Event Details
Overview
The webinar will start with providing an overview of surrogacy for licensing and reimbursement. This will articulate 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 will be presented. The importance of right communication of the interpretation of surrogate outcomes to patients will be articulated by a patient representative. Finally, it will be 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. Time is reserved for panel discussion and Q&A.
Who is this event intended for? Clinical trial statisticians involved in evaluation of surrogate outcomes.
What is the benefit of attending? Update on extension of CONSORT/SPIRIT guidance on protocol writing and reporting of randomized controlled trials in which surrogate outcomes are used. Update on expectation setting for surrogacy validation for chronic diseases.
Timings
14:00-16:00 BST | 15:00-17:00 CEST