Assessing treatment benefit in the presence of placebo response using the sequential parallel comparison design.
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DOI: 10.1002/sim.9349
Abstract: In clinical trials, placebo response is considered a beneficial effect arising from multiple factors, including the patient's expectations for the treatment. Its presence makes the classical parallel study design suboptimal and can bias the inference.… read more here.
Keywords: design; placebo response; treatment; sequential parallel ... See more keywords
Placebo Response as a Latent Characteristic: Application to Analysis of Sequential Parallel Comparison Design Studies
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DOI: 10.1080/01621459.2017.1375930
Abstract: ABSTRACT In clinical trials, placebo response can affect the inference about efficacy of the studied treatment. It is important to have a robust way to classify trial subjects with respect to their response to placebo.… read more here.
Keywords: response; latent characteristic; placebo response; response latent ... See more keywords
Sample size calculation for the sequential parallel comparison design with binary endpoint using exact methods
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DOI: 10.1080/02664763.2024.2385997
Abstract: High placebo responses in clinical trial could reduce the treatment effect leading to the failure of a promising drug. Several strategies have been developed to minimize high placebo responses, including the sequential parallel comparison design… read more here.
Keywords: sample size; sequential parallel; comparison design; parallel comparison ... See more keywords