Practical approach to the management of clinical studies during the covid-19 emergency in a large academic hospital

Abstract

Background: The Fondazione IRCCS Policlinico San Matteo, the largest academic Hospital in the south-west part of Lombardy has been involved in the management of the COVID-19 outbreak since its inception The emergency required a deep reorganization of our Oncology/ Hematology Clinical trial office (CTO-OH) in order to avoid significant disruption to usual practice, while facilitating clinical trials of the Infectous Disease Unit Materials and Methods: The activity of the CTO-OH included 141 profit and no profit clinical studies before the COVID outbreak In addition to conducting already active clinical studies, several clinical trials with active drugs and procedure towards Covid-19 have been activated through the fast track procedure For all these studies, Sponsor companies and regulatory agencies requested the insertion of data, as the progress of the patients, was monitored in real time to assess their effectiveness, but also any potential damage through the communication of SAE Results: Since February 21st, 2 studies have not been activated at our Institution while 4 were activated through a remote SIV The screening of new patients was reduced and in 2 studies it was temporarily suspended Remote monitoring visits were carried out At the same time the CTO-OH supported the Infectious disease dept and the whole hospital in conducting clinical studies for COVID-19 pts Within a month and half about 100 pts were enrolled, monitored;data were collected and entered A major problem was the management of COVID patients enrolled in the various operative units used for infected patients in which patients were hospitalized or moved following the worsening/ improvement of their conditions We were able to ensure that the staff involved was correctly towed and updated Conclusions: The preparation and experience of the CTO-OH team and the motivation of all the hospital staff involved (physicians, nurses and lab personnel) allowed the success of the COVID-19 studies while almost fully preserving the ordinary Oncology-Hematology activity

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