COVID-19 drugs: Regulators join forces on real-world evidence

Article written by Gary Finnegan

Medicines regulators from around the world are collaborating closely on the use of real-world evidence in assessing COVID-19 treatments and vaccines.

During a workshop hosted by the International Coalition of Medicines Regulatory Authorities (ICMRA), regulatory experts discussed the progress made in building international patient cohorts, pregnancy research, and vaccines surveillance and vigilance during the pandemic.

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.

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, according to the EMA which co-chaired the event with Health Canada.  

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.