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Estimands: A 360-degree Approach for Medical Writers

Drug Development
Workshop profile:
The workshop is for MWs working in the CRO or pharma environment, who have written at least one or reviewed several clinical study protocols (CSPs). Managers of MW groups will also benefit from understanding estimand-driven processes that impact business and wider operational considerations.
The workshop is designed to facilitate interpretation of the International Council for Harmonisation (ICH) guideline E9(R1) 2019, which drives estimand development into trial design, and to clarify the MW’s role and responsibilities in relation to that of medical experts and statisticians in ensuring that estimands are considered as part of a proactive cross-functional approach to writing the CSP. At the end of the workshop, attendees should understand the concept of estimands and their impact on CSPs and other study-level documents, and have acquired the knowledge and skills to author or review CSPs that include estimands.
Inclusion of estimands into confirmatory clinical trials is mandated through ICH guidance E9(R1) 2019, which is targeted at statisticians but also needs to be understood by MWs who often lead on CSP design and development. A general process will be described to enable MWs to develop and describe estimands at a level appropriate for the CSP. Open access resources will be demonstrated and some illustrative examples will be presented to clarify statistical concepts associated with estimands. To enhance learning, attendees will work on examples provided during the workshop. Detailed statistical analysis methods will not be covered in the workshop.