ICH paper calls for ‘stepwise’ harmonization of RWE

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).

Proposed harmonization approach
The proposed harmonization approach, presented in the Reflection Paper, tackles RWD/RWE terminology and metadata as well as principles around studies and protocols.

The paper listed a tentative timeframe of December 2023 or December 2024 to submit a new ICH topic proposal around RWD/RWE terminology, metadata, and assessment principles. The deliverables for that topic proposal include:

Common operational definitions of RWD/RWE
Common understanding of the breadth of potential RWD sources and the level of granularity needed
Core list and use of metadata
General principles for assessment of RWD/RWE

For RWD/RWE protocols and studies, the paper proposes harmonization around the principles for the structure and content of protocols and reports for medicines developers, as well as recommended best practices for the registration of study protocols and results. The tentative timeframe would be to start work after the first guideline reaches Step 4 of the ICH Procedure.

The Reflection Paper is just the first step in harmonizing regulatory RWE guidance. The paper touches on potential priorities for later ICH guidelines, including best practices for data quality, data standards for RWD, and appropriate application of study designs and data analyses.

Stakeholders can submit comments on the Reflection Paper by 30 September 2023 by emailing [email protected]. Commenters are encouraged to use the ICH public consultation comments template in excel format available here.

ICH Reflection Paper on RWD/RWE

ICH paper calls for ‘stepwise’ harmonization of RWE

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