EMA calls for researchers to pool resources, conduct large RCTs for COVID-19 therapies
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On Thursday, EMA's CHMP called on European researchers to pool resources and coordinate large, multi-country clinical trials of COVID-19 candidates in order to generate enough data for the European regulator to draw conclusions on efficacy.
"The CHMP 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 agency said in a statement.
CHMP said researchers and companies should prioritize the design and execution of large randomized controlled trials with a control arm that lacks antiviral therapy to better characterize the efficacy of either new or repurposed agents. The agency said it is engaging with stakeholders to better coordinate and support the design of such trials across the EU.
The plea to industry and academics comes one day after WHO launched its master protocol SOLIDARITY trial to address the same concerns regarding insufficient evidence from multiple small trials (see “WHO Launching Master Protocol for COVID-19 Therapies”).
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