Utilizing registry data in benefit assessments of new drugs: the IQWiG perspective

Written by Ilana Landau, Editor
Decision science Health policy Health technology assessment Medical devices, pharmaceuticals and vaccines Methodology News Real-world evidence Stakeholder engagement
real-world evidence from real-world data

The Institute for Quality and Efficiency in Health Care (IQWiG; Cologne, Germany) has developed and published a set of criteria pertaining to how high-quality registry data could be analyzed and utilized to determine the extended benefit of novel drugs, particularly those for rare diseases. Oftentimes, at the time of marketing of orphan drugs and drugs processed for accelerated approval, there is not enough evidence to assess the added benefits associated with these therapies. To help address this shortfall, the Institute for Quality and Efficiency in Health Care (IQWiG; Cologne, Germany) has developed a set of scientific concepts concerning how data generated...

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