Clinical Research
Clinical research refers to all scientific studies conducted on human subjects. It is essential for better understanding and/or treating diseases, as well as for identifying potential risk factors. There are two types of clinical research:
- Non-interventional studies (cohort studies, case-control studies, etc.): Studies in which researchers observe patients by tracking changes in their health status over a certain period of time. These studies help improve our understanding of a disease and how to treat it.
- Interventional studies or clinical trials: These provide scientific evidence of the efficacy and safety of a new drug, a new medical device, or a new treatment approach for a specific disease.
Specifically in the context of new drug development, clinical trials take place in four well-defined phases:
- Phase I studies: Studies involving the first administration of a new product to humans, aimed at determining the product’s tolerability in humans;
- Phase II studies: pharmacological efficacy studies designed to determine the minimum effective dose of the new product;
- Phase III studies: studies of therapeutic efficacy. These correspond to the final phase before the new product is marketed as a drug. They aim to measure the therapeutic efficacy and tolerability of the new product under conditions that closely resemble real-world use;
- Phase IV studies: studies conducted after the drug has been marketed. They aim to monitor the long-term use of the drug under real-world conditions.
The PACCI program primarily conducts Phase II and III trials.
