What is a clinical trial?
A clinical trial is a study which investigates the effects of a medicinal product or treatment on people.
In the case of the SJD Barcelona Children's Hospital, we focus our trials on children and adolescents.
In order for a medical product to be authorised and used on people, it must be subjected to clinical trials, which is the most rigorous and reliable way of ascertaining the quantity, efficacy, safety and side effects of drugs.
What does a clinical trial entail?
Normally, in a clinical trial, two treatments or drugs are compared - the one under study and another already known drug, or an inactive substance, also known as placebo. Neither the parents and children nor the investigators themselves know which treatment the patient receives, to avoid skewed results. There is usually an anonymous draw to assign the treatment to the patient.
Why is it important to conduct clinical trials on children and adolescents?
Children are not simply small adults, drugs and treatments may have different effects than on grown-ups. The majority of treatments administered to paediatric patients have not previously been tested on children, owing to which, it can be difficult to determine the correct dose, the safety thereof, or the side effects that may appear.
Moreover, children grow and change very quickly, which means that the doses and administration guidelines for medicines change in each stage of the patient growth (from 0 to 18 years of age).
For this reason the European Union health authorities resolved to allow an increase in paediatric clinical trials in a regulated setting.
How can clinical trials help? What practical application do they have?
Clinical trials are important because they help researchers and doctors to find new treatments:
- For illnesses which only occur in childhood and adolescence.
- For illnesses which also appear in adults but which manifest themselves differently in children.
- Which help to improve children's quality of life
Clinical trials can also help us to understand the differences caused by growth and development in children, and thus to be more precise when calculating the dose of the drug to be administered to patients in each stage of growth, without giving rise to side effects. Finally, they enable us to create drugs which children can take easily, in different formats (chewing gum, syrups, etc.).
Who ensures the safety of clinical trials?
At the Sant Joan de Déu, clinical trials are reviewed and approved by the Sant Joan de Déu Foundation's Independent Ethics Committee and the Spanish Agency of Medicines and Medical Devices (AEMPS).
Additionally, we apply all the legal procedures and control systems stipulated by Spanish legislation for clinical trials on medical products for human use.
Can my child participate in a clinical trial at the Sant Joan de Déu?
In a clinical trial at our centre, all those children who meet the requirements of the clinical study to be conducted, whether they are patients of the hospital or not, may participate. We refer to age, weight, gender, illness under study, treatments they are currently receiving, and any other which may be specified.
The patient's referring physician can help to determine whether your child may be a candidate for participation in one of our trials. Participation in a clinical trial will always be conducted voluntarily and altruistically.