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Clinical research is a scientific activity in which people participate, as either patients or healthy volunteers or in which their data and / or their biological samples are studied. Thanks to clinical studies, scientists advance in the knowledge of diseases and may find new and better ways of detection, diagnosis, treatment, and prevention of diseases.

Clinical research studies can be classified according to their design and objectives. We speak of an interventional study when the treatment and / or follow-up of a patient is modified as a result of participation in the study. These studies are clinical trials with medications or with medical devices, based on specific legislation that applies to these types of studies. Other clinical research projects such as those that evaluate, for example, a new pattern of respiratory physiotherapy or a surgical technique are also considered within this definition. Interventional studies are the most powerful and rigorous tool for the generation of scientific evidence and, therefore, for transferring the findings into clinical recommendations. All medicine, vaccines or diagnostic tests must first be evaluated in clinical trials before their approval for public use.

When the usual follow-up of the study subject/patient is not modified as a result of participation in the study, or the modification is minimal (for example, when adding a questionnaire of evaluation of the quality of life), the study is considered to be observational. Observational studies collect information about the natural evolution of the disease to understand how it progresses over time. When the objective of the study is to evaluate the use of authorised medications according to their approved indications, the study is called a post-authorisation study (EPA) and they are subject to specific legislation..

Before a new drug is approved and can be taken to the market, two stages are distinguished:

  • a preclinical phase, which includes laboratory studies and animal studies
  • a clinical phase, in which clinical studies are conducted in humans

The first phase takes place in a laboratory. Of all the substances that are tested in a laboratory during these early phases, very few will pass to a phase where the substance is tested in humans. Preclinical studies include:

  • Cellular studies: these are the first tests performed to study the efficacy of a new treatment. Researchers analyse the effects of the new treatment on cells that have been grown on a laboratory plate or in a test tube.
  • Animal studies: treatments that seem promising based on cellular studies are tested on live animals. This gives researchers an idea of the behaviour of the new treatment in a living being.

Preclinical studies provide very useful but insufficient information on the safety and efficacy of the drug, after all, humans and animals are different. A drug that works in animals may not work in humans or there may be side effects and other problems that do not occur in animals but may occur in humans. Therefore, if the preclinical results are promising, and after reviewing all the information provided by the researchers, the Regulatory Bodies will grant an authorisation for the new drug to be tested in humans in a clinical study.

Within the clinical studies, a series of phases must also be overcome before the final authorisation for commercialisation of the drug can be given. Each one is designed to answer certain questions and ensure the safety of the participants.

Phase I

Phase I studies are clinical trials where a new drug is administered to humans for the first time. Participants in this phase are usually a small group of healthy volunteers (from 20 to 80 individuals). The objective of the study is to evaluate the safety of the drug, to detect and identify possible incipient signs of toxicity and side effects, how the drug is distributed by the body, and establish the best form of dispensing and dosage.

Phase II

In this phase, the drug is administered to people who have the disease which it has been developed for. The total number of patients is still small (several hundreds of people). The purpose of a Phase II study is to know more about the therapeutic efficacy/toxicity relationship, as well as to establish the optimal dose or the maximum doses of the drug.

Phase III

Phase III is the most advanced phase before taking the drug to the market. The number of patients in these studies is larger (from several hundred to several thousand, depending on the pathology) and the purpose is to evaluate the efficacy and safety of the drug. When the Phase III studies have been completed and the promoter of the drug has demonstrated that the medication is safe and effective under certain conditions, the Health Administration can approve its release to the market.

Phase IV

Phase IV studies are conducted when the drug is already in the market. They are important to collect additional information on the long-term safety and efficacy of the drug in real-life conditions, to find possible interactions with other treatments or concomitant diseases or to study new indications.

Anyone can participate in a clinical study as long as their participation is entirely voluntary and when the participant gives informed consent and meets the specific selection criteria defined in the study protocol..

Participation in a clinical study is completely voluntary. Also, if you decide to participate, you can change your decision and withdraw your consent at any time and for any reason without suffering any penalty or loss of the benefits to which you are entitled to. If you decide to withdraw your consent, your relationship with your doctor will not be altered, you will not suffer damage to your health care or treatment nor it will affect your participation in future studies.

A member of the research team will propose you to participate in a clinical study, inform you about all aspects related to the study and assess your health status in a medical consultation, determining whether or not you are eligible to participate. If you are eligible and willing to participate, you must give your consent in writing by signing a document called informed consent.

Informed consent is a process that must always be carried out before beginning your participation in a study. A member of the research team will give you all the relevant information about the study, which will include, among others: the objectives, the tests that will be performed, the medications that will be provided, and the possible risks and benefits of your participation. You will also be informed about the existing therapeutic alternatives for the treatment of your disease. Besides, you can ask all the questions you want to clarify your doubts and concerns and consult with the people you deem appropriate (family, friends...). The agreement for participation in the study is made in writing by signing a document called informed consent. You have the right to receive a copy of it and have a point of contact to go to in case of doubts or problems during your participation in the study.

If a patient is not able to give his/her consent on his/her own, like in the case of children and the disabled, their legal representative may do so after receiving all necessary information.

Like any medication, test or routine medical procedure, all clinical studies present risks. If you decide to participate in a clinical study, a member of the research team will inform you about possible adverse effects and evaluate with you if the expected benefits outweigh the risks. During your participation in the study, you will receive continuous medical attention for any problems that may arise. In addition, the sponsor of the study will contract an insurance that complies with current legislation (Royal Decree 1090/2015) and will provide compensation in case of impairment of your health or injuries that occur in relation to your participation in the study, provided that they are not a consequence of the disease itself or the evolution of the disease as a result of the inefficiency of the treatment.

Participation in a clinical study does not guarantee positive results. There is the possibility but not the certainty of obtaining benefits for your health.

Participants have the right to have their personal data treated confidentially. The sponsor commits to comply with the Organic Law on the protection of personal data and guarantee of digital rights (LOPDGDD 3/2018) and the European General Data Protection Regulation (GDPR 679/2016). The processing, communication, and transfer of personal data of all participants will comply with the provisions of this law, according to which access to identifiable data can only be made if you have given consent to it. You also have the right to modify, oppose and cancel your data, for which you should contact your study doctor.

The data collected for the study will be identified by a code so that it does not include information that enables the identification of the participants. Only the research team will be able to relate such data to the participants and their medical history. Your personal data will not appear on forms, in the study database, or the publications of the results. Therefore, your identity will not be disclosed to any person except in case of medical urgency or legal requirement.

If any participant decides to withdraw his/her consent to participate in the study, no new data will be added to the database, but those that have already been collected will be used.

It is very important that you inform your doctor of any illness you suffer from or any treatment you are receiving, since omitting this information may pose a risk. It is also important to follow the indications of the research team so that the conclusions obtained are reliable.

In case of receiving assistance from medical staff who is not involved in the study it is important that you let them know about your participation in a clinical study and, if necessary, provide the required information in order to adapt the medical attention accordingly.

Participants in a clinical study will not have to pay for medications or for specific tests that are part of the study. The sponsor of the study may reimburse the extraordinary expenses (for example, meals and transport) incurred due to participation in the study.

The sponsor of the study is responsible for managing its funding. For the conduction of the study, the sponsor has signed a contract with the principal investigator of the study and with the site where it will be conducted.

As a general rule, patients will not be paid for participating in a clinical study. In certain studies due to their characteristics (early phases without therapeutic benefit) participants will be compensated for the time spent on the study or for the inconvenience it may cause, in proportion to their participation.

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