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

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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.

The June 12 ICMRA COVID-19 discussion was moderated by Janet Woodcock. Woodcock recently temporarily stepped away from her position as director of FDA’s Center for Drug Evaluation and Research to head up therapeutics development for the U.S. government’s Operation Warp Speed (see “Woodcock Steps Away from CDER for Operation Warp Speed”).

At the meeting regulators “shared concerns about the discontinuation of clinical trials globally and the growing number of underpowered studies that might not generate the robust data required for regulatory decision-making,” EMA said.

ICMRA members called on investigators to continue clinical trials that might produce conclusive evidence, provided that trial participants’ safety is ensured.

In addition, they “reiterated that the research community should pool resources into large, well-designed, randomised clinical trials to determine which investigational or repurposed medicines would be safe and effective for the treatment or prevention of COVID-19.”

ICMRA members are compiling lists of ongoing and planned clinical COVID-19 trials with master protocols in different countries and regions to compare the protocols and identify overlaps. They plan to update the lists on a regular basis.

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