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Covid, the digital revolution is underway. new horizons for clinical trials

Daniele Zago

Explosion in digital health: The Covid emergency has opened the floodgates to a digital revolution in all sectors of healthcare and wellness. An acceleration that now needs to be managed, governed, taking full advantage of the opportunities and minimizing the 'side effects'. 'Digital health' encompasses the monitoring of one's own health through the tools - such as the applications, the supports that detect patient data - that are more accessible today than ever before. Innovation in clinical trials and value-based outcomes: The digital revolution underway and driven by Covid confronts us with substantially new opportunities and challenges. A mass of health-related and behavioral data that must be validated on the basis of clear and certified parameters. Just think that even the simple application that we download to our phone, obviously linked to the monitoring of specific health parameters, is in all respects a 'medical device'. Knowing this standard is fundamental today, when we consider the increasing demand for value- based evidence for digital devices, connected devices and digital therapeutics, and the new modalities for virtual trials and real-world evidence. New horizons for the healthcare system and society: Obviously, all this brings with it the need to inform and train healthcare professionals who deal with biotechnologies and digital health data, as well as patients and regulators. From nurses to professionals in the clinical research sector, from those who offer 'social' services - but in an increasingly innovative way - to doctors. Tools, standards, specific qualities of the professional. In this sense, the virus is a testbed and an opportunity to reach tools that only yesterday seemed blocked, stranded by the absence of a real need which today has emerged in all its evidence. In this phase of global crisis that has affected all of us, the entire scientific and academic community needs to devote programs and resources to support the healthcare community, the patients and society, creating dedicated training programs, in every country all over the world.