RWE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 16
Alejandra Castanon,
Antonia Tsvetanova,
Sreeram V Ramagopalan
Abstract:In this update, we discuss recent US FDA guidance offering more specific guidelines on appropriate study design and analysis to support causal inference for non-interventional studies and the launch of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) public electronic catalogues. We also highlight an article recommending assessing data quality and suitability prior to protocol finalization and a
Journal of the American Medical Association
-endorsed framework… Show more
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