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

The COVID-19 pandemic continues to affect the conduct of clinical trials globally. Complications may arise from pandemic-related operational challenges such as site closures, travel limitations and interruptions to the supply chain for the investigational product, or from health-related challenges such as COVID-19 infections. Some of these complications lead to unforeseen intercurrent events in the sense that they affect either the interpretation or the existence of the measurements associated with the clinical question of interest. In this article, we demonstrate how the ICH E9(R1) Addendum on estimands and sensitivity analyses provides a rigorous basis to discuss potential pandemic-related trial disruptions and to embed these disruptions in the context of study objectives and design elements. We introduce several hypothetical estimand strategies and review various causal inference and missing data methods, as well as a statistical method that combines unbiased and possibly biased estimators for estimation. To illustrate, we describe the features of a stylized trial, and how it may have been impacted by the pandemic. This stylized trial will then be revisited by discussing the changes to the estimand and the estimator to account for pandemic disruptions. Finally, we outline considerations for designing future trials in the context of unforeseen disruptions.Copyright © 2022 American Statistical Association.

Stock markets’ reaction to COVID-19, US lockdown and waves: the case of fast food and food delivery industry

This paper examines the short-term market reaction of large fast food and food delivery companies to the arrival of the COVID-19 pandemic, US lockdown, and contagion waves. Using an event study, we show that stocks react significantly negatively to the declaration of COVID-19 as a global pandemic but react positively to US lockdown and contagion waves. The change in consumers’ buying behaviour with over-consumption of online experiences tends to explain the positive stock market reaction. These reactions are reinforced or mitigated by firm-specific characteristics such as liquidity, profitability, leverage, institutional ownership, and degree of internationalization. © 2021 Informa UK Limited, trading as Taylor & Francis Group.