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For COVID, Consensus On Value Of Platform Trials, But A Confusion Of Consortia

 
• By Bridget Silverman

The coronavirus pandemic could be a turning point for master protocol and platform trial designs, but clear guidance and coordination are still needed.

Image of business partners hands on top of each other symbolizing companionship and unity
Master protocols are a cornerstone of the “critical path” for COVID-19 therapeutics proposed by a recent Duke-Margolis Center paper. • Source: Shutterstock

Two former US Food and Drug Administration commissioners – Mark McClellan and Scott Gottlieb – are among the most recent regulatory experts to join the international chorus calling for master protocols and platform trials to streamline evaluation of the vast but chaotic pipeline of COVID-19 treatment and vaccine candidates. The ex-commissioners also note the need for “clear regulatory guidance” to leverage the potential of such trial designs.

Master protocols are a cornerstone of the “critical path” for COVID-19 therapeutics proposed in a 20 May paper from the Duke-Margolis Center for Health Policy, which outlines a “hyper-parallel path for promising therapeutics that replaces and augments the usual highly sequential development process

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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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