Our aim is to facilitate the work of researchers, laboratories and companies who need to assess the efficacy of treatments and products.
Forming part of the Sant Joan de Déu Research Institute, and with over 74 researchers and a staff of 24 professionals, the Unit focuses on two aspects. On the one hand, we conduct tests on new medical devices to ensure their suitability for paediatric use, on the other hand, we conduct clinical trials to investigate the effects of a treatment of medicine in children and adolescents.
None of this would be possible without the collaboration of the children and their families, who place their trust in us to make progress in research into treatments which may result in the cure for illnesses or improve the quality of life for paediatric patients.
Why SJD Barcelona Children's Hospital?
We are the only paediatric unit in Spain that includes all the specialities and we are leaders at a state-wide level. This enables us to have a higher volume of patients and trials and therefore our results are very representative.
Since 2012 we have doubled the number of clinical trials in which we participate. We are currently involved in almost 150 trials in more than 30 research fields, which is a remarkable number in the paediatric setting.
We have a centralised coordination and management model of trials and studies, with both our own and external sponsors. This enables us to provide more effective advice in the conduct of non-commercial clinical trials and to facilitate a single point of contact to external trials sponsors thus centralising management.
Our team is composed of specialists in clinical research who are fully dedicated. We have facilities that are specially designed to accommodate patients and families who participate in clinical innovations and trials. This enables us to provide a more personal service throughout the process and to give you all the support you need.
The professionals at the Clinical Research Unit of the SJD Barcelona Children's Hospital accompany patients and their families through the entire clinical trial process, assessing them and resolving any questions that may arise.
Likewise, they advise the investigators and perform management activities required to conduct the trials (legal and regulatory procedures, sample extractions, administration of treatments and data entry), with a “single window” approach.
We have a multidisciplinary team of highly qualified professionals, trained in Good Clinical Practice.
- Joana Claverol Torres, Unit Coordinator.
- Alba Murciano, SJD Barcelona Children's Hospital Pharmacy.
- Joan Vinent, SJD Barcelona Children's Hospital Pharmacy.
- Marta Cubells, research nurse.
- Cristina Llanos, research nurse.
- Mari Molero, research nurse.
- Marta Sánchez, research nurse.
- Laura Solé, research nurse.
- Sandra López, research nurse.
- Ainhoa Andueza, project manager.
- Rosa Morales, financial management.
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.
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.
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.
Participation in 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.
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.
Regulatory agents linked to drug authorizations, as Food and Drug Administration (FDA) and European Medicines Agency (EMA), determine the design of clinical trials and, therefore, the use or non-use of placebo. In oncology or ultra-rare disease studies, it is common for placebo not to be used and for the study to be conducted directly on the drug.
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.
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.).
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
En un ensayo clínico de nuestro centro pueden participar todos aquellos niños y niñas, pacientes o no del Hospital, que cumplan los requisitos del estudio clínico que se quiere realizar. Estamos hablando de edad, peso, género, enfermedad a estudiar, tratamientos que recibe actualmente y cualquier otro que se especifique.
El médico de referencia del paciente puede ayudar a determinar si tu hijo o hija puede ser candidato a participar en uno de nuestros ensayos.
La participación en un ensayo clínico siempre se realiza de forma voluntaria y altruista.
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. Exceptions exist in clinical trials, for example, in some studies of cancer treatments or ultra-rare diseases.
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.
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.
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.
Currently, the Hospital participates in clinical trials of more than 30 research areas. We invite you to consult those areas in the Sant Joan de Déu Research Institute website.
Special treatments requiring health authorisation (compassionate use drugs)
A clinical trial is a research conducted on human subjects to test the safety and/or efficacy of a researchal medicinal product: a medicinal product that has not been marketed because it is being tested, or that is marketed but is being tested for a purpose other than that authorized.
Clinical trials are driven by a sponsor, which is a legal entity (company) responsible for conducting the study. This may be a pharmaceutical company or a research centre (such as the Sant Joan de Déu Research Foundation, for example). The sponsor submits a clinical trial protocol, which is the document approved by the ethics committee and the regulatory body which, in Spain, is the Spanish Agency for Medicines and Health Products (AGEMED) and, on the continent, the European Medicines Agency (EMA).
AGEMED and/or the EMA define the characteristics of the study participants and determine the inclusion and exclusion criteria in each case, as well as the characteristics of the experimental treatment (investigational drug) and the medical procedures to be performed on the patient to determine the efficacy and safety of the treatment.
To gain access to investigational treatments, the patient must meet the inclusion criteria that have been established in the trial protocol. We can find out if the patient meets these criteria once the patient visits our centre.
In the event that patient recruitment for a clinical trial has been closed or if the patient does not strictly meet the criteria for inclusion in the trial, access to the experimental treatment may be possible if the manufacturer facilitates access to the treatment.
This use of experimental drugs or products outside clinical trials is called "compassionate use" and must be approved by the health authorities, in our case the Ministry of Health.
For both the use of experimental treatments in a clinical trial and for compassionate use, the company that manufactures the experimental treatment funds the product (the drug).
If your child participates in the clinical trial, the study tests and treatment will be funded by the sponsor of the research. Tests that are not included in the protocol, that are part of the clinical follow-up of the patient, or in case of worsening of the clinical situation, should be financed by the patient.
In the case of access to compassionate use treatment, all medical tests must be financed by the patient.
In our hospital, in the case of international patients, an initial deposit of the amount indicated in the budget is required in order to start the medical care process. This budget is made including all hospital care costs, with the exception of the experimental drug, which is always financed by the sponsoring company.
After diagnostic confirmation and assessment of the extent of the disease, if there is a clinical trial and the patient meets the inclusion criteria, the hospital returns the part of the financial deposit made that corresponds to the medical tests included in the trial protocol, in compliance with the applicable legal requirements.
Clinical trials of vaccines
Vaccines have contributed to significantly reducing the prevalence of many childhood infectious diseases, such as diphtheria or measles, and some of these have been eradicated in Spain (for example, polio) thanks to effective vaccination campaigns. Most vaccines are given to healthy babies, children, and adolescents. Therefore, it is of vital importance to demonstrate that vaccines are safe and effective. Ensuring their safety and efficacy is one of the priorities of drug regulatory agencies.
If too many people choose not to get vaccinated or to not vaccinate their children, some rare or non-existent diseases may return.
A vaccine is a medicinal product. Like any medicinal product, vaccines have risks and benefits, and although they are very effective, none offer 100% protection against disease or are 100% safe for everyone. Most of the side effects are mild and brief.
To be sure of the efficacy and safety of vaccines in children and young people, it is essential to carry out clinical trials in these age groups that provide us with scientific evidence.
The Clinical Research Unit of SJD Hospital Barcelona has extensive experience in paediatric clinical trials, being the leading unit in Spain in paediatric clinical trials, thanks to the cooperation of patients and families.
Participation in clinical trials of paediatric vaccines
In the majority of clinical trials on vaccines, healthy children and young volunteers who are not suffering from any relevant underlying disease participate. If the vaccine is approved in the healthy child, in most cases, the indication is extended to the patient with an underlying disease if there are no contraindications.
Vaccine clinical trials are usually short in time and involve very close monitoring of the patient. In addition to the administration of the vaccine, blood tests should be performed, as a minimum before and after vaccination, and with the additional regularity required by the clinical trial.
It is always mandatory for the parents or legal guardians of the child or young person to sign the informed consent form. In addition, adolescents over 12 years of age must express their approval by signing a document known as informed assent.
In these documents, the patient and his/her family are informed of the reasons for conducting the clinical trial, for which his/her participation is voluntary, the procedures which are going to be performed and for how long, and the possible risks and benefits of participating in the study.
Children and young people are a very active and essential part of the scientific advance for the diagnosis and treatment of paediatric diseases, and also in clinical trials of vaccines. Since 2015, SJD Hospital Barcelona has promoted the Kids Barcelona programme, a group of children and young people who advise us and give children and their families a voice in the medicine, research and innovation that we carry out, and of course, in clinical trials.
Do you want to participate in one of our vaccine clinical trials?
If you are interested in knowing more about vaccines and the clinical trials on vaccines that are carried out at the SJD Hospital, you can check which studies need participants and sign up on the website of the Sant Joan de Déu Research Institute (IRSJD). Information in Spanish.
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“Children are not small adults and they deserve to be treated and cured with effective, safe drugs when they are sick. This is why paediatric clinical trials are necessary.”
Children and adolescents participating in clinical trials
Diseases we study
Clinical Research projects
Clinical innovation projects
Principal investigators leading trials
Information for professionals
We invite you to browse the information provided by the Sant Joan de Déu Research Institute to healthcare professionals about our services and the clinical trials we conduct, as well as other information we believe will be of interest to you.
KIDS Barcelona Project
KIDS Barcelona is a project spearheaded by the SJD Barcelona Children's Hospital that turns children and young people into advisers in order to improve the medical innovation and methods related to them and to adapt the information received about procedures that affect them to their capacities and their level of understanding.
If you want to know more about this project, we invite you to visit the website of the project.
KIDS Barcelona: young person’s advisory group
We explain what are the clinical trials to children and adolescents
Clinical trials for children are different from studies aimed at adults and have their own particularities. The education of young patients is essential, in order to anticipate and prepare their participation, but also to help them in their decision-making process.
In Spain, children over the age of 12 should, along with their parents or guardians, record their compliance to participate in a study of a new therapeutic option.
We explain it in this video, which has been developed with the collaboration of the Scientific Council of adolescents of the SJD Barcelona Children's Hospital.
Clinical trials explained for kids (caption in english)
Agreements and partnerships
In pediatric clinical research, cooperation between national and international institutions is indispensable. Our Unit has established agreements and alliances for cooperating with reference organisations, which allows us to push forward in research into drugs and treatments for children and adolescents.
- Joana Claverol Torres
- Pg. Sant Joan de Déu, 2, Consultes Externes Building, 0ª plant. 08950 Esplugues de Llobregat (Barcelona)
- +34 93 600 97 33