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EMA calls for pooled EU research into COVID-19 therapies

Asks for a harmonised methodology across member states

Clinical development

With Europe now declared the epicentre of the COVID-19 pandemic by the World Health Organization (WHO), the European Medicines Agency (EMA) has called for a harmonised methodology for data collection across the continent.

The EMA has called for all EU member states to pool their research resources into “large-scale, multi-centre, multi-arm clinical trials against COVID-19”, the disease caused by the novel coronavirus.

The agency’s Committee for Medicinal Products for Human Use (CHMP) is aware of a number of planned investigational studies to treat patients under compassionate use or similar protocols with investigational drugs.

In response, the CHMP has deemed it ‘critical’ to the successful development of COVID-19 treatments that any data generated from these studies shows robust efficacy, to support their eventual wide-scale use.

That means that randomised controlled studies, with a control, placebo arm, must be encouraged to allow for the production of data that can be easily interpreted by regulatory authorities, and provide healthcare professionals with the information needed to select the best treatments for COVID-19.

The EMA's concern with these individual, planned small studies is that the data produced would not have the same clarity of efficacy against the disease and "would not be in the best interests of patients”.

The EMA is also calling for a broader inclusion in the studies, as although the highest risk groups are older adults with cardiovascular or respiratory health issues, children are also known to be affected.

As such, at least adolescent-aged candidates should be considered for inclusion in the studies, the agency has maintained.

As the coronavirus outbreak situation continues to evolve across the continent, the EMA has been at the centre of providing accurate information and coordinating research efforts.

That includes initiating the first global regulatory workshop on COVID-19, under the International Coalition of Medicines Regulatory Authorities (ICMRA).

The virtual meeting, which took place with delegates from 17 countries representing over 20 medicines regulatory agencies across the world, discussed the development of COVID-19 vaccine candidates.

The EMA also provided advice on the use of anti-inflammatories such as ibuprofen against the disease yesterday, after reports that the medicine could worsen the effects of COVID-19 emerged from a number of reports.

It has advised that while there is no scientific evidence that ibuprofen worsens the disease, it is closely monitoring the situation and will review information as and when it becomes available.

Article by
Lucy Parsons

19th March 2020

From: Research

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