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

Woodcock Warns Research Apparatus Could Be Overwhelmed If Coronavirus Trials Don’t Use Master Protocols

 
• By Derrick Gingery

CDER Director Janet Woodcock says researchers need to embrace pragmatic trial designs and compare multiple treatments at the same time rather than employ separate development programs.

Coronavirus globe
CDER Director Janet Woodcock said master protocols could help assess repurposed drugs faster. • Source: Shutterstock

Sponsors soon may have no choice but to develop master protocols and similar trial designs for coronavirus treatments, as there now are concerns there may not be enough researchers to handle the workload.

Janet Woodcock, director of the US Food and Drug Administration’s Center for Drug Evaluation and Research, said on 23 April that the nearly 1,000 inquiries and proposals for coronavirus treatments...

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

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

More from R&D

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.