At the outbreak of the severe acute respiratory syndrome coronavirus 2 epidemic in Italy, non–peer-reviewed articles and press releases of small clinical trials, including the overall amplification and uncritical reporting of «potential cures, led physicians to use many drugs off the label with high expectations of their potential benefit. Of these, 40 had been approved, 10 had been suspended for further clarifications, 92 had been rejected, and a couple was under evaluation.
The centralized procedure allowed AIFA to use the clinical test approval pathway to strengthen the pivotal role played by best available evidence, inform clinical practice, and support emergency governance. For this reason, AIFA nudged clinicians and therefore the research community to submit an RCT of tocilizumab versus standard of care, and that was approved 2 weeks later. The second example of the transition from emergency management to informative clinical trials is given by chloroquine and lopinavir-ritonavir, which were initially defined as control groups or SoC in most clinical trials. The agency also issued a warning against the routine use of a number of these drugs and their combinations except in clinical trials, thus bridging clinical studies and clinical practice.
In conclusion, evidence-informed prescribing and clinical trials were beaten off the mark by social media, rumors, and panic within the early phase of the COVID-19 pandemic, triggered by the shortage of therapeutic options within the treatment of a rapidly spreading and severe disease.
Ref: https://www.acpjournals.org/doi/10.7326/M20-3775
