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-Reference-Cited by-同舟云学术

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:2022-09-14 Issue:1 Volume:15 Page:94-111
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Van Lancker Kelly¹²^ORCID,Tarima Sergey³^ORCID,Bartlett Jonathan⁴^ORCID,Bauer Madeline⁵,Bharani-Dharan Bharani⁶,Bretz Frank⁷⁸^ORCID,Flournoy Nancy⁹^ORCID,Michiels Hege²^ORCID,Olarte Parra Camila⁴^ORCID,Rosenberger James L.¹⁰^ORCID,Cro Suzie¹¹^ORCID

Affiliation:

1. Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD

2. Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium

3. Division of Biostatistics, Medical College of Wisconsin, Milwaukee, WI

4. Department of Mathematical Sciences, University of Bath, Bath, UK

5. Division of Infectious Diseases, Keck School of Medicine, University of Southern California (ret), Los Angeles, CA

6. Novartis Pharmaceuticals, East Hanover, NJ

7. Novartis Pharma AG, Basel, Switzerland

8. Section for Medical Statistics, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria

9. Department of Statistics, University of Missouri (emerita), Columbia, MO

10. National Institute of Statistical Sciences, and Department of Statistics, Penn State University, University Park, PA

11. Imperial Clinical Trials Unit, Imperial College London, London, UK

Funder

Fulbright Belgium

Belgian American Educational Foundation

VLAIO

Department of Health and Human Services of the National Institutes of Health

UK Medical Research Council

NIHR advanced research fellowship (NIHR

National Institutes of Health

NIHR or the Department of Health and Social Care

Agentschap Innoveren en Ondernemen

Medical Research Council (MRC) International Centre for Genomic Medicine in Neuromuscular Disease

National Institute of Health Research

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2022.2094459

Reference45 articles.

1. Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials

2. Asymptotic Z and chi-squared tests with auxiliary information

3. Perspectives on Virtual (Remote) Clinical Trials as the “New Normal” to Accelerate Drug Development

4. Doubly Robust Estimation in Missing Data and Causal Inference Models

5. Improving precision and power in randomized trials for COVID‐19 treatments using covariate adjustment, for binary, ordinal, and time‐to‐event outcomes

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