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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. The study is carried out under the supervision of a team of doctors and health professionals who follow a protocol. This protocol and all documents addressed to the volunteer must be approved by the Clinical Research Ethics Committee and be authorised by the Spanish Agency for Medicines and Health Products.

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

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

- Phase I clinical trials: these involve the first doses given to human beings. They are aimed at detecting and identifying possible incipient signs of toxicity, studying the way they pass through the body, which we call pharmacokinetics. This phase usually involves a small number of healthy volunteers.

- Phase II clinical trials: these studies are carried out on people with the disease for whom the drug would be prescribed in the future. They provide exploratory data on efficacy, safety information and the most appropriate doses.

- Phase III clinical trials: these are designed to confirm the efficacy and safety results of Phase II using a larger number of patients, prior to marketing.

- Phase IV clinical trials: these are the studies that are carried out when the drug is already on the market and allow us to learn more about safety aspects in patients with other diseases or who are receiving other treatments.

How can I take part in a clinical trial?

Participation in a clinical trial is voluntary. Applicants can get in touch the staff in our Unit. You can do this through the announcements on our website, contacting us either by email at imatilla@imim.es or by phone on 933160496.

Once an applicant contacts us, they will be asked a few questions so that they can register and they will be informed of the studies that are active in the Unit.

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 contact person 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.

Is it safe to take part in a clinical trial?

Yes. It is important to note that clinical trials are highly controlled and performed according to protocols. Trials cannot advance from one phase to another unless it is demonstrated that the benefits outweigh any potential risks. However, as with all medicines on the market, a participant may experience an adverse reaction, which, in most cases, will be mild.

Can I leave a clinical trial?

Participants can leave a clinical trial whenever they wish or when the researcher considers it appropriate. 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 a possibility but no certainty of a beneficial outcome. On the other hand, there could be adverse effects that are not yet known.

Is it free to participate in a clinical trial?

As a general rule, healthy people who take part in Phase I trials receive 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.

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.

How are participants protected? Will my information be safe?

In a clinical trial, the participants' data is kept strictly confidential in order to guarantee their right to personal privacy. These studies are carried out taking into account the fundamental rights of the individual and the ethics standards that affect biomedical research, in line with the most up-to-date provisions of the Declaration of Helsinki. Specifically, the data collected from each participant is stored under a code, without identifying them by name, so that their identity is not revealed. In addition, this data is used for study purposes only and the confidentiality of this data must be protected by the staff involved in the clinical trials. Participants can access the information collected through their doctor and ask for any errors in the information to be corrected. If the results of the study are published, their identity will also be kept confidential.All data provided to the Clinical Research Unit (CRU) will be treated in accordance with current data protection regulations, the General Data Protection Regulation and Organic Law 3/2018, of 5 December, on the protection of personal data and guarantee of digital rights. In accordance with what is stated in the aforementioned legislation, the participant may exercise their rights of access, modification, opposition and cancellation of the data, for which they should contact the research staff at the CRU (voluntarisassaig(ELIMINAR)@imim.es).

What will happen when the study finishes? Will I get the results?

When a volunteer's participation ends, it is possible that other volunteers may still need to continue making visits and there may be biological samples remaining in the laboratory for analysis. At the end of the trial, a report is made and sent to the AEMPS and the CEIM. This is sent within one year of the last visit of the last patient recruited, but sometimes there are evaluations that will require even more time. The results are documented in aggregate form (without identifying participants) in the reports and in public records that can be consulted on the internet. Some studies also hold debriefing sessions for participants to discuss the results.

What is informed consent?

Informed consent is the document used to ensure that each participant understands the clinical trial, understands their rights, and is aware of their commitment. Prior to the start of any clinical trial, this consent must be expressed in writing and a copy of the information must be given to the volunteer.

Informed consent is accompanied by an Information Sheet describing the purpose, duration, tests and procedures to be performed, treatment to be administered during the study, benefits and risks of the clinical trial, as well as information on study funding, sponsors, institutional affiliations, management of collected data or sample management, potential conflicts of interest and incentives for study subjects, the EU General Data Protection Regulation, and information on provisions for treating or compensating subjects who may suffer harm as a result of their participation in the research.

The participant will be given the necessary time to read and assimilate the information. Therefore, by signing this informed consent document, the participant confirms that they understand the trial and agree to participate.

It should be noted that consent is not a contract and the participant is free to withdraw from the trial at any time.