Clinical research methodology process: what has changed with COVID-19?

Abstract

The immediate repercussions of the pandemic on clinical research were the systematic interruption of ongoing studies and the explosion of tens of thousands of anti-COVID-19 research protocols reported in fragmented, uncoordinated, often technically insufficient international registers, from which almost nothing of significance was produced. In the first two years of intensive research, anti-inflammatory and anticoagulant benefits were identified, while the systemic nature of the viral disease was clearly manifested, but no specific antiviral drugs emerged. Subsequently, monoclonal antibodies and antiviral drugs such as Ritonavir-Boosted Nirmatrelvir (Paxlovid) have given way to more specific therapies, even if surprisingly little used. Finally, the new national Electronic Health Record (EHR-FSE2 Fascicolo Sanitario Elettronico 2 in Italian) was approved as a law, which will integrate the previous one, which is in fact not functional. The systematic, orderly and complete collection of the health data of each citizen constitutes a radical modification of the current National Health System, epidemiology and clinical research.