Staburo @ EMWA Webinar 2025

Inspired by the internal Estimand Strategic Initiatives Working Group—and through many fruitful discussions with biostatisticians, disclosure managers, and medical writers, our Senior Disclosure Manager and Medical Writer, Ulrike Fischer has come to appreciate just how essential estimands are across the medical writing landscape.

The Estimand Strategic Initiatives Working Group, which ran for over a year, explored how the ICH E9(R1) estimand framework influences key clinical development documents, including clinical study protocols, statistical analysis plans, clinical study reports, and disclosure activities. The group examined how endpoints and intercurrent events are handled differently depending on the study phase or indication—whether in oncology, infectious diseases, or diabetes—and learned from colleagues engaged in wider industry initiatives, such as the “Reporting of Estimands” subgroup of the Estimand Implementation Working Group (EIWG) at EFPIA.

In parallel, as an active member of the European Medical Writers Association (EMWA), Ulrike presented a poster at the recent EMWA Spring Conference in Valencia: “An Attempt to Translate Estimands into Plain Language.”
The poster aimed to bridge the gap between complex estimand concepts and clear, accessible communication. Through conversations at the conference and on LinkedIn, Ulrike found that while many medical writers are familiar with the estimand framework in theory, relatively few have applied it in practice. It became evident that, so far, estimands have only marginally entered the day-to-day world of medical writing.

Recognising that medical writers serve as connectors across disciplines, Ulrike emphasizes that developing a strong understanding of estimands enhances how clinical documents are authored, reviewed, and structured—bringing greater clarity and scientific rigor to the work.

Another highlight of the year was hosting the webinar “Estimands in Protocols” for the EMWA Regulatory Writing Special Interest Group in April.
Over 100 medical writers from around the world participated, contributing to lively, thought-provoking discussions and providing encouraging feedback. She is grateful to her colleagues, the EMWA community, and the inspiring co-leaders who helped make the webinar such a success.

Looking Ahead: EMWA Spring Conference 2025
Ulrike is excited to participate in the upcoming EMWA Spring Conference this May in Riga. She is looking forward to connecting with colleagues and continuing the conversation about estimands and the evolving role of medical writing.