Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data

News 16/04/2020

Observational studies of data generated in clinical practice in the context of COVID-19 can contribute to the development, authorisation and monitoring of the safety and efficacy of medicines and vaccines to prevent and treat COVID-19. Closer collaboration between international medicines regulators and information sharing in this area will benefit patients around the world. This is highlighted in the summary of the latest global regulatory workshop on COVID-19 observational studies and real world data, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), which has been published today.

The meeting report provides a snapshot of ongoing or planned observational studies, platforms and registries in various countries and regions around the world. The studies are aimed to characterise COVID-19 disease and identify links between clinical outcomes and the use of potential treatments for COVID-19 and of concomitant medication, such as angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor antagonists (ARBs) and non-steroidal anti-inflammatory medicines (NSAIDs). Observational studies also have the potential to generate robust evidence on the safety and effectiveness of vaccines and treatments when they are released on the market.

There is broad agreement that the large number of studies on the effects of ACE inhibitors and ARBs in people with COVID-19 in different countries, for example, shows the need for coordination of research priorities and study planning. Sharing of protocols and results is a critical aspect of the global approach, in view of the rapidly evolving research questions on COVID-19 treatments and the multiple research groups addressing them.

Workshop participants also identified suitable platforms for sharing information about COVID-19 observational research and results. In addition to the publication of observational studies on international websites (such as the EU PAS Register or ClinicalTrials.gov) and national databases, research questions, protocols as well as potential challenges will be discussed by regulators in future ICMRA teleconferences on observational studies.

About the workshop

The workshop was held virtually on 6 April 2020. It was attended by representatives from 28 medicines regulatory authorities globally and experts from the World Health Organization to discuss how data generated during clinical practice could complement evidence from clinical trials of potential therapeutics or vaccines against COVID-19. The meeting 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.

ICMRA will build on the knowledge and experience gained from the series of workshops on COVID-19 medicine development and will continue dialogue with global regulators through various forums.

Notes

ACE inhibitors and ARBs are most commonly used for treating patients with high blood pressure, heart failure or kidney disease.

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