Regulators are formally adopting real-world evidence, when will health technology assessment?

By Danélia Botes

March 13, 2023

Over the last year, we’ve made great progress towards this goal. In June 2022, NICE published our real-world evidence framework.

The EMA and the European Medicines Regulatory Network recently established the Data Analysis and Real World Interrogation Network (DARWIN EU®). Using the OMOP CDM, DARWIN EU® delivers real-world evidence from across Europe on diseases, populations and the use and performance of medicines. This enables EMA and other organisations in the European medicines regulatory network to use this data whenever needed throughout the lifecycle of a medicinal product.

A workshop hosted by Dr Ravinder Claire outlines 2 case studies:
1) Difficulties in health technology assessment agencies when assessing treatments for cancer with the uncertainty surrounding long-term projections for overall survival.
2) COVID-19 projects in collaboration with the University of Oxford, where data from the EHDEN network is used to assess the effectiveness of baricitinib, tocilizumab and remdesivir in a hospital setting.

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