From 8 to 12 years old

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.

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.

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.

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.

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).

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. 

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.

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.

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.