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Clinical Research: information for families on clinical trials

The SJD Barcelona Children's Hospital is the leading state centre in paediatric clinical trials, thanks to the cooperation of patients and families. Clinical trials with treatments and drugs are essential for us to be sure of their efficacy and suitability for paediatric use.

Children and adolescents are indispensable in research into their health and can make an active contribution to major advances. Moreover, thanks to clinical trials, sick children can benefit from a treatment option that hitherto did not exist.

Why participate in a clinical trial?

Participation in a clinical trial

Participating in a clinical trial is conditioned upon the patients and their families having all the information they need to take important decisions. Find out more about what clinical trials are, how they are performed, how to participate and other relevant info.

About clinical trials

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 which 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 SJD Barcelona Children's Hospital, clinical trials are reviewed and approved by the San Juan de Dios 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.

Participating in a clinical trial at the SJD Barcelona Children's Hospital

Can my child participate in a clinical trial at the SJD Barcelona Children's Hospital?

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.

What benefits or risks may arise in a clinical trial?

When conducting a clinical trial, it is hoped that the treatment under study will provide benefits, such as being more effective than other treatments, or even that it may cure an illness. Nonetheless, it cannot be guaranteed that the child will receive the study drug, since there is normally a random selection process by means of which each patient is assigned either the drug under study, another already known one, or an inactive substance (placebo), making it possible to obtain valid, reliable results.

There is also the possibility of your child suffering from side effects from the administration of the treatment under study, even though clinical trials are specially designed to ensure the minimum possible risk for participating patients.

What tests and procedures may be performed on my child?

The first is ascertain whether your child is eligible to participate in a specific clinical trial, depending in the inclusion and exclusion criteria that have been defined (age, weight, current medication, etc.). If your child is eligible, the doctor will give you all the information on how the clinical trial is going to be conducted, and you will need to sign a document called an informed consent form, in which all the details of the procedures to be carried out during the study (which may include additional tests to those usually performed) will be explained.

What is an informed consent form?

It is a document which must be signed by the family and the child (if over 12 years of age) indicating your agreement to participate in a clinical trial. A number of different aspects are explained in the informed consent form: that your participation is voluntary, the reasons for conducting the clinical trial, which procedures are going to be performed and for how long, the possible risks and benefits of participating in the study and, finally, other treatments available.

What clinical trials are currently ongoing at the SJD Barcelona Children's Hospital?

The Hospital is currently participating in clinical trials in more than 30 research areas. You can find out more information on the San Juan de Dios Foundation's website.

What clinical trials are being conducted by the SJD Barcelona Children's Hospital?

Currently, the Hospital participates in clinical trials of more than 30 research areas. We invite you to consult those areas in the San Juan de Dios Foundation website.
 

Would you like to participate in one of our clinical trials?

If you would like to participate in any of the clinical trials conducted at the SJD Barcelona Children's Hospital or you have any queries, you can contact the Clinical Research Unit (Clinical Trials). Send us your message!

IMPORTANT: don’t forget to tell us, in the form’s Message field, your son or daughter’s diagnosis.

Clinical Research Unit

Joana Claverol Torres

SJD Barcelona Children's Hospital. Sant Joan de Déu, 2, Edificio Consultas Externas, 0ª planta. 08950 Esplugues de Llobregat (Barcelona)
+34 93 600 97 33
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