The International Council for Harmonisation (ICH) issued a Reflection Paper outlining a “stepwise” approach to harmonization of real-world data and evidence (RWD/RWE) that includes common operational definitions, general principles for assessment, and best practices for registration of study protocols and results.
The ICH Assembly endorsed the Reflection Paper in June 2023, and it is under public consultation until 30 September 2023. Any comments received by that date will be considered for inclusion in the final Reflection Paper, anticipated to be adopted in June 2024.
The goal behind issuing the paper is to enable the integration of RWE into regulatory submissions and timely decision-making. “The ultimate benefit of this work is expected to be higher quality RWE that can substantially contribute to the body of evidence supporting the benefit and risk decision-making on medicines,” the Reflection Paper states.
The paper comes as the US, Canada, and the European Union all have begun to issue frameworks on the use RWD/RWE, which contain similar definitions as well as inconsistencies. The variability in definitions, ways of describing sources, and methodologies have led to different estimates on how RWD/RWE is being applied in regulatory applications, according to the report (RELATED: FDA finalizes guidance on submitting RWD/RWE in application cover letters, Regulatory Focus 13 September 2022)…
