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The team that is formed would have focus of this project is on best practices of RWD estimands, not on their implementation using data standards. The team formed has representation from the PHUSE Implementation of Estimands (ICH E9 (R1)) using Data Standards project team, which has a White Paper nearing publication, and the Estimands Implementation Working Group (EIWG) sub team with Estimands on HTA and RWE, both with estimands expertise, along with representation from various teams under the RWE working group. It seems appropriate that this would be a new team under the RWE working group, with knowledge contribution from the Estimands implementation team, since the focus of this project is on best practices of RWD Estimands, not on their implementation using data standards at this timeWorking Group. The EIWG sub team on HTA and RWE started in late 2022, and has a cross-functional membership, including regulators, statisticians, epidemiologists and health economists.

There is currently very little guidance or discussion on how to construct Estimands estimands for RWD/RWE, including how it is similar or different from randomised clinical trials (RCTsRCTs). From my knowledge, only As of Q1 2024, one FDA guidance guidance related to RWD/RWE mentions Estimandsestimands: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Guidance for Industry – Feb February 2023 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products). This is a good start, but expanding these principles with more guidance and examples provides an opportunity.

It would be helpful to many stakeholders across the Pharma pharma and biotech industries to discuss and make available best practices for RWD Estimandsestimands, including how they are similar or different from Estimands estimands in RCTs. It is expected to borrow expertise from the Implementation of Estimands (ICH E9 (R1)) using Data Standards project team that has a white paper currently in public review, along with other RWE working group project team expertise as well.