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Information for volunteers

What is a clinical trial?

A clinical drug trial involves research on humans to see if a drug is effective and to learn about its safety profile. Participation is voluntary and, as this is research, the results cannot be guaranteed.

Are there any differences between clinical trials performed using the same drug?

Yes. Each clinical trial has objectives that may differ from those of another trial, even though they are looking at the clinical response to the same drug.

The development phases involved in research using humans can be classified into four phases.

• Phase I clinical studies: this is the first step in administering the drug to humans. The goal of this phase is to detect and identify possible incipient signs of toxicity, administration methods, doses, and so on.
• Phase II clinical studies: once Phase I has been successfully completed, Phase II can begin. In this phase, the drug is given to people who have the disease for which the drug has been developed. The purpose of Phase II is to learn more about the relationship between therapeutic efficacy and toxicity, and to establish the optimum dose or maximum doses to be used in patients with the disease under study.
• Phase III clinical studies: this is a more advanced stage, prior to the marketing of the drug. The new drug is administered to a much greater number of sufferers, in order to demonstrate its benefits and safety. When the Phase III studies are complete, and the developer can demonstrate that the drug is safe and effective under certain conditions, it must then be approved for launch by the Health Administration.
• Phase IV clinical studies: these studies are carried out when the drug is already on the market for a certain treatment. This phase enables more information to be collected on the safety of the medicines used by patients who may be taking other medications or who have several diseases. They are also used to detect and identify any effects of the medicine that appear over time, or study new indications.

How can I take part in a clinical trial?

Participation in a clinical trial is voluntary. Usually, participants contact us through announcements on the website or are people who have previously expressed their interest in taking part. To participate in a clinical trial, the applicant must provide written consent, in addition to meeting all the selection criteria defined in the trial protocol.

In order to do this, nursing and medical members of the research team inform and evaluate the applicant in a consultation, in which they explain what the study involves, answer any questions, and determine whether or not the applicant is eligible to participate in the trial. If the applicant agrees, they sign the informed consent form and are included in the trial.

What rights do patients have?

• Participation in a clinical trial is only possible if the person meets the specific conditions of the research.
• Participation is voluntary, and must be based on a thorough understanding of the project including, but not limited to: the objectives, the tests to be conducted, the medications to be provided, and the potential risks involved in participating in the study. Patients should also know about any alternative treatments. The agreement to participate in the study is made in writing by signing a document called an informed consent form.
• Participants have the right to receive a copy of the patient information sheet, as well as a point of contact they can approach if they have questions or problems during their participation in the study.

What obligations do patients have?

It is very important that you inform your doctor of any illnesses you have or any treatment you are receiving, as failure to do so may pose a greater risk than is desirable. It is also important to follow the researcher's instructions so that the conclusions drawn from the use of the medicines are realistic.

If you receive healthcare from medical practitioners who are not involved in the trial, it is important that you let them know that you are participating in a clinical trial and, if necessary, provide the necessary information for them to adapt your care to this situation.

Can I leave a clinical trial?

Participants can leave a clinical trial whenever they wish or when the researcher decides. Under no circumstances should this affect your medical care.

Is my participation in a clinical trial covered by insurance?

Participants must receive medical care for any problems that may occur while they are participating in the study. The developer must take out insurance under the conditions set out in the clinical trial regulations.

What results can I expect from a clinical trial?

For a clinical trial to be authorised, it must be adequately justified and explained in terms of the current situation, and be well designed, but participation in a clinical trial does not guarantee results.

Research attempts to answer the question of whether a drug is useful for treating a specific disease with acceptable tolerance. For this reason, there is the possibility, but no certainty, of a beneficial outcome. On the other hand, there could be adverse effects that are not yet known.

Is participating in a clinical trial free?

As a general rule, healthy people who take part in Phase I trials receive a small compensation for their participation, since the studies are not intended to demonstrate the efficacy of a drug. Everyone who takes part in a trial, in any of the phases, must receive the medication being studied free of charge; this will be provided by the study developer.

Any tests carried out solely for research purposes should not be charged to the participants. Any other tests, not related to the trial, must be paid for.

Which regulations do clinical trials have to comply with?

All clinical trials carried out in Spain are regulated by legal standards, similar to those applied to the rest of the European Community. This guarantees that any clinical trials that are started have been previously evaluated by a Research Ethics Committee for medicines and authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS), who ensure that the trial complies with the corresponding ethical, legal and methodological requirements.