Rudell K, Doward L, Bennett B, Rodriguez AM, Jane Rylands AJ. Expanding COA in 2020 – guidance in RWE and improving communication between different stakeholders. Presented at the Virtual ISPOR Europe 2020; November 11, 2020.


The Clinical Outcomes Assessment (COA) Special Interest Group’s focused this past year on harmonizing COA nomenclature and value as well as align guidance for COA generation in real world (RW) studies which are often presented to regulatory and HTA agencies. Bryan Bennett and Lynda Doward will discuss the results of a membership survey which identifies how different stakeholders value PRO data in their professional decision-making based on their current and projected use of COA data . Additionally as part of the key project, they will present the preliminary findings from a review of HTA terminology used for COA from different countries that will help to inform our understanding with an aim to a degree of harmonize the way Health Economic and Outcome Research scientists and COA specialists describe COA value. Angela Rylands and Ana Maria Rodriguez would like to involve COA experts attending ISPOR in aligning next steps in their proposal of new guidelines and best practices for COA in real world evidence (RWE) studies. They will share a draft manuscript framework, which aims to summarize the output from the virtual expert meeting and international survey with industry, regulatory and HTA/payer agencies hosted at the end of 2019 which collected views on the use of COA in RWE.

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