Space for patients

The decisions in clinical practice regarding treatments to administer, or diagnostic methods to use or the evaluation of patients afflicted with a particular disease are taken by health professionals. These decisions are based on the Scientific Evidence generated and available at any given moment, which results from the research studies conducted primarily in human subjects and published over time in international scientific literature.

One of the most powerful and rigorous tools for generating scientific evidence and, consequently, for generating data which can be converted into clinical recommendations is the Clinical Trial.

A clinical trial is a research study involving human subjects which rigorously tests the efficacy and safety of treatments, drugs or diagnostic tests. Each study tries to answer scientific questions and to find better ways to prevent, diagnose or treat diseases. All the medicinal products, vaccines, diagnostic tests, etc. must first be studied in clinical trials before they are approved for public use.

Participation is voluntary and, as this is a research study, results cannot be guaranteed.

Types and phases

Phase I clinical study

This represents the first step in drug administration to humans. The objective of this phase is the detection and identification of: possible incipient signs of toxicity; forms of dispensing; the dose; safety, etc.

Phase II clinical study

After Phase 1 has been successfully completed, the study proceeds to Phase II. During this phase the drug is administered to people who have the disease for which the drug has been developed. The purpose of Phase II is to learn more about the therapeutic efficacy/toxicity relationship, and to establish the optimal dose or maximum doses to use in patients with the disease of the study.

Phase III clinical study

It is a more advanced stage prior to marketing the drug. The number of sick patients to whom the new drug is administered to demonstrate its benefits and safety is much higher. When the Phase III studies are completed and the sponsor can demonstrate that the drug is safe and effective under certain conditions, it is ready for the Health Administration to approve its release onto the market.

Phase IV clinical study

These studies are carried out when the drug is already marketed for a particular indication. This phase allows for more information to be given in relation to the safety of the drugs used by patients who may be receiving other treatments or have multiple diseases. It also allows for the appearance of long-term effects to be detected and identified, or for new indications to be studied.

How to participate

To participate in a clinical trial, the patient has to give his/her consent in addition to meeting all the screening criteria defined in the trial protocol.

For this, the subject will be informed and evaluated in a medical consultancy by members of the research team, who will determine whether the subject is fit or not to participate in the trial. If affirmative, the patient will be informed by the investigator regarding all the aspects related to the clinical trial. In case of conformity, the patient must sign the informed consent form in duplicate and he/she will be given a copy.

Personal data protection

The participants are entitled to have their data or donated biological samples treated confidentially. Identifiable data can only be accessed if the patient consents to it, and always in compliance with the Organic Law on Protection of Personal Data 15/1999.

Also the following regulations ensure adequate patient protection:

  • Law 16/2003 of 28 May, on Cohesion and Quality of the National Health System.
  • Royal Decree 1720/2007, of 21 December, approving the Regulation implementing the Organic Law 15/1999 of 13 December on the Protection of Personal Data.
  • LAW 41/2002 of 14 November, regulating Patient Autonomy and Rights and Obligations regarding clinical information and documentation.

Frequent questions

  • What are the patients' rights?

    Participation in a clinical trial is only possible if the person meets the specific conditions of that investigation.

    Participation is voluntary and must be based on a thorough knowledge of the project that will include among others: the objectives, the tests to be performed, the drugs that are going to be provided and the potential risks that participating in the study may include. The patient must also be informed of the treatment alternatives. The agreement to participate in the study is made in writing by signing a document called an informed consent form. If a patient is unable to give consent (minors and incapacitated adults), their legal representative may do so.

    The participants are entitled to receive a copy of the Subject Information Sheet and should be given details of whom to contact if questions or problems arise while participating in the study.

  • What are the obligations of the patients?

    It is very important that you inform your doctor of any disease you suffer or any treatment you are receiving, since its omission may pose a risk that is higher than wished for. It is also important to follow the investigator's instructions to ensure that the conclusions drawn are true.

    In the event of receiving assistance from medical personnel who are not involved in the trial it is important to inform them about your participation in a clinical trial and, if necessary, provide any information required in order to receive care that is adapted to the said situation.

  • Can I withdraw from a clinical trial?

    Participants can withdraw from a clinical trial whenever they want or when the investigator so decides. In no case will this circumstance affect their health care.

  • Is my participation in the trial covered by insurance?

    Participants should receive medical care for any problems that may arise during their participation in the study. The sponsor must contract an insurance policy, under the conditions established by law, to cover the treatment of adverse effects that may arise.

  • What results can I expect from a clinical trial?

    A trial does not guarantee results..

    Participation in a clinical trial does not guarantee any results. Obtaining benefit is a possibility but it is not assured. On the other hand, unknown adverse effects may appear.

  • What regulation must clinical trials meet?

    The performance of any clinical trial in Spain is governed by laws similar to those that apply in the rest of the European Community. These laws include:

    • Royal Decree Legislative 1/2015, of 24 July, approving the revised text of the law on Guarantees and Rational Use of Medicines and Medical Devices. (BOE No. 177 of 25 July 2015).
    • Royal Decree 1090/2015, of 4 December, regulating the clinical drug trials, the Research Ethics Committees and the Spanish Register of Clinical Studies.
    • Order of the Ministry of Health 256/2007 on Good Clinical Practices in Research.
    • Law 14/2007 of 3 July, on Biomedical Research.