Global regulatory workshop on COVID-19 real-world evidence and observational studies

Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main topics discussed during the 3rd workshop on observational studies of real-world data in the context of COVID-19. The workshop, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), was co-chaired by Health Canada and the European Medicines Agency (EMA) and took place on 22 July 2020. The main findings of the workshop are summarised in a report.

Evidence generated by high-quality observational research is fundamental to understanding the safety and effectiveness of medicines in everyday use by patients and doctors.

Regulators from around the world are working together to enhance global capabilities for observational research during the ongoing COVID-19 pandemic.

Workshop participants discussed the ongoing activities of the three working groups established by the coalition that focus on vaccines surveillance and vigilance, collaboration on pregnancy studies and the building of international cohorts of patients.

The members of the vaccines and surveillance working group provided an update on the development of a COVID-19 pharmacovigilance network to share knowledge, experience and communication on pharmacovigilance planning activities, as well as emerging data on the safety and effectiveness of vaccines, once deployed.

In this context, EMA presented the infrastructure that it has set up to monitor the safety of vaccines when used in day-to-day clinical practice across Europe. The Agency explained some of the projects that are in place to collect data on vaccine coverage in all European countries and to perform a near real-time monitoring of vaccines safety.

The second working group, on the safety of COVID-19 medicines during pregnancy, discussed the necessary steps to build a sustainable worldwide research network of data sources and identify common data models and protocols that will allow to conduct statistical analyses of data in pregnant women across different regions of the world. Meeting participants agreed on the first step of the project, the compilation of a global inventory of ongoing initiatives on this topic.

Regulators also made progress on the discussions regarding the establishment of international cohorts of patients in order to perform large scale observational studies in COVID-19 patients. The working group members agreed on a set of criteria that will inform the selection of research topics to be addressed by this international collaboration.

The meeting built upon the experience and knowledge gained from the previous workshops on COVID-19 observational research held in April and May, where international collaboration and sharing of information between regulators was encouraged. Participants representing 28 medicines regulatory authorities and experts from the World Health Organization attended the workshop.

The discussion was moderated by Sophie Sommerer, Director of Marketed Health Products Directorate at Health Canada and Peter Arlett, Head of Data Analytics and Methods Task Force at EMA.