Pharmacovigilance in no profit clinical research. Requirements and challenges

Abstract

The goals of Pharmacovigilance (PV) include early detection of new adverse reactions, broadening information on known reactions, identifying risk factors, comparing drug safety profiles, and effectively communicating safety information to healthcare professionals. In non-profit clinical research, PV activities often face challenges due to limited resources and training. An exploratory survey by the Italian Data Manager Group in 2022 highlighted critical issues in non-profit clinical trials, such as the lack of multidisciplinary support and insufficient training in PV. To strengthen PV in non-profit studies, continuous professional development and adequate resources are essential. Ensuring the presence of dedicated, well-trained professionals and promoting the use of updated tools and processes can significantly improve the management of PV activities, ultimately safeguarding patient health and maintaining high-quality research standards.