Implementing optimal allocation in clinical trials with multiple endpoints
نویسندگان
چکیده
منابع مشابه
Analysis of Multiple Endpoints in Clinical Trials
Most human diseases are characterized by multidimensional etiology and the efficacy of an experimental treatment frequently needs to be assessed on multiple outcome measures — commonly referred to as endpoints. There is a variety of ways in which the contribution of each endpoint can be accounted for in the primary analysis, for example, the trial’s sponsor can treat endpoints as independent en...
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Rationale for adaptive designs with multiple endpoints In clinical trials, the efficacy of a new treatment is usually assessed by a single primary endpoint [1,2]. Other important aspects concerning the new treatment, such as adverse events or quality of life, are taken into account by the definition of secondary endpoints. Usually, only the primary endpoint is analyzed confirmatorily with a sta...
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This paper summarizes, defines, and discusses multiple endpoints comparison procedures, concepts, and methodologies for applications to clinical trials. We address the more widely used methods of alpha-level, p-value, and critical value adjustments. We examine global assessment measures such as O'Brien's test and Simes' procedure and contrast them with the alpha-adjustment procedures of Bonferr...
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Composite endpoints are often used in clinical trials, especially in the cardiovascular area. Decreases in sample size requirements, ability to assess the net effect of an intervention and to avoid bias in presence of competing risks are the most cited advantages for their use. However, there is a risk of misinterpretation when heterogeneity among components with respect to either importance, n...
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Economic endpoints are increasingly common in randomized clinical trials. As a relatively new addition to the field, methods of measuring and analyzing cost data are still evolving. These developments will be stimulated by the demands of the public for efficient and effective medical care, which will be based on the findings of clinical trials.
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ژورنال
عنوان ژورنال: Journal of Statistical Planning and Inference
سال: 2017
ISSN: 0378-3758
DOI: 10.1016/j.jspi.2016.09.002