Purpose
The North America Estimands Implementation Working Group (NA EIWG) is a scientific working group within the ASA Biopharmaceutical Section focused on building a North America community to share experiences with estimand implementation, surface common challenges, and collaborate on practical solutions.
Key topics and activities
- Identify implementation challenges and misconceptions in applying the estimand framework (e.g., via surveys and structured feedback).
- Share case studies spanning a range of clinical questions and stakeholder needs, anchored in clinical context.
- Engage medical journals and other stakeholders to promote clear, consistent reporting practices for estimands.
- Discuss protocol implementation practices, including adoption of the ICH M11 protocol template (2025), to support an estimand-thinking process and interdisciplinary collaboration—starting from clear trial objectives and clinical questions in natural, non-technical language.
- Explore how the estimand framework can be reflected in product labeling.
- Address methodological challenges related to estimation.
How we work
We plan to advance these topics through webinars (leveraging ASA Biopharmaceutical Section and ASA Chapters platforms), conference sessions, and collaborative publications.
Collaboration
We will collaborate closely with the European-based EFSPI/EFPIA EIWG - Estimands Implementation Working Group (EIWG) through regular communication and joint events, and we also plan to coordinate with other global EIWG efforts.
Get involved / Contact
If you’d like to get involved or would like more information, please contact the co-chairs:
- Elena Polverejan (Johnson & Johnson) – epolvere@its.jnj.com
- Patrick Darken (AstraZeneca) – patrick.darken@astrazeneca.com