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

Swissmedic begins rolling review of Moderna's mRNA…

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for...

Moderna's COVID-19 vaccine candidate meets its pri…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for...

Pfizer and BioNTech conclude Phase 3 study of COV…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based...

Pfizer and BioNTech to submit Emergency Use Author…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authori...

Phase 2 trial of Oxford COVID-19 vaccine in health…

The UK's vaccine against SARS-CoV-2 shows similar safety and immunogenicity results in healthy older adults (aged 56 years and over) to those seen in adults aged 18-55 ye...

Lilly's neutralizing antibody bamlanivimab (LY-CoV…

The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Eli Lilly and Company's (NYSE: LLY) investigational neutralizing antibody bamlan...

Chinese vaccine candidate based on inactivated SAR…

Results from an early-phase randomised clinical trial of a Chinese vaccine candidate based on the inactivated whole SARS-CoV-2 virus (CoronaVac) are published in The Lanc...

Medicago and GSK announce start of Phase 2/3 clini…

Medicago, a biopharmaceutical company headquartered in Quebec City, and GSK have announced the start of Phase 2/3 clinical trials of its plant-derived vaccine candidate f...

European Commission approves contract with BioNTec…

Today, the European Commission approved a fourth contract with pharmaceutical companies BioNTech and Pfizer, which provides for the initial purchase of 200 million doses ...

Pre-existing coronavirus antibodies could help pro…

Researchers at the Francis Crick Institute and University College London have found that some antibodies, created by the immune system during infection with common cold c...

Fluvoxamine may prevent serious illness in COVID-1…

In a preliminary study of COVID-19 patients with mild-to-moderate disease who were attempting to recover in their homes, researchers at Washington University School of Me...

The Sputnik V COVID-19 vaccine efficacy amounted t…

The National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of the Russian Federation (Gamaleya Center) and the Rus...