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Regulatory Focus™ > News Articles > 2020 > 7 > Global regulators agree on endpoints for COVID-19 therapeutics

Global regulators agree on endpoints for COVID-19 therapeutics

Posted 31 July 2020 | By Michael Mezher 

Global regulators agree on endpoints for COVID-19 therapeutics

Regulators participating in the International Coalition of Medicines Regulatory Authorities (ICMRA) last week reached a consensus on endpoints that would be acceptable as primary endpoints in randomized controlled trials for therapeutics to treat coronavirus disease (COVID-19).
In a teleconference on 20 July 2020 co-chaired by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), ICMRA members reviewed potential endpoints with the goal of agreeing on acceptable endpoints that could “facilitate rapid and consistent implementation of future clinical trials for COVID-19 medicines across the world.”
According to the regulators, “The primary endpoint ideally should be clinically meaningful (capturing patient function as well as survival), but also it needs to be measurable, to be sufficiently sensitive to allow realistic sample sizes.” Sponsors should also define how they will handle missing data, intercurrent events and mortality in their studies.
For hospitalized patients with moderate or severe COVID-19, the regulators put forth a range of acceptable primary endpoints to both inform clinical benefit and support regulatory decision-making. The endpoints include time to recovery through day 28/29, clinical status as improvement of two points on an ordinal scale, mortality within 28 days after randomization and time to sustained recovery up to day 90.
Despite supporting a range of potential endpoints, the regulators said that mortality, “Should be collected as a key secondary endpoint in all studies that don’t plan to use this outcome as primary.” The regulators also discussed other endpoints, including progression of disease, number of days not on a ventilator and recovery rates, but did not reach a consensus as to their acceptability.
For studies of patients with mild cases of COVID-19 in outpatient settings, the regulators agreed that mortality “may not be suitable” as a primary endpoint. Other endpoints, including rate of progression to severe disease or proportion of patients not hospitalized at a prespecified time point, may be appropriate based on the study objective.
While the regulators agreed that virological endpoints “could be useful for proof-of-concept studies,” they note that the primary endpoint for Phase 3 studies should reflect the primary study objective.
The regulators also note that the changes in the standard of care for treatment of COVID-19 must be considered when designing future studies.

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