Successful development of medicinal products for children always relies on the commitment of parents and children. The significance of the data obtained primarily depends on the study design.
Double-blind: Neither the patients and their families nor the medical team know whether a patient receives standard treatment or the investigational agent. Medicinal products are provided in a controlled manner, in neutral packages and comparable preparations. This helps to avoid distorted expectations regarding the results.
Actively controlled: The patients, their families and the medical team are informed about the patients’ allocation to the respective treatment arms. In this case, the new investigational agent is examined with reference to the standard medication, so as to be able to compare the tolerability and effects of the two products.