International regulators concerned by poor COVID-19 trials, advocate master protocols

Regulators around the world are concerned that small, underpowered and discontinued trials of COVID-19 therapies are crowding out studies that could provide definitive results, according to a readout provided by EMA from a June 12 meeting of the International Coalition of Medicines Regulatory Authorities. The coalition is endorsing the use of master protocols as an efficient tool to quickly produce actionable data.

ICMRA, a voluntary 28 medicines regulatory authorities, is holding biweekly virtual meetings to coordinate global regulatory responses to the COVID-19 pandemic. FDA and EMA are taking turns chairing the meetings. ...