Estimands for RWD/RWE

Estimands for RWD/RWE

Project Scope 

The 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 on HTA and RWE, both with estimands expertise, along with representation from teams under the RWE Working 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.

Project Leads

Email

Project Leads

Email

Ksenia Titorenko, ICON

Ksenia.Titorenko@iconplc.com

Matt Baldwin, Amgen

mbaldw01@amgen.com

Paramita Chakraborty, IQVIA

paramita.chakraborty@iqvia.com

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global 

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