The gold standard for evaluating medical interventions is a randomised clinical trial with statistical analysis based on the intention-to-treat population. However, even if a randomised clinical trial is well planned, post-randomisation events occur and affect or even challenge the interpretation and validity of the study results.
In November 2019, ICH published an addendum to the ICH E9 guideline to address such problems by the so called “Estimand Framework”. This framework aims to ensure an alignment of trial objectives, study design, data collection, and choice of statistical analysis methods – at the stage of protocol writing.
The interactive workshop is designed for all stakeholders of a clinical study and will include many active training elements (50:50 ratio of theory vs. training)! You will be trained on all topics of the estimand framework. We will present and discuss examples from various study phases and different medical indications. After this hands-on training you will be confident in developing and writing estimands for study protocols.
After the great interest in the estimands workshop last year, we are happy to offer it again! The course will take place on 10 + 11 October 2022. The course will be held in English. You can find more details here.
For questions and registration please contact academy@staburo.de.
