[CoViD-19: we knew everything but we didn't understand anything.]

Addis, Antonio

The CoViD-19 and its consequences could perhaps have been foreseen. Above all, this pandemic force us to review what is essential and really necessary in term of priorities and regulatory process for clinical pharmacological research. It is evident, among other things, the difficulty to deal with therapeutic uncertainties.Not proven specific therapies are available for the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the cause of CoViD-19), other than supportive care. However, several clinical centres decided to use off label drugs as a standard of care in the absence of efficacy and safety data. The national regulatory body (AIFA) has set up a process in a short time to transparently govern the approval of new trials and to regulate the use of medicines that are not indicated. In this context, the communication of risk associated with experimental therapies was also very important. The lessons we will learn from this emergency may result crucial in redesigning a better way of conducting clinical trials and information on drugs.