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Abstract:
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The ICH E9 (R1) Addendum on estimands and sensitivity analysis in clinical trials, promotes harmonised standards on the choice of estimand in clinical trials and describes an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. It is intended to better align the choice of statistical methods with questions of regulatory importance and to improve the reliability of decisions about and representations of the effects of medical products. The draft addendum was released in August 2017 and is currently in a consultation period. Nevertheless, the addendum has already started to have an impact as new clinical trials have aligned with the principles outlined in the draft. To help build a knowledge bank that will aid the practical implementation of the addendum, sharing of experiences among statisticians is essential. With respect to this aim, here we will discuss a case study based on clinical trial with a radiographic endpoint. Different estimands, which were under consideration when designing the study, will be presented together with sensitivity analyses to answer the primary objective of the trial.
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