Revolutionizing Clinical Trial Units In The Pandemic Era

Background: COVID-19 pandemic has impacted all health care areas, including clinical research, especially in the countries most affected by the emergency, such as Italy This forced a profound reorganization of experimental sites and Clinical Trials Units (CTU), in accordance with the specific guidelines gradually drawn up by the regulatory agencies Methods: In April 2020 the Italian Group of Clinical Research Coordinators spread an anonymous web survey consisted of 21 questions about the reorganization of CTUs and the managements of trials since the start of pandemic Results: 142 representatives of Italian CTUs completed the survey;women was 86% and the age group 26-35 years was the mainly represented (50 7%) A total of 15 on 21 Italian regions were represented with a good national coverage The majority of respondents (85 2%) said that, due to the emergency, the CTU activity has been reorganized, mainly through the alternation of smart working and shifts on site (64 5%) or the activation of a totally smart working method (27 3%) Within the cohort that had the opportunity to work, partially or totally, from home (81 7%), most respondents (69 8%) stated they benefited from a high level of accessibility to hospital records, in many cases (50 6%) both patient records and shared document areas In very few cases, the employer has provided additional tools for staff, such as PCs (15 5%) or phones (0 9%) company, while many respondents (49 1%) said they had not even received assistance from their IT service With regard to the opinion on the effectiveness of the smart working activity,the average score was 6 3 on a scale of about 1–10 Conclusions: Most of the Clinical Trials Units have been reorganized so that deferred activities can be carried out away from the hospital, guaranteeing, on average, wide remote access to the necessary documentation Certainly, it would be necessary to improve the IT and electronic equipment that employees benefit from so as to optimize all activities and ensure rapid and high-quality performances, even in non-emergency situations Clinical trial identification: The authors Legal entity responsible for the study: Gruppo Italiano Data Manager Funding: Has not received any funding Disclosure: All authors have declared no conflicts of interest