1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

More from R&D

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 
• By Eliza Slawther

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.

Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.