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Titlebook: Data Monitoring in Clinical Trials; A Case Studies Appro David L. DeMets,Curt D. Furberg,Lawrence M. Friedm Book 2006 Springer-Verlag New Y

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https://doi.org/10.1007/978-3-030-50405-2ducing overall mortality, thus vindicating the recommendations of the DSMB to keep the trial open until the planned follow-up had been completed. This paper is a review of the DSMB process for this study, and how the Board dealt with the challenges of interpretation of apparently contradictory evide
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Claudia Padovani,Andrew Calabrese multiple endpoints of interest, other concerns that were addressed included a reassessment of study sample size and power subsequent to a lengthy suspension of accrual during the trial and handling the occurrence of an unexpected ocular toxicity in association with tamoxifen. Although there were nu
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Media Justice and Communication Rightsths in the placebo group and 269 in the spironolactone group for an estimated hazard ratio of 0.78 (p = 0.00018). The board recommended early termination of the trial because the observed Z-value of 3.75 exceeded the pre-specified critical value of 2.79 and the data on mortality showed consistency a
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The Essentials of Nursing Management Seriesall-cause mortality in the overall program. The overarching principle of the DSMC was proof beyond a reasonable doubt that would be likely to influence clinical practice..There were significant treatment differences in all-cause mortality at several interim analyses, and the statistical stopping gui
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Introduction to Case Studies Showing Benefit from the Intervention
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Introduction to Case Studies Showing Harmful Effects of the Intervention
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Book 2006s presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. The editors provide an overview of the process and a summary of a multitude of the lessons learned from the cases presented...This book should be useful to anyone serving on a data and sa
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Data Monitoring for the Aspirin Component of the Physicians’ Health Study: Issues in Early Terminatil event. Several additional factors were involved, including little or no trend in either CVD mortality or stroke, although the numbers of events were too low to distinguish between small benefit, no effect, and small harm. These circumstances suggested clear evidence for aspirin in preventing a fir
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