| 书目名称 | Data Monitoring Committees (DMCs) | | 副标题 | Past, Present, and F | | 编辑 | Nand Kishore Rawat,David Kerr | | 视频video | | | 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 | | 图书封面 |  | | 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 | | 关键词 | Clinical Trials drug approval; Clinical trials vaccine approval; FDA drug approval; unbiased review of | | 版次 | 1 | | doi | https://doi.org/10.1007/978-3-031-28760-2 | | isbn_softcover | 978-3-031-28762-6 | | isbn_ebook | 978-3-031-28760-2 | | copyright | The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl |
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发表于 2025-3-21 18:30:22
