1. Pink Sheet
  2. >>Vaccines

After First COVID-19 Vaccine Approval, How Will Other Trials Maintain Placebo Control?

 
• By Derrick Gingery

US FDA officials fear comparator arms would be unwieldy for ongoing trials as they consider alternative methods to measure efficacy if placebo controls can't be maintained for the studies of other candidate vaccines once a product is on the market.

Antibodies immunoglobulins attacking coronavirus covid-19 influenza virus cell, 3D immune system medical illustration background. Corona virus 2019-ncov sars cell, igm. Coronavirus sars-cov-2 disease
Alternative statistical approaches may be possible if placebo controls cannot be maintained. • Source: Shutterstock

US Food and Drug Administration officials are thinking about ways to ensure the randomized, placebo-controlled Phase III clinical trials for coronavirus vaccine candidates can continue even after a product successfully completes the regulatory process.

Once the FDA approves or grants an emergency use authorization to make a vaccine available, trial enrollment may become much more difficult and those already enrolled may

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 Vaccines

More from Pink Sheet

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.