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The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective.
A comprehensive, international coordinated effort to conduct adequate and randomized controlled trials is necessary to “generate sound evidence on the effects of therapeutics or vaccines against COVID-19,” says the European Medicines Agency (EMA). The agency is concerned that stand-alone clinical trials that have small numbers of participants might not generate enough data in which to make informed regulatory decisions on. It has, therefore, published an article that details actions stakeholders should take to generate “conclusive evidence” to develop potential treatments and vaccines for COVID-19.
The actions that stakeholders involved with COVID-19 clinical trials should take, according to EMA, include the following:
International regulatory agencies are working together under the International Coalition of Medicines Regulatory Authorities (ICMRA) to expedite and streamline the development of COVID-19 vaccines and treatments. The ICMRA held meetings in March and April 2020 to exchange information about regulatory issues and clinical trials and to align international approaches to development of COVID-19 treatments.