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Medicines regulator ‘concerned’ Covid-19 studies are too small

Larger studies are needed to deliver useful results, European Medicines Agency says

The EU’s medicines regulator has warned that research organisations across Europe are undertaking studies of the Covid-19 pandemic that might not deliver useful results because they are too small.

A European Medicines Agency committee is “concerned about the amount of planned small studies or compassionate use programmes across Europe that are unlikely to be able to generate the required level of evidence to allow clear-cut recommendations”, the EMA said in a statement published on 19 March.

“Such studies would not be in the best interests of patients,” it warned.

The EMA urged research organisations to prioritise large randomised controlled clinical trials “because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of Covid-19”.

More international coordination is needed, according to the EMA. All EU countries should be included in the trials, it said, adding that the studies should use standardised methodologies to maximise their usefulness.

The EMA said that speeding the approval of Covid-19 treatments or vaccines was currently its “number one priority”.

The World Health Organization has also recognised the risk of wasting time and effort on inconclusive small trials. On 18 March, WHO director general Tedros Adhanom Ghebreyesus said, “Multiple small trials with different methodologies may not give us the clear, strong evidence we need about which treatments help to save lives.”

In response, the WHO is working with partners in many countries on an international trial to compare several untested potential treatments. “The Solidarity trial provides simplified procedures to enable even hospitals that have been overloaded to participate,” Ghebreyesus said.

The WHO also said on 19 March that it had developed new study methods for testing for the prevalence of Covid-19 in different settings, including one for the general population. “Data from this protocol will provide critical information about the extent of infection…in the general population, age-specific infection cumulative incidence, and the fraction of people with asymptomatic or sub-clinical infection,” the WHO said.

Meanwhile, the League of European Research Universities called on the European Commission to delay application deadlines for health-related research funding calls under the EU’s Horizon 2020 R&D programme by a further two months, saying “potential beneficiaries are currently highly occupied by their clinical jobs and have no time to spare for finalising and submitting their proposal”.