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Real-World Data Can Include EUA Observations, US FDA Final Guidance Says

 
• By Bridget Silverman

Agency clarifies expectations for non-interventional studies providing RWD to support regulatory decisions while continuing to emphasize familiar themes around early interaction and stringent data practices.

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An explicit statement that data collected from clinical practice with products available under an emergency use authorization (EUA) can be considered in the scope of real-word data is one of the clarifications made by the US FDA in its final guidance on “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.”

The final guidance published 31 August 2023 edits and clarifies the draft version issued on 9 December 2021 as part...

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Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
• By Bridget Silverman

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.

Cancer Drug Combos: US FDA Guidance Offers Options Beyond Factorial Trials

 
• By Manas Mishra

Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.

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.

More from Clinical Trials

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
• By Jung Won Shin

Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.

Denmark Tackles GCP Inspection Pain Point: Lack Of Direct Access To Patient Records

 
• By Vibha Sharma

Despite being a longstanding requirement under EU and international regulations, the Danish Medicines Agency says its good clinical practice inspectors frequently encounter cases where sponsor-appointed clinical trial monitors are denied direct access to patient records.

UK To Formalize ‘Research As Care’ Concept To Boost Clinical Trial Participation

 
• By Vibha Sharma

The UK’s Health Research Authority has issued a report addressing the legal, policy, and ethical questions around who can access confidential patient information to identify potential participants for clinical trials.