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

• Published in: Statistics in biopharmaceutical research Vol. 15; no. 1; pp. 94 - 111
• Main Authors: Van Lancker, Kelly, Tarima, Sergey, Bartlett, Jonathan, Bauer, Madeline, Bharani-Dharan, Bharani, Bretz, Frank, Flournoy, Nancy, Michiels, Hege, Olarte Parra, Camila, Rosenberger, James L., Cro, Suzie
• Format: Journal Article
• Language: English
• Published: Taylor & Francis 02.01.2023
• Subjects: Causal inference; Hypothetical estimands; Intercurrent events; Missing data; Treatment policy

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 s...