Clinical trials: the patient's perspective

What are clinical trials?

Clinical trials are research studies performed in humans. They try to find out how the body reacts to a given treatment. When a new drug is developed, it is essential to carry out a clinical trial in people to verify its efficacy and safety.

Clinical trials are not only necessary from a scientific point of view, as they are also legally mandatory. In other words, drug regulatory agencies compel the promoters of the new treatment or new therapy to carry out this study. They must demonstrate its safety and its effectiveness. In addition to medicines, clinical trials are also necessary for other health products such as vaccines, diagnostic tests and medical devices.

Are clinical trials different from common clinical practice?

Clinical trials take place in hospitals and are different from the common clinical practice. When a patient receives medical care, the doctor’s goal is to treat his or her illness. However, when someone participates in a clinical trial, the goal is to find a solution to what is being investigated, that is, to confirm (or not) the efficacy and safety of a treatment.

Medications and therapies used within a clinical trial are outside common clinical practice, that is, they can only be accessed by participating in a trial and not in the framework of an ordinary medical consultation. However, it is the same doctors who deal with routine clinical practice who monitor clinical trials and are in contact with participating patients.

Patients who participate in a clinical trial receive much closer monitoring by the health personnel who are part of the research, in order to ensure their safety and document the effects of the treatment as much as possible. This means going to the consultation more frequently, more follow-up checks and more tests.

Who has a role in clinical trials?

Patients (and the treatment under investigation) are at the center of any clinical trial. However, there are more roles involved in clinical research. This the list of people or organizations involved in any clinical trial:

Promoter: is the organization that develops the drug (in most cases they are pharmaceutical companies, but they can also be independent researchers).
Principal Investigator: is the doctor who conducts the trial and is in contact with the patients who participate.
Patient of a clinical trial: is the person who voluntarily, freely and informedly participates in the study of the new treatment. This person is assigned in advance a specific therapeutic strategy that is not part of common clinical practice.
Ethics Committee: it ensures that the trial is conducted ethically, respecting the rights of the patient who participates in the trial.
Clinical trial monitor: is the person who monitors the clinical trial to ensure that it is carried out according to the established protocol and in compliance with all procedures.
CRO (Contract Research Organization): is the organization contracted by the sponsor to perform functions or duties on its behalf, regarding the clinical trial.