International Coordination on COVID-19 Treatments Necessary, Says EMA

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:

• The research community should consider whether their planned trial can become part of a larger platform.

• Developers should to seek interactions with regulators as early as possible.

• Stakeholders should support well-established public or private consortia to ramp up their activities and take on a wider role in the management of trials.

• There should be regulatory flexibility while ensuring quality, efficacy, and safety of medicines.

• Ethics committees should evaluate if the benefits of conducting a stand-alone clinical trial outweighs risks and burdens to the participants.

• An infrastructure to support clinical trial conduct should be established.

• Patient organizations and learned societies should be used to encourage clinical trial coordination.

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.

Source: EMA