Rethinking What To Call The ‘Real World’

Stakeholders suggest a host of alternatives to what they see as the US FDA’s poor choice of words to describe studies intended to reflect actual clinical practice.

dictionary-thesaurus
The US FDA may want to rethink the terminology it uses for real-world studies. • Source: Shutterstock

The US Food and Drug Administration's terminology around real-world data and evidence is not going over well in the real world.

At the recent meeting Duke-Margolis Center for Health Policy meeting on leveraging randomized trials to generate RWE, stakeholders suggested 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

More from Clinical Trials

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By 

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

More from R&D

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By 

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.