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A Bayesian perspective on Biogen's aducanumab trial

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机构: [1]German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany [2]Translational Neurodegeneration Section “Albrecht Kossel,” Department of Neurology, University of Rostock, Rostock, Germany [3]Department of Psychological Methods, University of Amsterdam, Amsterdam, the Netherlands [4]Machine Learning Group, Centrum Wiskunde & Informatica, Amsterdam, the Netherlands [5]Department of Neurology, Xuanwu Hospital, National Center for Neurological Disorders, Capital Medical University, Beijing, China [6]Department of Neurology, Duke University School of Medicine, Durham, North Carolina, USA [7]Department of Psychosomatic Medicine and Psychotherapy, University Medicine Rostock, Rostock, Germany
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关键词: aducanumab Alzheimer's disease Bayesian statistics clinical trials

摘要:
This perspective is a companion to a recent editorial on the use of Bayesian analysis in clinical research. We aim to introduce and highlight the relevance and advantages that Bayesian inference offers to clinical trials using the data on the amyloid antibody aducanumab presented at a Food and Drug Administration hearing in November 2020 as an applied example. We apply Bayesian analysis of model plausibility and effect sizes based on simulated data of the two phase 3 trials of aducanumab in prodromal and mild dementia stages of Alzheimer's disease (AD). Bayesian analysis can quantify evidence in favor of, or against, the presence of an effect (i.e., provide evidence of absence), as well as assess the strength of the effect. This is in contrast to the binary conclusions provided by frequentist tests.

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大类 | 1 区 医学
小类 | 1 区 临床神经病学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 临床神经病学
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出版当年[2020]版:
Q1 CLINICAL NEUROLOGY
最新[2023]版:
Q1 CLINICAL NEUROLOGY

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第一作者机构: [1]German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany [2]Translational Neurodegeneration Section “Albrecht Kossel,” Department of Neurology, University of Rostock, Rostock, Germany
通讯作者:
通讯机构: [1]German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany [7]Department of Psychosomatic Medicine and Psychotherapy, University Medicine Rostock, Rostock, Germany [*1]DZNERostock and University Medicine Rostock,Gehlsheimer Str. 20, 18147 Rostock,Germany
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