Strengthening global collaboration on COVID-19 real-world evidence and observational studies

Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence 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 the European Medicines Agency (EMA) and took place on 13 October 2020. Participants discussed the progress made in building international patient cohorts, pregnancy research, and vaccines surveillance and vigilance during the pandemic. The outcomes of the discussions are highlighted in the summary report, which has been published today.

Observational research can complement the knowledge gained through clinical trials to support the evaluation of potential therapeutics and vaccines against COVID-19. 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.

Workshop participants shared their lessons learnt from ongoing COVID-19 observational studies based on real-world data in various countries and regions around the world. Studies derived from such data can provide information that is critical to understanding the benefits and risks of medicines in real-life use by patients and healthcare professionals. Closer collaboration between international regulators and information sharing in this area will benefit patients globally.

The meeting built upon the experience and knowledge gained from the previous three ICMRA workshops on COVID-19 observational studies held in April, May and July. It underlined the need and commitment by regulators to cooperate and improve information-sharing globally in relation to the research and development of treatments and vaccines against COVID-19. 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.