1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials
  4. >>Real-World Evidence

EMA, HTA Bodies & Payers Explore Common Ground On Use Of RWE

 
• By Vibha Sharma

A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment bodies and payers. 

Electronic medical record with HEALTH inscription, Medical technology concept
Analysis of RWD databases can provide valuable information to support regulatory and reimbursement decisions • Source: Alamy

The European Medicines Agency is working with representatives of EU health technology assessment (HTA) bodies and payers to identify situations where the use of real-world evidence (RWE) might be of interest to all three of them to support their respective decision-making functions.

Once RWE “use cases” that are common to the regulators, HTA bodies and payers are identified, the plan is to...

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 Real-World Evidence

MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 
• By Eliza Slawther

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.

EMA Tackles Guidance Void As Proposals For External Controls Grow

 
• By Neena Brizmohun

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

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.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from Clinical Trials

AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

EMA Tackles Guidance Void As Proposals For External Controls Grow

 
• By Neena Brizmohun

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.