Clinical trials ~ UNIPI

Clinical research, or a clinical trial, is a study conducted on human participants to evaluate the clinical, pharmacological and pharmacodynamic effects of investigational medicinal products or medical devices. Studies may also aim to identify potential adverse effects and to understand processes of absorption, distribution, metabolism and elimination, in order to assess safety and efficacy.

University-led trials play a central role in therapeutic innovation and in the advancement of scientific knowledge. They are often dedicated to new treatment strategies, the optimisation of existing therapies, the study of rare diseases, or clinical questions of particular relevance to the healthcare system. In these studies, the University may act as sponsor or provide support for clinical trials promoted by pharmaceutical companies, ensuring independence, transparency and methodological rigour.

The conduct of these studies requires the involvement of the University Hospital, approval of the protocol by the Ethics Committee, and compliance with Good Clinical Practice (GCP) guidelines, in order to safeguard the safety and well-being of participants.

Clinical activities at the University of Pisa are centred on the patient, who is actively involved in decision-making processes. The patient is never regarded as a mere subject of study, but as an informed and aware participant.

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Clinical trials