EMA calls to scale up COVID-19 trials for conclusive data

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/ra2studio)
(Image: Getty/ra2studio)

Related tags: European medicines agency

The agency says the industry should prioritize large randomized controlled studies developing COVID-19 treatments, to acquire robust data.

In an announcement released on Thursday, following up from previous updates​ on the fight against the COVID-19 pandemic, the European Medicines Agency (EMA) urged the clinical research industry to prioritize large randomized controlled studies.

The regulatory agency’s Human Medicines Committee (CHMP) suggests that these studies are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments for the disease.

A ‘harmonized approach’ to data collection while the race to develop a treatment for COVID-19 is in place will enable the industry to make best use of the available supply of investigational agents, suggest the EMA, calling researchers to include all countries of the European Union (EU) in the ongoing trials.

According to the regulator, “clinical trials with a small number of participants or compassionate use programs might not generate the data required to draw firm conclusions on the effects of a given therapeutic and give appropriate advice to healthcare professionals and patients.”

Moreover, the EMA stated that it is in talks with stakeholders able to potentially offer further support to the ongoing research, and that developers will be provided with “all available regulatory tools”​ to expedite their development projects.

Researchers with development proposals are encouraged to contact the regulatory body, while EU member states are called to report any emerging information on investigational agents to the EMA.

In an announcement last week, the EMA outlined the as-yet developments of the pandemic​, and stated that it would participate in the European Commission’s advisory panel​ on the virus outbreak.

Earlier this month, the European regulator stated that it has formed an Executive Steering Group responsible to monitor and address the impact of the outbreak on the regional supply chain of medicines​.

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