Oncology Clinical Trials management during the pandemic-the Italian experience

Background: COVID-19 pandemic, caused by the new SARS-COV-2 virus, has impacted all Italian healthcare areas, including clinical research This forced a profound reorganization of experimental sites, including the activities of Clinical Trials Units (CTU) Moreover, in March 2020 the Italian Medicines Agency (AIFA) provided guidance on the management of clinical trials in light of the restrictive measures adopted by the Government against the pandemic Methods: We decided to investigate how the Italian CTUs have reorganized and how smart working is considered truly effective during the emergency In April 2020 all members of Italian Group of Clinical Research Coordinators were invited to complete a web survey, consisted of 21 questions about the reorganization of CTUs and the managements of trials since the start of pandemic Results: 142 research professionals completed the survey: 120 Clinical research Coordinators, 21 data managers and 1 biostatistician Women was 86% (n=122) and the age group 26-35ys was the mainly represented (n=72, 50 7%) A total of 15 on 21 Italian regions were represented with a good national coverage The majority of respondents (n=121, 85 2%) said that, due to the emergency, their activities were reorganized, mainly through the alternation of smart working and shifts on site (n= 78, 64 5%) or the activation of a totally smart working method (n=33;27 3%) Within the cohort that had the opportunity to work, partially or totally, from home (n=116, 81 7%), most respondents (n=81, 69 8%) stated they benefited from a high level of accessibility to hospital records, in many cases (n= 41, 50 6%) both patient records and shared document areas In very few cases, the employer has provided additional tools for staff, such as PCs (n=18, 15 5%) or phones (n=1, 0 9%) company while many respondents (n=57, 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 Conclusion: 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