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The team that is formed would have representation from the PHUSE Implementation of Estimands (ICH E9 (R1)) using Data Standards project team with Estimands , and the EIWG, both with estimands expertise, along with representation from various teams under the RWE working groupWorking Group. It seems appropriate that this would be a new team under the RWE working groupWorking Group, with knowledge contribution from the Estimands estimands implementation team, since the focus of this project is at this time on best practices of RWD Estimandsestimands, not on their implementation using data standards at this time.

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 (RCTs). From my knowledge, only one FDA 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 PHUSE Implementation of Estimands (ICH E9 (R1)) using Data Standards project team that , which has a white paper currently in public reviewnearing publication, along with other PHUSE RWE working group Working Group project team expertise as welland the Estimands Implementation Working Group (EIWG) subteam on HTA and RWE. The EIWG subteam on HTA and RWE started about 18 months ago, and has a cross-functional membership, including regulators, statisticians, epidemiologists and health economists.