From Framework to Practice: Practical ADaM Implementation

About this session

Part of Session 6, Track A: Foundational Standards - Validation/Quality (Chair: Harivardhan Jampala, Sumitomo Pharma).

While the ICH E9(R1) estimands framework has reshaped clinical trial planning and analysis, practical implementations at the data‚ standards level remains limited, particularly within ADaM. The final PHUSE WP-092 white paper (2025), building on the draft published in 2023, provides consolidated recommendations to support implementation. Drawing on real‚ world study experience, this presentation describes our practical applications of the estimands framework in ADaM, by leveraging the existing CDISC standards in alignment with the latest PHUSE WP‚ 092 guidance. We demonstrate how key estimand attributes, including treatment, population, variable, intercurrent‚ event handling, and population‚ level summary, are systematically embedded within ADaM datasets to enable traceability. Particular emphasis is placed on implementing different intercurrent‚ event strategies across multiple estimands in ADICE, and on the impact on related ADaM datasets, including subject‚ level population derivations in ADSL. This work provides a concrete, submission‚ ready template for operationalizing PHUSE WP‚092 recommendations.

Speaker

• JY

  Jie Yang

  SGS Pharma – Clinical Research

  Speaker