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Time-to-event estimands are central to many oncology clinical trials. Theestimand framework (addendum to the ICH E9 guideline) calls for preciselydefining the treatment effect of interest to align with the clinical questionof interest and requires predefining the handling of intercurrent events thatoccur after treatment initiation and either preclude the observation of anevent of interest or impact the interpretation of the treatment effect. Wediscuss a practical problem in clinical trial design and execution, i.e. insome clinical contexts it is not feasible to systematically follow patients toan event of interest. Loss to follow-up in the presence of intercurrent eventscan affect the meaning and interpretation of the study results. We providerecommendations for trial design, stressing the need for close alignment of theclinical question of interest and study design, impact on data collection andother practical implications. When patients cannot be systematically followed,compromise may be necessary to select the best available estimand that can befeasibly estimated under the circumstances. We discuss the use of sensitivityand supplementary analyses to examine assumptions of interest.

Time-to-event estimands and loss to follow-up in oncology in light of the estimands framework