International – 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…