICTRP).

A great number of activities has been initiated worldwide to improve the medicinal knowledge about children with serious diseases. But also banal illnesses and not life-threatening diseases are still commonly treated by the paediatrician with off-label use medications that have been tested only in adults. From the common cold to non-problematic children’s diseases and allergies, the situation is still often unsatisfactory.

Experience matters

Our experience covers phase-III clinical trials and phase-IV-/non-interventional studies with children in OTC medications and non-life-threatening diseases. A network of enthusiastic resident paediatricians ensures excellent recruitment rates.

Informed Consent Procedure

A tricky question in clinical trials with children: How to involve the legal representative(s) of the minor? How to inform a child adequately depending on age and level of mental development? When to use pictograms and smileys? How to involve child psychologists?

Our knowledge and experience is helpful in all these questions.

 

 

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