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12 June 2023

Sue McKendrick, Helle Lynggaard, Sunita Rehal, Antonia Morga, Pepa Polavieja.

At the end of July 2020 the European Medicines Agency (EMA) adopted ICH E9(R1). Whilst some other regulatory agencies have also adopted ICH E9(R1), implementation and adoption of ICH E9(R1) is still progressing and slowly impacting a wide range of clinical research. Much of the discussion to date on ICH E9(R1) has focussed on adopting estimands for confirmatory superiority clinical trials from the perspective of regulatory submissions. This session reflects on the potential to use the estimand framework in others types of clinical trials and for decision making by other stakeholders such as Payers. In particular, this session focuses on use of estimands in PK studies and studies in early phases of development, the use of estimands in non-inferiority studies and the potential to use estimands in Health Technology Assessment. It reviews some of the key challenges statisticians are facing across these different dimensions.  

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