Masking of Trial Investigators

George Howard () and Jenifer H. Voeks ()
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George Howard: University of Alabama at Birmingham, Department of Biostatistics
Jenifer H. Voeks: Medical University of South Carolina, Department of Neurology

Chapter 43 in Principles and Practice of Clinical Trials, 2022, pp 805-814 from Springer

Abstract: Abstract The substantial investment of both time and money to mount a clinical trial would not be made without an underlying belief that the new treatment is likely beneficial. While a lack of definitive evidence can underpin the equipoise of investigators that is necessary to mount a new trial, the success in previous early phase trials (or even animal models) provides a natural foundation for an expected benefit in subsequent phase trials. Both investigators and patients can share this belief, and these expectations of treatment efficacy for new therapies introduce the potential for bias in clinical trials. The benefits, completeness, and reporting of masking in clinical trials are described, as they are approaches for implementing and maintaining the mask.

Keywords: Masking; Blinding; Assessment of outcomes (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_215

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