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C OV I D -19 P RO P E LS A D I GI TA L T RI A L RE VOLU T I ON LĂŠon Van Wouwe
COVID-19 impacts all of us significantly. Most notable are the lives lost, the struggling health care services, and the social distancing measures that affect our emotional wellbeing, along with the still unknown impact on the economy. Clinical trials in trouble In the area of clinical research, trial enrollment has dropped massively. A Medidata analysis showed an average reduction in trial enrollment of around 65%, comparing March 2019 and March 2020 (B. Adams, 2020). The pandemic also poses obstacles to ongoing study conduct: lockdowns and social distancing impact compliance with visit schedules and assessments. In the worst case, trial facilities become inaccessible or unsafe, as hospitals are overloaded with COVID-19 patients. Efficacy and safety endpoints may be compromised, as COVID-19 results in excess deaths and complications throughout the study period. This can be especially detrimental to oncology studies, where survival is often a primary endpoint. Supply chain difficulties and availability and access to investigational products pose further challenges (F. Melhem, 2020; GlobalData Healthcare, 2020).
RESEARCH
Challenges drive opportunities Clinical trials are essential to developing new treatments. Remote patient monitoring, home care, and telehealth have been gaining momentum for some time, but COVID-19 is forcing through a (r)evolution in clinical trial execution, from the area of recruitment to that of data submission. COVID-19 research is hungry for immediate access to real-world data in order to gain insights. Digital health technologies that enable continuous real-time data collection meet this need. Across COVID-19 clinical trials, social-distancing measures force the widespread use of virtual connectivity and remote monitoring and management, so we are likely to see a real acceleration in the uptake of new technologies and processes (D. Piekarz, 2020).
