Global regulators commit to cooperate on observational research in the context of COVID-19

EMARegulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring.

High-quality observational research is an important complement to the evidence on the safety and effectiveness of vaccines and treatments for COVID-19 generated in randomised clinical trials. It is critical in understanding the safety and effectiveness of medicines when used in clinical practice for the prevention and treatment of COVID-19.

At a second workshop on observational studies of real-world data generated during clinical practice in the context of COVID-19, co-organised by the European Medicines Agency (EMA) and Health Canada under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) on 19 May 2020, international regulators agreed to step up their cooperation in the following three areas:

  • Pregnancy research to examine the impact of both coronavirus disease and medication use on pregnant women infected with SARS-CoV-2 and on their unborn babies in order to support COVID-19 medicine development, risk management, and planning for safety monitoring of vaccines and therapeutics;
  • Building international clinical cohorts of COVID-19 patients to share expertise and increase study power and data quality in order to meet regulatory requirements and address existing knowledge gaps; and
  • Prepare strong infrastructure for monitoring the safety and effectiveness of vaccines against COVID-19 in order to rapidly detect and minimise risks to patients.

Meeting participants agreed that global collaboration on observational studies of real-world data will help not only to contribute to the COVID-19 response but also to leave enduring legacy for future international observational research beyond the ongoing pandemic.

The meeting built upon the experience and knowledge gained from the first workshop on COVID-19 observational research held in April, which 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. It had participants from more than 25 countries, representing 28 medicines regulatory authorities and experts from the World Health Organization.

The discussion was moderated by Marc Mes, Director General of Marketed Health Products Directorate at Health Canada and Peter Arlett, Head of Data Analytics and Methods Task Force at EMA. More details on discussions and outcomes of the meeting will be shared in the coming days.

Most Popular Now

73,000 Scientists collaborate over new COVID-19 Da…

More than 73,000 users collaborate on new online platform set up by the European Open Science Cloud Initiative, where scientists share COVID-19 data and accelerate our un...

Antiviral used to treat cat coronavirus also works…

Researchers at the University of Alberta are preparing to launch clinical trials of a drug used to cure a deadly disease caused by a coronavirus in cats that they expect ...

Roche and Regeneron collaborate to significantly i…

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Regeneron (NASDAQ: REGN) announced are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV...

Search for COVID-19 drugs boosted by SARS discover…

An extensive search and testing of current drugs and drug-like compounds has revealed compounds previously developed to fight SARS might also work against COVID-19. Us...

Pfizer and BioNTech share positive early data on l…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vac...

Phase I clinical trial initiated for monoclonal an…

The first participants have been dosed in a Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of...

Europe's largest initiative launches to accelerate…

CARE (Corona Accelerated R&D in Europe) a new consortium supported by the Innovative Medicines Initiative (IMI) public-private partnership announced its launch to acceler...

Vitamin D deficiency may raise risk of getting COV…

In a retrospective study of patients tested for COVID-19, researchers at the University of Chicago Medicine found an association between vitamin D deficiency and the like...

Blocking cellular communication stops SARS-CoV-2

In the transmission of signals within the cell which, for example, stimulate cell growth or trigger metabolic processes, phosphate groups play an important biochemical ro...

Improving FDA's COVID-19 vaccine authorization and…

On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of ...

Steroid found to improve survival of critically il…

A new international study published today has shown that treating critically ill patients with COVID-19 with the steroid hydrocortisone improves their chances of recovery...

Bayer and Informed Data Systems Inc. (One Drop) jo…

Bayer and Informed Data Systems Inc. (One Drop), a US-based digital health company, today announced that they have entered into an agreement to jointly develop digital he...