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Global regulators discuss observational studies of real world data for COVID-19 medicines

In a dedicated COVID-19 workshop convened on 6 April under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed how data generated during clinical practice could complement evidence from clinical trials with potential therapeutics or vaccines against COVID-19. Participants from more than 25 countries, representing 28 medicines regulatory authorities globally and experts from the World Health Organization and the European Commission acknowledged the importance of observational studies of real world data for increasing the effectiveness and efficiency of regulatory processes and decision-making in the development, authorisation and monitoring of medicines and vaccines to prevent and treat COVID-19 and to address knowledge gaps that cannot be addressed by clinical trials. 

Delegates from medicines regulatory authorities shared insights into ongoing and planned COVID-19 observational studies aimed at characterising the disease and generating robust evidence on COVID-19 vaccines and therapeutics. They discussed observational studies in different countries and exchanged practical information about research questions, protocols and procedures to ensure the reliability of results needed to meet regulatory requirements. Sharing of protocols and results was identified as a critical aspect of the global approach. Participants also discussed the suitability of existing platforms for doing this.

The workshop was co-chaired by Health Canada and EMA. It was the latest in ICMRA’s series of virtual COVID-19 workshops held in March and April. Each session focused on a specific area where medicines regulatory authorities have a role to play in the response to the ongoing pandemic.

These workshops underline the commitment of regulators to cooperate and improve information-sharing globally in relation to the research and development of treatments and vaccines against COVID-19.

The two previous workshops dealt with COVID-19 vaccine development, and on potential therapeutics, clinical trials and compassionate use programmes.

The discussion on observational studies of real world data was moderated by Marc Mes, Director General of Marketed Health Products Directorate at Health Canada and Peter Arlett, Head of EMA’s Data Analytics and Methods Task Force.


Summary report