Regulatory authorities from around the world intend to cooperate more closely on observational research during COVID-19. To this end, they have identified three areas: Pregnancy research, medicines used in clinical practice, and monitoring the safety and efficacy of vaccines.
Further details on observational research
High-quality observational research is an important complement to the evidence on the safety and efficacy of vaccines and treatments for COVID-19 generated in randomised clinical trials. It is critical to the understanding of the safety and efficacy of medicines and vaccines when used in clinical practice for the prevention and treatment of COVID-19.
At a second workshop on observational studies with real-world evidence data generated during clinical practice in the context of COVID-19, the International Coalition of Medicines Regulatory Authorities 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 the development of COVID-19 treatments, risk management and the safety monitoring of medicines and vaccines;
- Building clinical cohorts of COVID-19 patients to share expertise and increase data quality in order to meet regulatory requirements and address existing knowledge gaps; and
- Prepare strong infrastructure for monitoring the safety and efficacy of vaccines against COVID-19 in order to rapidly detect and minimise risks to patients.
The meeting participants agreed that the increased global collaboration on observational studies with real-world data will help not only to deal with the COVID-19 pandemic, but also to strengthen the future international observational research.
The meeting built upon the experience and knowledge gained from the first workshop on COVID-19 observational research held in April. This had underlined the need for regulators to cooperate and commit to improving information-sharing globally in relation to the research and development of treatments and vaccines against COVID-19. The workshop was attended by participants from more than 25 countries representing 28 medicines regulatory authorities, as well as by experts from the World Health Organisation.
The International Coalition of Medicines Regulatory Authorities (ICMRA) is a global, multilateral initiative involving the heads of medicinal product regulatory authorities. ICMRA promotes inter-authority cooperation on current and emerging human medicine regulatory challenges with the aim of strengthening the quality, safety and efficacy of medicinal products worldwide. Its priorities also extend to coordinated responses to crisis situations in the interests of protecting public health.