Sant Joan de Déu Barcelona - Hospital
Clinical Trials Experience

Do you want to know more about clinical trials?

Resources. 13 to 18 years old

  • Clinical trials are studies designed to answer specific questions about how a certain drug affects health or a particular disease.

    These types of studies give us important information about the benefits and safety of a treatment.

    • Drugs to treat pain, infections, blood pressure or other diseases.
    • Vaccines to prevent infections. For example, measles, mumps or rubella vaccine.
    • Medical devices such as plasters, bandages, or blood sugar measuring devices (glucose).
    • Physical therapies: different types of exercise are included to strengthen muscles after sport injuries or to help with balance and movement problems.
    • Psychological or behavioral therapies. These are designed to help us with the way we think about our problems.
  • The only way to really know if a medicine or treatment works is by studying them very carefully. A new treatment may be better than an existing one, and to determine this matter a clinical trial will be necessary.

    Clinical trials are important studies in which doctors and researchers compare treatments. In case there is no prior treatment for the disease that we want to treat, we will compare it to a placebo, a simulation of a treatment.

    Doctors and researchers carefully study the data collected during the investigation to find out if a treatment is effective, safe and how it should be administered correctly in children and teenagers.

    To decide the level of effectiveness of a treatment we need:

    • To know the effect it has on the body of teenagers like you.

    • To know that it is safe and that the side effects are minimal compared to the benefits.

    Clinical trials are very important for patients, but it is extremely important to study treatments for teenagers because many of them have only been studied with adults.

    Teenagers and adults often have different health problems, so treatments can work and react differently, and, consequently, have different side effects.

    Clinical trials are conducted to study and test new treatments, but they may also be used to study the possibility of combining treatments in order to make them work better.

  • In hospitals and healthcare centres.

  • The principal researcher (IP) is the person who has thought and designed the study. He is usually a doctor or another health care professional who has knowledge about the disease related with the treatment that will be studied.

    Before a clinical trial begins, it must be approved by an Ethical Medical Research Committee (CEIm) and by the Spanish Agency for Medication and Healthcare Products. The committee is independent of the group of doctors, nurses, researchers and non-medical professionals who will participate in the execution of the trial. The comittee will examine the study in great detail to evaluate its quality and assess the benefits and risks involved.

    The IP will send the reports of its clinical trial proposal to the CEIm of the correspondent research centre, so that they are evaluated and the authorization for their initiation is achieved.

    There are strict rules that protect the rights, safety, well-being and dignity of the people involved in a clinical trial. All patients are carefully observed during the study, because their safety and well-being is a priority. For this reason, more tests and medical appointments are performed during a clinical trial.

  • Perhaps because a treatment study is being conducted for a health condition or a disease that you have.

  • No. It is a free decision. All the information about the study and the new drug will be given to you so that you can read it and study it. In case you decide to join, and if you are over 12 years old, you must sign a document saying that you agree. This document is called informed assent.

    Your parent or legal guardian must also sign another document, which is identified by the name of informed consent.

    Even if you have signed the documentation to be part of the clinical trial, you are free to change your mind at any time and decide to leave the study.

    If you decide not to join or you want to suspend your participation once the study has begun, it will not affect you at any level and no one will be bothered about it.

  • The answer is yes. Treatments are firstly studied in laboratories, in order to see if they can be beneficial to prevent or treat a disease. Before doing research on people, studies are made with cell lines and animals to test their safety and seehow they affect the body.

    When researchers are sure that a drug is safe and useful, studies are performed with people through different phases. We can group the studies into two major stages: early phases and later phases.

    The early phase usually includes a small number of patients or a healthy population. In the case of studies foused in pediatric patients, healthy children will never be included in any of the study phases. The goal of this phase is to check the safety level of the drug before studying it with a larger group of children.

    The later phases include a larger number of people, and aim to find the dose that works best according to age groups and the benefits that this treatment can offer compared with other treatments that may exist.

    In these phases usually patients are randomly divided in order to be able to make comparisons. This process is called randomization or scrambling.

    Both phases are also performed with studies related to medical devices, such as a new glucose meter or pacemaker.

  • The objective of a clinical trial is to improve the treatment of patients or to be able to study a new treatment in the case of diseases that do not have a treatment yet.

    You should consider that you might not benefit directly from the study, but that in the future other people may be benefited because we will know if the treatment is effective and safe.

    Talk about this topic with your family and friends, doctors, nurses and researchers. Having detailed information will make it easier for you to make a decision.

  • Consent is the process that involves asking the parent or legal representative of a minor patient to give permission for participation in a clinical trial. Previously, researchers explains in detail what the study consists of, how it will be carried out and asnwers all the questions or doubts that the parents and the child may have.

    The document that your parents will sign to record that the information was received and they accept your participation in the clinical trial is called informed consent.

    When a child is given information about a clinical trial and he or she is asked if he or she wishes to be part of the study, the process is called assent. The document that the teenager will sign once he or she has received and understood all the information, and that serves to accept the participation in the clinical trial is called informed assent.

  • These are conditions or characteristics that patients must have to participate in a clinical trial. For example, a study may demand as a requirement that the patient has a certain age (13 and 18 years old) and also specific results in blood analysis.

  • These are conditions or characteristics that, when present in the patient, will exclude him or her from participating in a clinical trial.

    For example, taking a particular drug or participating in another clinical trial.

  • It is a treatment that does not contain any active substance but has the same appearance of a drug. For example, a capsule filled with sugar.

    The placebo is needed because sometimes patients can start to feel better when they take a pill, not because the medication is working well but because they are being treated. By comparing a group of patients taking the drug with one who thinks they are taking the drug (the one who takes the placebo), doctors will be able to study whether the drug actually works or not.

    Not all clinical trials include the use of a placebo.

  • All medical records of your participation in the trial are confidential, as well as any other medical information kept in the hospital. Researchers cannot tell anyone that you are participating in the study, without first asking your parents for permission.

    There are very strict regulations to ensure that personal information is kept confidential.

  • At the end of the study the results are available to all participants. Once the trial is over, the results are usually presented at research conferences and published in scientific journals, in order to make the information accessible to researchers or doctors from other countries interested in using this information to help their patients.

    Remember that personal information that may identify you as a study participant (such as your name or address) will never be shared in any congress or scientific journal.

  • There are lists (records) on the Internet where this information is collected and accessible to anyone who wants to consult it.

    If you want to be part of a clinical trial but you have not been asked, you should discuss it with your doctor or nurse, in addition to talking with your parents. They may know what is good for you.

    There are not always adequate clinical trials for you or the disease you are suffering from.

    There are some questions you should ask yourself before deciding to participate in a trial:

    • What is the purpose of the trial and how can it help children and teenagers?

    • What treatment would you receive if you did not take part in the trial?

    • What is the expected duration of the trial and how long will you be participating?

    • What medical tests or extra visits will you have?

    • Will it affect your school life?

    • What are the possible side effects of the treatment?

    • Who can you contact in case you have a problem? How?