Clinical research: the great absentee of the Italian University training programs?

Abstract

Background: In an era where clinical trials have become more and more complex and regulatory authorities impose very high quality standards, the education of clinical research professionals becomes crucial. As one of ICH-GCP guiding principles, adequate training should be ensured and included in educational programs. Methods: In 2021, the Italian Group of Data Managers and Clinical Research Coordinators shared among professionals involved in clinical research an online survey aimed at investigating quality and characteristics of clinical research training provided during undergraduate and postgraduate Italian programs. Results: The survey was completed by 280 professionals: 178 study coordinators, 29 clinical research associates, 20 project managers, 7 study nurses, and 44 others. The majority were 25-45 years old (n = 242, 86.4%), worked at experimental sites (n = 211, 75.4%), and almost all (n = 252, 90.0%) had at least a master’s degree, mainly in biology/biotechnology (n = 162, 57.9%) and pharmacy (n = 64, 22.9%). Clinical research education during the degree courses was considered poor by 73.6% (n = 206). The knowledge on clinical research professional world at the time of graduation was considered poor by 71.1% of participants (n = 199), like the knowledge of related career opportunities (71.1%, n = 199, poor). According to 85.0% of professionals (n = 238) additional postgraduate trainings were needed, mainly university master courses (47.50%, n = 133) and private institution courses (47.86%, n = 134). Postgraduate trainings were considered very useful by 71.4% (n = 200) of responders. Conclusion: Our data suggest undergraduate programs on clinical research education failing at providing even the basic information on clinical research. Therefore, most professionals resort to specific additional postgraduate courses.