Resources. 13 to 18 years old

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.

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 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.

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.

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.

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.