All Times EDT
Keywords: Estimand, missing data, COVID-19 impact, intercurrent event, sensitivity analysis, ICH E9(R1)
The COVID-19 pandemic interferes with the conduct of many ongoing trials, including the collection, analysis and the interpretation of clinical trial data. The structured framework of the ICH E9 (R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials” is appropriate for assessing the impact of COVID-19 on ongoing trials and assuring their integrity, validity of the statistical analyses, and their interpretability. We will discuss potential impact of this pandemic on each of the five attributes of an estimand, followed by related points to consider for statistical analysis and handling of missing information. The COVID-19 impact can be manifested by either (i) trial conduct being affected by the lockdown triggered by the pandemic, some of the trial conduct changes having also a direct impact on participants (e.g. missed doses or treatment discontinuation), or (ii) participants being infected with COVID-19 (confirmed by a test or not). These two types of impact will translate into different types of intercurrent events leading to different estimand components.