Observational studies of data generated in clinical practice in the context of COVID-19 can contribute to the development, authorisation and monitoring of the safety and efficacy of medicines and vaccines to prevent and treat COVID-19. Closer collaboration between international medicines regulators and information sharing in this area will benefit patients around the world. This is highlighted in the summary of the latest global regulatory workshop on COVID-19 observational studies and real world data, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), which has been published today.

The meeting report provides a snapshot of ongoing or planned observational studies, platforms and registries in various countries and regions around the world. The studies are aimed to characterise COVID-19 disease and identify links between clinical outcomes and the use of potential treatments for COVID-19 and of concomitant medication, such as angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor antagonists (ARBs) and non-steroidal anti-inflammatory medicines (NSAIDs). Observational studies also have the potential to generate robust evidence on the safety and effectiveness of vaccines and treatments when they are released on the market.

There is broad agreement that the large number of studies on the effects of ACE inhibitors and ARBs in people with COVID-19 in different countries, for example, shows the need for coordination of research priorities and study planning. Sharing of protocols and results is a critical aspect of the global approach, in view of the rapidly evolving research questions on COVID-19 treatments and the multiple research groups addressing them.

Workshop participants also identified suitable platforms for sharing information about COVID-19 observational research and results. In addition to the publication of observational studies on international websites (such as the EU PAS Register or ClinicalTrials.gov) and national databases, research questions, protocols as well as potential challenges will be discussed by regulators in future ICMRA teleconferences on observational studies.

Posted on the EMA website on 16 April 2020