Advancing international collaboration on COVID-19 real-world evidence and observational studies

News 04/06/2021

Medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation to real-world evidence that can be used to facilitate regulatory decision-making on COVID-19 treatments and vaccines, during a workshop convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The workshop was co-chaired by Health Canada and European Medicines Agency (EMA) and took place on 10 May 2021. The main findings of the workshop are summarised in the report, which has been published today.

Real-world evidence generated by observational studies is fundamental to understanding the benefits and risks of medicines when used in clinical practice for the prevention and treatment of COVID-19. In 2021, the intensive work will continue with a continuous exchange of data on vaccines and methods to achieve a common understanding on the monitoring of their effectiveness and safety.

Meeting participants shared their experiences with using real-world evidence to support decision making in the context of COVID-19. They discussed the main challenges with collecting high-quality real-world data in different countries/regions and exchanged views on approaches to address them. ICMRA members agreed that closer collaboration between regulators worldwide allows timely sharing of data, knowledge and tools, which can benefit patients globally.

The meeting built upon the experience and knowledge gained from the series of ICMRA workshops on COVID-19 observational research held over the last year. Participants representing 28 medicines regulatory authorities and experts from the World Health Organization attended the workshop.

The discussion was moderated by Kelly Robinson, Director General of the Marketed Health Products Directorate at Health Canada and Xavier Kurz, Head of Data Analytics at EMA.

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