Information for families and patients regarding Hospital Sant Joan de Déu

What is a clinical trial?

A clinical trial is a clinical study in which an investigation is conducted on the effect of a medicine or a treatment on people, who are, in the case of our hospital mostly children. Medicines are substances with properties for the treatment and prevention of diseases and disorders.

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In a clinical trial, two treatments are usually compared: the medicine under study and a known treatment (for the disease) or an inactive substance called a placebo. The designation of which patients receive one treatment or another is usually determined by a random process as a random drawing, which is to say that neither the parents nor the children nor the researchers themselves choose the treatment group.

In order to obtain authorization for a medicine and to be used on a person, it must be put through this type of investigation (first), which is the most rigorous and reliable method to verify the dose, effectiveness, safety and side effects of a treatment.

 

Why are clinical trials necessary on children?

Children are not little adults.

Most medicines and treatments in pediatrics have not been previously tested on children and consequently it is difficult to know what the correct dosage is, what their safety features are and what their side effects may be. Moreover, children grow and change quite quickly and for this reason it is necessary to consider various growth stages when the treatment dosage is going to be studied: an 8-month-old boy is completely different from an 8-year-old boy, who is in turn completely different from an 18-year-old youngster/teenager/young adult. Each growth phase requires a different dossages of the medicine, different device sizes or a different treatment.

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Source: NIH, USA.

Clinical trials are important because they can help:

  • To understand the differences in children as they grow up and develop.
  • To identify the best dose without side effects.
  • To manufacture medicines that children can easily take (syrups, chewing-gum, etc...).
  • To discover/develope treatments for disorders that only occur/happen in children.
  • To discover/develope treatments for disorders that also happen in adults, but they progress differently in children.
  • To discover treatments that help to improve children’s quality of life.

For this reason the European Union Health Authorities (EMA) have made the decision to increase the number of clinical trials on children in controlled and regulated environments.

Vídeos

Explicando a niños los ensayos clínicos from Fundació Sant Joan de Déu on Vimeo.

Los ensayos clínicos en primera persona from Fundació Sant Joan de Déu on Vimeo.