Chrissie Fletcher, David Wright, Kaspar Rufibach.
We will consider impacts on ongoing case studies in chronic obstructive pulmonary disease (COPD) and oncology. The COVID 19 pandemic causes disruption of healthcare systems leading to inaccessibility of sites, treatment interruptions and discontinuations, missed or delayed visits, use of unexpected concomitant medications and deaths. The scale of the impact will vary depending on our target population, therapeutic area and the timing of study recruitment relative to the course of the COVID-19 pandemic.
We will show how the estimand framework helps us to:
• revise the treatment effects of interest considering all five estimand attributes including accommodation of unexpected intercurrent events;
• propose sensitivity analyses to explore robustness of departures from assumptions (including missing data assumptions);
• propose supplementary analyses to more fully investigate and understand the trial data.
Our case studies will illustrate how pre-specified estimands are impacted by the COVID-19 pandemic, and how methods for estimation including sensitivity analyses may need to be reconsidered to address missing data issues.