Randomization, Masking, and Allocation Concealment
暫譯: 隨機化、遮蔽與分配隱蔽
Berger, Vance
- 出版商: CRC
- 出版日期: 2020-12-18
- 售價: $2,270
- 貴賓價: 9.5 折 $2,157
- 語言: 英文
- 頁數: 251
- 裝訂: Quality Paper - also called trade paper
- ISBN: 036773561X
- ISBN-13: 9780367735616
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相關主題
商品描述
Randomization, Masking, and Allocation Concealment is indispensable for any trial researcher who wants to use state of the art randomization methods, and also wants to be able to describe these methods correctly.
Far too often the subtle nuances that distinguish proper randomization from flawed randomization are completely ignored in trial reports that state only that randomization was used, with no additional information. Experience has shown that in many cases, the type of randomization that was used was flawed. It is only a matter of time before medical journals and regulatory agencies come to realize that we can no longer rely on (or publish) flawed trials, and that flawed randomization in and of itself disqualifies a trial from being robust or high quality, even if that trial is of high quality otherwise.
This book will help to clarify the role randomization plays in ensuring internal validity, and in drawing valid inferences from the data. The various chapters cover a variety of randomization methods, and are not limited to the most common (and most flawed) ones. Readers will come away with a profound understanding of what constitutes a valid randomization procedure, so that they can distinguish the valid from the flawed among not only existing methods but also methods yet to be developed.
商品描述(中文翻譯)
隨機化、盲法和分配隱蔽對於任何希望使用最先進隨機化方法的試驗研究者來說都是不可或缺的,並且也希望能夠正確描述這些方法。
在試驗報告中,經常完全忽略了區分正確隨機化與有缺陷隨機化的微妙差異,這些報告僅聲明使用了隨機化,卻沒有提供任何額外信息。經驗表明,在許多情況下,所使用的隨機化類型是有缺陷的。醫學期刊和監管機構遲早會意識到,我們不能再依賴(或發表)有缺陷的試驗,而有缺陷的隨機化本身就使試驗無法被認為是穩健或高質量的,即使該試驗在其他方面是高質量的。
本書將幫助澄清隨機化在確保內部效度和從數據中得出有效推論中的角色。各章節涵蓋了多種隨機化方法,並不僅限於最常見(且最有缺陷)的那些。讀者將深入理解什麼構成有效的隨機化程序,以便能夠區分現有方法中的有效與有缺陷之處,以及尚未開發的方法。
作者簡介
Vance W. Berger received holds a doctoral degree in Statistics from Rutgers University. His professional career has included work in the pharmaceutical industry (Janssen Research Foundation, Theradex, and some consulting for Pfizer), work in two centers of the Food and Drug Administration (Drugs and Biologics), and review work for a number of statistical and medical journals. An active researcher, Dr. Berger wrote a book on the design and analysis of randomized clinical trials (focusing on randomization methods). He has also authored numerous book chapters and scientific articles appearing in the peer-reviewed literature, and has presented numerous invited lectures on this topic. Dr. Berger was the recipient of the 2006 Gertrude Cox Award, recognizing "a statistician making significant contributions to statistical practice" by the Washington Statistical Society.
作者簡介(中文翻譯)
Vance W. Berger 擁有羅格斯大學的統計學博士學位。他的職業生涯包括在製藥業(Janssen Research Foundation、Theradex,以及為 Pfizer 提供的一些諮詢服務)工作,並在美國食品藥品監督管理局的兩個中心(藥物和生物製劑)工作,以及為多本統計和醫學期刊進行審稿。作為一名活躍的研究者,Berger 博士撰寫了一本關於隨機臨床試驗設計與分析的書籍(專注於隨機化方法)。他還撰寫了多篇書章和出現在同行評審文獻中的科學文章,並就此主題進行了多次受邀演講。Berger 博士於 2006 年獲得了 Gertrude Cox 獎,以表彰他在統計實踐方面的重大貢獻,該獎項由華盛頓統計學會頒發。