There are many reasons why people wish to take part in our centre's clinical trials: the opportunity to help people suffering from medical conditions, access to investigational treatments before they become widely available, the chance to play a role in discovering treatments, cures and prevention for certain diseases or medical conditions, the ability to play a more active role in their own healthcare, access to free physical examinations and diagnostic tests related to the clinical study, the potential for compensation for time and travel related to the clinical study…

If you are interested in taking part in any of the trials currently open at H.U. Puerta de Hierro Majadahonda, you can contact our Single Point of Contact and we will get in touch with you.

Frequently asked questions

What is a clinical trial?

A clinical trial is a scientific experiment in which a person may take part voluntarily. As it is a scientific experiment, the trial conditions are carefully controlled and closely monitored. In general, the aim of a clinical trial is to assess the safety and efficacy of an experimental drug, medical devices or diagnostic methods in patients with a specific disease or in healthy individuals

For a new drug to be approved by the regulatory authorities, it must go through different development phases. To find out which phase your study is in, you can consult the doctor responsible for the study. Clinical trial phases can be Phase I, II, III, IV.

What is a Phase I clinical trial?

The aim is to generate preliminary information on the safety, absorption, metabolism and elimination of the new treatment. In this type of trial, the experimental treatment is administered to healthy participants. (In Oncology 2)

• What is a Bioavailability study?

This is a Phase I clinical trial in which the bioavailability of one or more drugs is compared. Bioavailability is defined as the rate and extent to which the active ingredient or active fraction of a drug is absorbed and becomes available at the site of action. (For example, from when a paracetamol tablet is taken until it reaches its target in the back to relieve pain in that area).

• What is a Bioequivalence study?

This is a Phase I clinical trial in which bioequivalence between two formulations is established. Bioequivalence is defined as the absence of a significant difference in the bioavailability of the formulations when administered at the same dose and under similar conditions in an appropriately designed study. These may be, for example, two different formulations (tablets versuscapsules) of a drug in development or a generic medicine.

In the case of generic medicines, the aim is to compare the characteristics of two medicines from different manufacturers to establish their similarity, and the original medicine must have been available in pharmacies for at least 10 years. This is why, in these studies, efficacy or safety, which are already well established, are not investigated; instead, the aim is simply to compare their absorption, metabolism and elimination in healthy volunteers.

What is a Phase II clinical trial?

This type of trial is the second step in developing a new drug in humans. Phase II studies are generally carried out with people who have the disease or condition for which the new drug is being developed. The aim of these studies is to provide information on the drug's efficacy and additional information on its safety.

What is a Phase III clinical trial?

This is the final phase of developing a new drug. The dose-effect relationship, efficacy and safety of the new drug are studied. This phase completes the development of the new drug, and permission is then requested to market it for the condition it has been tested for.

What is a Phase IV clinical trial?

This is carried out with the drug already approved and on the market. It is usually conducted under real-world conditions of use. The aim is usually to measure the drug's long-term effects.

Who regulates clinical trials?

The Spanish Agency for Medicines and Medical Devices regulates good practice guidelines for clinical trials. These must be conducted in accordance with the recommendations for Clinical Trials and drug evaluation in humans set out in the Declaration of Helsinki, as revised at successive World Medical Assemblies, and in accordance with current Spanish legislation on Clinical Trials. The Trial protocol is reviewed and approved by an independent Clinical Research Ethics Committee (CEIC).

What should I do before considering my participation?

First, you will receive an information sheet and informed consent form to read and sign. This contains all the information to consider about a clinical trial. Read it carefully, two or three times, and if any aspect is not clear to you, ask the study doctor or research team. Each clinical trial is different, and the benefits and risks vary. The consent information is your best source of information.

How does participation in and withdrawal from a clinical trial work?

Participation is voluntary, and if you decide to withdraw, this will not result in any penalty or affect your medical care. Volunteers may also be withdrawn from the study if the study doctor or research team consider it preferable for their health or well-being.

Who can take part in clinical trials?

Each trial is different, as are those who can take part. In general, in studies involving patients, it is your doctor who will tell you about the possibility of taking part in the study, explain what it involves, the procedures to be followed, etc. They will give you the Information Sheet so you can read it carefully and raise any questions. They will also inform you that you can withdraw from the study at any time if you wish.

In studies with healthy volunteers, participants are usually adult men and women in full possession of their mental faculties who, after undergoing a medical history, physical examination and other complementary tests, are shown to meet the health criteria specified in the study protocol

Could participation cost me anything? Will I be paid?

In general, there is no cost for participants in clinical trials. In some studies, volunteers are paid for their participation. The compensation is proportional to the duration and inconvenience involved. It is a modest amount to cover travel and inconvenience related to the study, and will vary depending on the visits or admissions required by the study.

What happens to the information collected about me?

The information collected on participants will only be used for the purposes of the study. The information will be stored without identifying you by name, and your identity will not be disclosed to anyone, except in the case of a medical emergency or legal requirement. All staff involved in the trial are required to protect the confidentiality of your data in accordance with the Spanish Organic Law on the Protection of Personal Data (15/1999 of 13 December). Participants may access the information collected through their doctor and request that any errors be corrected. If the study results are published, your identity will also remain confidential.