The European Medicines Agency (EMA) has called for transparency for protocols and results, and collaboration between researchers, in observational real-world studies of COVID-19 and has established a COVID-19 response group to facilitate collaboration between researchers across the world.
In a statement, the EMA said there are many ongoing observational studies underway globally and there will be more in the coming months. However, the agency said, to generate evidence upon which decisions can be based, observational studies of real-world data must be well-designed and adequately powered.
When planning observational studies, researchers should adhere to existing guidelines on the appropriate design and conduct of pharmacoepidemiological studies, including the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) guide on methodological standards in pharmaco-epidemiology. The EMA also reminded researchers to post all protocols and reports of observational COVID-19 studies in the EU Post-Authorisation Studies (PAS) register to ensure transparency and scrutiny of study design and results.
An EMA-ENCePP COVID-19 response group has also been established to facilitate collaboration between researchers to improve the size and methodological rigour of studies, maximising their contribution to knowledge about the use of medicines in COVID-19.