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29 May 2024

Oriana Ciani (SDA Bocconi School of Management), Rod Taylor (University of Glasgow; University of South Denmark), Anthony Manyara (Bristol university; University of Glasgow), Ray Harris (Retired), Mario Ouwens (AstraZeneca).

This webinar starts with providing an overview of surrogacy for licensing and reimbursement. This articulates the need of extensions of the SPIRIT and CONSORT statement related to surrogacy. Both the process to define the extensions as well as the extensions themselves are then presented. The importance of right communication of the interpretation of surrogate outcomes to patients is articulated by a patient representative. Finally, it is shown by results from a simulation study that maturity influences the probability of success of surrogacy validation, among other factors like variation in estimated treatment effects.

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