For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, and collaboration between researchers, to ensure high-quality, powerful studies. High-quality observational research of real world data collected during the pandemic can be an important complement to the results of randomised clinical trials in providing evidence on the safety and effectiveness of vaccines and treatments for COVID-19. Such research is also critical to understand how exposure to certain medicines can affect the risk or the severity of infection with the virus.
There are many ongoing observational studies by different research groups globally looking into these aspects, and there will be more in the coming months. However, to generate evidence upon which decisions can be based, observational studies of real world data must be well-designed and adequately powered (i.e. based on large populations).
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