Clinical research refers to scientific studies carried out on human beings with the aim of furthering knowledge in biology or medicine. It focuses on improving knowledge about how the body works, diseases, developing new treatments or medical devices, and developing diagnostic methods to better manage patients.
Clinical Research Framework
Clinical research follows a specific study protocol and is conducted only under certain conditions:
- Obtain consent from those involved in the research;
- Obtain regulatory approvals and have taken all the necessary legal and ethical steps;
- Be carried out by competent persons;
- Take all measures to protect persons suitable for research;
- Aim to increase biological and medical knowledge.
Three broad types of clinical research
There are three main types of clinical research:
- Non-interventional studies (e.g. cohort study, epidemiology, questionnaires, etc.): these studies improve knowledge about the human being, the disease and its evolution over time;
- Experimental studies with minimal risks and constraints: these studies aim to advance biological and medical knowledge through, for example, brain imaging techniques (MRI, EEG, etc.) sometimes coupled with cognitive or behavioural tasks (tests of perception, memory, decision, etc.).
- Interventional studies or clinical trials: these studies provide scientific evidence of the efficacy and safety of a new drug, device or management of a disease. This is the step necessary for a new molecule to become a drug or for a new medical device to be marketed.
