History of the working group

The draft addendum of the ICH E9 guideline on Statistical Principles for Clinical Trials was released in August 2017 and introduced an estimand framework. In February 2018, Evgeny Degtyarev from Novartis and Kaspar Rufibach from Roche started an informal working group to discuss how to implement the draft addendum in oncological clinical trials.

In November 2018, the working group was subsequently established more formally by EFSPI as European special interest group “Estimands in oncology”, sponsored by PSI and EFSPI and in June 2019 the ASA biopharmaceutical section has granted the official status as ASA scientific working group.

In December 2019, the final version of the ICH E9 estimand addendum was published.