Medical Writing Patient-reported outcomes Estimands – closing the gap between study design and analysis

Volume 27, Issue 4 - Patient-reported outcomes

Estimands – closing the gap between study design and analysis

Abstract

Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance for events that happen after randomisation. Such postrandomisation events include, for example, treatment discontinuation due to poor tolerability or lack of efficacy, and use of rescue medication. Through a worked example, this article elucidates several different kinds of estimands and shows how the estimands approach has the potential to improve the quality of clinical research. Estimands foster a more complete alignment of study objectives, study design, study conduct, data analysis, and interpretation of results.

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References

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