Implementing the Estimand Framework in Medical Publications: Challenges and Best Practices

Thomas M. Menino Convention & Exhibition Center 

Room: CC-210A 

With the adoption of ICH E9(R1) and the recently introduced ICH M11 protocol template, estimand-based reporting is becoming central to clinical trial transparency. However, practical guidance on implementing this framework in medical publications remains limited. While many journals have guidance for trial reporting, estimands are often not explicitly covered. This session will bring together statisticians from academia (some serving on the editorial board for top medical journals) and industry to explore the implications of the estimand framework for trial reporting and share best practices.
Two expert presentations will set the stage for a panel discussion. The first, by Vladimir Dragalin (J&J), will describe the estimand-centric structure of the ICH M11 template and the rationale for moving away from endpoint-driven objectives. It will emphasize the importance of pre-specifying trial objectives and their role in regulatory interactions. The second, by Gabriele Bleckert (Staburo GmbH), will summarize recommendations from Lanius et al. (2025) on applying the estimand framework in publications, including strategies for reporting intercurrent events, linking results to estimands, and aligning reporting with study objectives. A case study will illustrate these principles.
The session will conclude with a panel discussion featuring the speakers, two statistical editors from major medical journals - Constatine Gatsonis (NEJM) and Patrick Heagerty (JAMA) - and an experienced industry statistician – Patrick Darken (AstraZeneca). The panel will address current practices and potential future improvements for manuscript authors and journals.
Reference:
Lanius V, Glocker B, Lösch C, Bratton DJ, Callegari F, Wright M, Rajamäki S. Realizing the benefits of the estimand framework when reporting and communicating clinical trial results-some recommendations. Trials. 2025;26:241. doi:10.1186/s13063-025-08915-6.

Yes

Biopharmaceutical Section

ENAR

Section on Statistical Consulting