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Clinical Trials at the Vall d’Hebron Campus

We do research to solve people's health problems. Our work is not only basic or translational; we are leaders in clinical research. We have the hospital beds less than 50 meters away from the laboratories and our patients benefit from the research we carry out. We believe in this, this is what we strive for. This is also understood by industry leaders, who bet on our hospital when it comes to conducting their first clinical trials, thus making it a world reference.

 

What is a clinical trial?

Clinical trials are part of clinical research, which refers to the studies or projects focused on medical advances for people, either when subjects (patients or healthy volunteers) participate, or when a study is carried out with patient data and/or their biological samples are used. The aims of clinical research can be very diverse, for example, the evaluation of the efficacy and/or safety of new treatments (pharmacological, medical devices, psychological, surgical...) or diagnostic techniques, the study of the prevention of certain pathologies, risk factors and/or biomarkers of diseases or the study of the natural history of diseases.

 

Types of clinical research

Clinical research studies or projects can be classified according to their goals and design. Before any clinical research is initiated, it must be evaluated by a Research Ethics Committee.

Interventional study or project

It involves modifying the treatment and/or monitoring of a patient as a result of their participation. Examples of these studies are clinical trials with medication or clinical research with health-care products. Other clinical research projects such as those evaluating, for example, a new pattern of respiratory physiotherapy or a surgical technique are also included.

Observational studies or projects

The usual monitoring of the subject/patient is not modified as a result of their participation in the study, or it is modified only minimally (for example, adding a questionnaire that evaluates their quality of life).

Phases of a clinical trial

Before a clinical trial, preclinical studies are carried out. These are the first tests to study the effectiveness and safety of a new treatment, both in cells and in experimental animals. If positive results are obtained, clinical trials can begin on humans, which are classified into four phases.

  • In Phase I the safety of the medication, optimal dose and best means of administering the treatment are evaluated. This is carried out with a small number of participants.
  • Phase II analyses the effectiveness of treatment, not just safety. There will usually be between 100 and 300 people participating.
  • Phase III allows the effectiveness and safety of the treatment to be validated in a higher number of subjects. During this phase, the study treatment is compared with the current standard of treatment, should there be one. To make the results rigorous and objective, patients are usually randomly subdivided into two or more groups. One of the groups receives the new drug that is intended to be studied. The control group, on the other hand, receives a placebo (an inert substance) or a reference treatment. Whenever possible, patients and researchers do not know which group patients are in until the study ends, to avoid bias when analysing the results.
  • If good results are obtained, the medication can be approved for marketing, though it continues to be studied in the long term. This is known as Phase IV and its purpose is to detect, in clinical practice, uncommon adverse effects that may not have been detected in previous phases.
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