The scale, severity and novelty of the COVID-19 pandemic raise many questions on clinical features, risk factors and treatments of COVID-19 infections. This creates unprecedented challenges for the epidemiological and regulatory communities:
• Need for data supporting regulatory decision-making and covering disease epidemiology, risk factors for infection and its severity, safety and effectiveness of treatments repurposed to COVID19 indication, and in the future safety and effectiveness of new treatments and vaccines; the need for data may involve getting access to specific data sources.
• Need for collaborations to design and perform high quality observational studies with regulatory impact, based on large populations and use of best methodological standards.
• Need for expertise to develop (or identify) and disseminate appropriate methods for the study of COVID-19 medicines-related issues; expertise may be needed in a large variety of domains such as pharmacogenomics, infectious diseases, genetic epidemiology, pharmaco-epidemiology, clinical pharmacology, and pharmacovigilance…