We highly recommend the article “Principles and recommendations for incorporating estimands into clinical study protocol templates”, providing advice on how to set the ICH E9 (R1) addendum 2019 into practice. The article was co-written by Metronomia’s Director Biostatistics, Volker Schoder, and recently published by the open access journal “Trials”.

Since the ICH E9 (R1) addendum 2019 requires the inclusion of estimands in clinical trial protocols without going too much into details on how to do so, the clinical research world is looking for the best way to put the addendum into practice. Under the umbrella of EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) an interdisciplinary working group of pharma professionals, authority- and CRO members, teamed up to work on practical guidelines to advise biopharmaceutical sponsors planning to develop or update their clinical study protocol templates to efficiently incorporate the paradigm shift from endpoints alone to estimands.

The advice and recommendations are summed up in the following article:

https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-022-06515-2.pdf