Sant Joan de Déu Barcelona - Hospital
Clinical Trials Experience

Do you want to know more about clinical trials?

Resources. 8 to 12 years old

  • Clinical trials are the studies that help to see how new drugs work to treat the different kinds of diseases. They give us very important information, like, for example, if they work correctly (improves patient’s health) and if they produce any side effects in the children studied (e.g. headache, fever, etc.). The benefits of the drugs must be always higher than the drawbacks.

  • It is a preparation of different compounds (biologic, chemical or cellular) that are used for the purpose of improving the health of the children who have a disease, to stop it or to prevent it. Not only do they help to relieve the symptoms of a disease: they are also used to diagnose diseases. For example: when we take a syrup in order to test how the syrup circulates through our stomach. In this case, this medicine helps doctors to know what kind of disease affects this organ.

    Medications may appear in different formats: pills, capsules, syrups, creams, injections ...

    Medical devices are devices used to diagnose or treat a disease. These are their main objectives:

    • Allow doctors to collect information. For example, a thermometer to measure fever or a glucose meter.

    • They serve to improve or treat the effects of the disease. For example, an inhaler to control an asthma attack or a syringe to inject insulin into diabetic children.

  • The only way to know if a medicine or treatment works correctly is to study them very carefully. It is very important to know how a medicine works not only in children in general, but also according to the age of those children. We cannot give the same amount of a drug to a 6-year-old child and to a 14-year-old teenager because, as children grow, the effects of the drugs change.

  • Clinical trials are very important for any kind of patient, but they are extremely important because many medicines and treatments that are given to children have only been studied in adults.

    • What are the best medicines that children should take when they are sick.

    •  If one medicine works better than another.

    •  If there is a better way to give a medicine, such as taking a tablet or pill instead of having an injection.

    •  If the use of different amounts of this medicine works better.

  • Sin ensayos clínicos, no podemos saber cuál es la mejor manera de dar un medicamento a los niños porque:

    • Los niños tienen enfermedades distintas a las de los adultos. 

    • Los cuerpos de los niños y los de los adultos son diferentes. Los niños tienen los pulmones más pequeños, menos músculo alrededor de los huesos, su corazón palpita más fuerte... Y están continuamente creciendo!

  • Sometimes, medicines given to children to treat a disease can cause an unintended effect, such as a headache or a rash on the skin. This is what we call a side effect. During the study of a medicine, it is very important for doctors to know whether there are any side effects in the children. If these harmful effects occur, they should always smaller than the positive effects that the medicine can bring to the child’s health.

  • Clinical trials are done in hospitals or medical centres.

  • There is a person who has designed the clinical trial, usually a doctor and/or a researcher, who knows the disease well and is looking for ways to improve the treatment.

    Clinical trials are reviewed by different people before they can begin. Permission is required from different groups of doctors, nurses, scientists, and non-physicians who review each study before it begins. The Spanish Medicines Agency monitors and controls the safety of all medicines and clinical trials in our country.

    There are very strict laws protecting the safety and well-being of adults and children in a clinical trial.

  • Doctors may propose parents and children with a disease to participate in a clinical trial, when:

    • There is no treatment to cure it and it is necessary to study a new one in children who present the disease.

    • When there is already a treatment but they consider that the new one may be better.

  • It is not mandatory. Parents and patient are free to decide. They will be given information to study, read, question ... and to take the final decision with time and help.

    If you accept to be part of a clinical trial, documentation will be given to you to sign. In the case of children under 12, parents or legal guardians are the ones who must sign this documentation to agree and give permission to participate in the clinical trial. This document is called informed assent.

    It is possible to change your mind and/or leave the clinical trial without giving a reason. This will not affect the patient's subsequent medical care and no one is going to be bothered about it. It will never affect the treatment that you may receive.

  • When a doctor asks a parent or legal guardian to give permission for their child to be part of a clinical trial, the document they sign is called informed consent.

    When 12-year-old children (or older) express their decision to accept participation in an essay, they do so by signing the informed assent document. In this case, their parents must also sign the informed consent document.

    Signing the informed assent document means that the boy or the girl understands what the study will consist in and really wants to participate.

    The doctor will be the first person to give the information to the parents and the patient, and he/she will explain the things that can happen during the test and answer any questions they may have. 

  • The answer is yes. Clinical trials are classified into different phases. In general, these phases are:

    Phase 1: the new drug is studied in a small group of patients, between 20 and 100 children, who take a very small dose of the drug so that it can be studied in case it is toxic. For example, if it damages their kidney or liver. In this case, the investigation of this drug will not be carried on.

    Phase 2: it usually involves a group of 100 to 300 patients, who are divided into different groups and given different amounts of the drug. This time of the investigation helps to obtain information on its positive and negative effects on the disease, and on its minimum safe and effective quantity according with the patient’s age.

    Phase 3: more patients collaborate, between 1,000 and 5,000, and this allows us to know if the drug is better than another drug or than a placebo (when no previous drug is authorized).

  • The goal of a clinical trial is to obtain information about medicines and treatments that may benefit other children.

    Although you may not benefit from the study, other children who will be treated in the future will benefit from it, because after the study we will know how safe a medicine or a treatment may or may not be.

  • It is necessary to fulfill a series of requirements established by the researchers (for example, a certain age or specific results in a blood test).

    These characteristics are called inclusion criteria when it is necessary to fulfill them, and exclusion criteria when they should not be present.

  • No one except the medical professionals involved will know that you are participating in a clinical trial. All medical tests that are confidential, as well as any other information related to your health.

    Doctors will not tell anyone that you are participating in a clinical trial, without first asking your parents.

  • The information gathered from all the patients who have participated is studied and discussed in scientific meetings, published as an article in medical journals and becomes accessible so that other physicians can help their patients by knowing how the studied drug has worked.

    Individual information is never published about the people who have participated in the trial, such as the name or contact address.

    A clinical trial finishes when it reaches Phase 3 and it has obtained positive results that allow the authorization of the drug.

  • There are two websites where all the information related to active clinical trials is openly published:

    European Register of Clinical Trials.

    Spanish registry of clinical studies.

    Finder of clinical trials in the United States.

    If a patient is interested in participating in a clinical trial but has not been invited, his parents should talk with his doctor or nurse. It is important to remember that not all patients meet the criteria to access a clinical trial.