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EMA Dismisses Claims That RWD Is The ‘Wrong Remedy’ For Drug Development Challenges

 
• By Neena Brizmohun

The European Medicines Agency has responded to an analysis that argued that generating evidence for decision making in health care using observational real-world data, and thus potentially replacing randomized controlled trials, “is the wrong remedy for the challenges in drug development.”

drug approval
The EMA says medicines evaluation and regulatory decision making considers all available evidence and its strengths and limitations • Source: Shutterstock

The European Medicines Agency has taken issue with an analysis published in the British Medical Journal that questioned the growing enthusiasm for the use of observational real-world data (RWD) as a basis for regulatory, clinical and health policy decision making.

The analysis, by authors from Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) and the Belgian health...

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