What Do Biostatisticians Think Of The ICH E9(R1) Addendum?

The ICH E9(R1) Addendum on Estimands and Sensitivity Analysis has recently been introduced to improve the process of clinical trials. The Addendum aims to facilitate clear communication between sponsors and regulatory authorities when addressing the treatment effects of interest in a clinical trial. Although some in the clinical trials community were initially skeptical of the new framework, it has gained recognition as an opportunity for enhancing trial objectives and aligning conduct with research questions.

The COVID-19 pandemic has accelerated the adoption of the estimand framework, as it offers a method for differentiating intercurrent events related and unrelated to the pandemic. Biostatisticians play a crucial role in guiding discussions among study teams to ensure awareness and effective communication. This article highlights the views of Kristina Bondareva, Head of the Biostatistics Department at palleos healthcare, on the significance of the Addendum and the importance of adopting the estimand framework in clinical trials.