Only about eight months to go until publication of a Step 3 draft of the Revision 1 (R1) addendum to the ICH E9 Guideline as announced by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
While the initial guideline E9 on statistical principles for clinical trials was published back in 1998, almost 20 years later time is more than ripe for an update as the regulatory framework as well as methodological progress and community focus have changed over the last two decades.
While many topics addressed by ICH E9 are still valid and important to be properly considered for today’s clinical research activities, the main trigger for E9(R1) was the increasing need for well-defined sensitivity analyses including consideration of missing values in clinical data in many ways like by means of multiple imputation. Also, the concept of estimands is to be introduced to the set of recommendations.
Estimondo GmbH is at the forefront of these activities as estimands are our primary business. We will keep you updated about the publication plan by the ICH and are currently preparing materials for a webinar to introduce the concept of estimands to a broad audience free of charge. Please check out our news regularly to notice when the webinar is going to be scheduled to register for one of the spots offered.