ICH Reflection paper on proposed international harmonization of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of drugs

Real-world data and real-world evidence play an increasingly important role in clinical research and healthcare decisionmaking. To use data and generate robust evidence effectively, they must be clearly defined and structured, semantically compatible and harmonized among stakeholders. On June 30, 2023, the International Council on Harmonization (ICH) presented for discussion a reflection paper on “International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines”, which outlines their approach to achieve international integration in this area. This article provides an overview of the key aspects of the strategic plan proposed by the ICH.