The European Commission and the European Medicines Agency (EMA) support the development and approval of vaccines and treatments for COVID-19 under its plan for managing this current health threat.
Consult the EMA's special coronavirus disease (COVID-19) website for frequent updates.
Researchers are encouraged to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register, including a study protocol and description of the collected data. The term "COVID-19" should be included in the title to allow others to easily retrieve it.
Link to the EU PAS Register
SOLIDARITY is an international clinical trial to help find an effective treatment for COVID-19 that was launched by the World Health Organization (WHO) and its partners. It is one of the largest international randomised trials for COVID-19 treatments, with an enrolment of almost 12,000 patients at 500 hospital sites in over 30 countries.
The WHO published the first interim results of the SOLIDARITY trial on 15 October 2020. The results are under review for publication in a medical journal and have been uploaded as a preprint.
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The European Forum for Good Clinical Practice (EFGCP) provides a very comprehensive repository of recommendations and guidances from regulatory authorities and others concerning clinical trials related to COVID-19.
Linkt to the EFGCP-AWP Covid-19 Repository
The Clinical Research Metadata Repository makes it possible to find clinical studies and related data objects, for example protocols, information sheets and consent forms, data management plans, statistical analysis plans, case report forms, results, publications, and descriptive metadata. It is freely available to all scientific researchers working in clinical research, and especially for those working on COVID-19. The system is updated regularly by collecting data from the most important sources of information worldwide – from New Zealand to the Netherlands and from Japan to Lebanon. The current Clinical Research Metadata Repository is the third beta release of the platform; ECRIN updates the content of the platform regularly, and continues to work on newer releases.
COVID-evidence is a non-profit database with the evidence available worldwide on interventions for the prevention and treatment of COVID-19. This expanded database is continuously updated and freely available. It provides information about worldwide planned, ongoing, and completed trials worldwide on any intervention to treat or prevent SARS-CoV-2-infections. It combines automatic search strategies with expert manual extraction of key trial characteristics performed in duplicate.
Link to COVID-evidence.org
During the COVID-19 pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) has been acting as a forum to support strategic coordination and international cooperation among global medicine regulatory authorities. The aim of these activities is to expedite and streamline the development, authorisation, and availability of COVID-19 treatments and vaccines worldwide. ICMRA members also work towards increasing the efficiency and effectiveness of regulatory processes and decision-making.
Swissmedic, the Swiss authority responsible for the authorisation and supervision of therapeutic products, is a member and supports the coalition’s activities in various working groups.
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Updated on 9 November 2020
Photo by CDC on Unsplash
