EMA calls on EU to pool resources together to carry out large scale clinical trials against COVID-19

pharmafile | March 19, 2020 | News story | Business Services COVID-19, Chinese Coronavirus, Wuhan Coronavirus, coronavirus 

The European Medicines Agency (EMA) has called on the European Union to collaborate closely on carrying out clinical trials on treatments and vaccines to combat the COVID-19 coronavirus.

In a statement the EMA said that: “It is essential that Member States in Europe implement a harmonized and robust methodology for data collection.”

Several academic institutions and hospitals in Europe are preparing to test treatments. However, the Committee for Medicinal Products of Human Use (CHMP) has emphasized the need to work together. They believe a control arm for each individual study would not be able to generate the amount of evidence required to allow clear cut recommendations of treatments for coronavirus.

The CHMP recommends multi-arm clinical trials across states to investigate different agents simultaneously which will have the potential to deliver results as rapidly across a range of therapeutic options based on the same evaluation criteria.

In closing, the EMA said in its statement: “It is therefore strongly recommended that a more coordinated approach across the EU is pursued and that efforts are put in place to prioritise larger multi-country randomised clinical trials (RCTs) that have the potential to generate confirmatory evidence.”

The EMA also says it is engaging with different stakeholders and can support clinical trial sites in member states with study sponsors.

This call for closer collaboration comes as health experts in the UK warn about the impact its leaving the EU and breaking with the EMA will do to accessing coronavirus treatments. Experts warn that the lack of collaboration and adherence to similar regulations will put them at the back of a queue to access a vaccine.

Conor Kavanagh


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