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

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

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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...

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