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Titlebook: Data Monitoring Committees (DMCs); Past, Present, and F Nand Kishore Rawat,David Kerr Book 2023 The Editor(s) (if applicable) and The Autho

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發(fā)表于 2025-3-21 18:30:22 | 只看該作者 |倒序瀏覽 |閱讀模式
書目名稱Data Monitoring Committees (DMCs)
副標(biāo)題Past, Present, and F
編輯Nand Kishore Rawat,David Kerr
視頻videohttp://file.papertrans.cn/263/262982/262982.mp4
概述Provides thorough instructions on the steps needed to form and implement a data monitoring committee.Includes practical and hands-on information on DMC implementation.Discusses smaller more flexible s
圖書封面Titlebook: Data Monitoring Committees (DMCs); Past, Present, and F Nand Kishore Rawat,David Kerr Book 2023 The Editor(s) (if applicable) and The Autho
描述.Thisbook provides an overview of Data Monitoring Committees(DMC) - what was donein the past, what is currently being done, and thoughts on improvementsfor the future. Previous works focused primarily on largecardiovascular studies (where DMCs originated more than 30 years ago)but updated references are needed that discuss smaller, more flexiblestudies in areas such as oncology. The authors have attended ~800 DMCmeetings from ~200 distinct studies across all areas of clinical studies(oncology, rheumatology, rare diseases, cardiology, immunology, etc.)This wide range of expertise will be used, as well as the expertise thatcomes from working with virtually every large?biotechnology and pharmaceutical company?and CROfor DMC work. The reader of the book will know when DMCs are needed orhelpful, how to form the DMC, how to work with external CROs and withsponsor teams and the DMC to create needed DMC outputs, how the DMCmeetings are conducted, and - especially for DMC members - what areconsiderations within the Closed Session to review safety/efficacyoutputs to assess risk/benefit to make appropriate recommendations thatprotect the patient safety and trial integrity..Thisis a practical
出版日期Book 2023
關(guān)鍵詞Clinical Trials drug approval; Clinical trials vaccine approval; FDA drug approval; unbiased review of
版次1
doihttps://doi.org/10.1007/978-3-031-28760-2
isbn_softcover978-3-031-28762-6
isbn_ebook978-3-031-28760-2
copyrightThe Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl
The information of publication is updating

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發(fā)表于 2025-3-21 23:57:36 | 只看該作者
Physiogenic Hearing Impairment in Adultsta, and then making recommendations. These recommendations are made to help ensure study integrity and to protect the patients – ultimately up to recommending stopping the study to protect patient safety against undue risk, or due to established statistical futility or statistical benefit.
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https://doi.org/10.1007/978-3-031-79986-0ta is captured and categorized. Detailed list of adverse outputs of most use to the DMC is given, with numerous examples of figures. Proposals for useful summarizations (including figures) from deaths, laboratory data, vital signs data, and other data sources are also provided.
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發(fā)表于 2025-3-22 13:36:46 | 只看該作者
https://doi.org/10.1007/978-3-031-79986-0ssessment of risk-benefit to provide more suitable DMC recommendations. The hazards of repeated assessment of efficacy data are noted, as are the hazards of overinterpreting early trends or lack of early trends. The principles of interpreting p-values are provided.
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發(fā)表于 2025-3-22 18:04:05 | 只看該作者
https://doi.org/10.1007/978-3-031-79281-6t, especially for studies with more than two treatments or more than one primary treatment phase. Suggestions are provided on the look-and-feel of the DMC package sent to the DMC so that it is both comprehensive, but also comprehensible.
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