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The COVID-19 pandemic continues to affect the conduct of clinical trialsglobally. Complications may arise from pandemic-related operational challengessuch as site closures, travel limitations and interruptions to the supply chainfor the investigational product, or from health-related challenges such asCOVID-19 infections. Some of these complications lead to unforeseenintercurrent events in the sense that they affect either the interpretation orthe existence of the measurements associated with the clinical question ofinterest. In this article, we demonstrate how the ICH E9(R1) Addendum onestimands and sensitivity analyses provides a rigorous basis to discusspotential pandemic-related trial disruptions and to embed these disruptions inthe context of study objectives and design elements. We introduce severalhypothetical estimand strategies and review various causal inference andmissing data methods, as well as a statistical method that combines unbiasedand possibly biased estimators for estimation. To illustrate, we describe thefeatures of a stylized trial, and how it may have been impacted by thepandemic. This stylized trial will then be re-visited by discussing the changesto the estimand and the estimator to account for pandemic disruptions. Finally,we outline considerations for designing future trials in the context ofunforeseen disruptions.

Estimands and their Estimators for Clinical Trials Impacted by the  COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on  Unplanned Clinical Trial Disruptions