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Semin Liver Dis 2021; 41(02): 163-171
DOI: 10.1055/s-0041-1723753
Review Article

Blinding in Clinical Trials for Chronic Liver Diseases

Vivian Ortiz
1   Division of Gastroenterology and Hepatology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
,
Susan S. Ellenberg
2   Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
,
Ethan M. Weinberg
1   Division of Gastroenterology and Hepatology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
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Abstract

Within the field of randomized clinical trials (RCTs), the randomized double-blind placebo-controlled clinical trial is considered the most efficient means of simultaneously assessing the efficacy and safety of a medical therapy in a single trial. While many RCTs are conducted without blinding (open label), it is rare to encounter a blinded trial that does not randomize its subjects. Clinical trials for chronic liver diseases have adopted many of the practices set forth by RCTs in other chronic diseases, but blinding has often been difficult to properly implement. This review examines the rationale for blinding, common challenges to successful blinding, different mechanisms of unintentional unblinding in clinical trials for viral hepatitis and nonalcoholic steatohepatitis, and recommendations for blinding and design in future trials of treatments for liver disease.

Keywords

blinding - clinical trials - randomization - liver disease

Financial Support

E.M.W. received salary support from the University of Pennsylvania Institute for Translational Medicine and Therapeutics Clinical Trials Fellowship.


Disclosures

E.M.W. is a site coinvestigator for clinical trials involving the following medications discussed in the review: elbasvir-grazoprevir, sofosbuvir-velpatasvir, glecaprevir-pibrentasvir, obeticholic acid, selonsertib, emricasan, pegbelfermin.


V.O.—no conflicts.


S.S.E.—no conflicts.




Publikationsverlauf

Artikel online veröffentlicht:
06. Mai 2021

© 2021. Thieme. All rights reserved.

Thieme Medical Publishers, Inc.
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