From 13 to 18 years old

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?

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.

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.

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.

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.

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.

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.

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.

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.

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.