Handbook of Statistical Methods for Randomized Controlled Trials
暫譯: 隨機對照試驗統計方法手冊
Kim, Kyungmann, Bretz, Frank, Cheung, Ying Kuen K.
- 出版商: CRC
- 出版日期: 2021-08-23
- 售價: $9,380
- 貴賓價: 9.5 折 $8,911
- 語言: 英文
- 頁數: 620
- 裝訂: Hardcover - also called cloth, retail trade, or trade
- ISBN: 1498714625
- ISBN-13: 9781498714624
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相關主題
商品描述
Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials.
Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.
商品描述(中文翻譯)
統計概念為實驗研究提供了科學框架，包括隨機對照試驗。為了科學地設計、監控、分析並從這些臨床試驗中得出結論，臨床研究者和統計學家應該對所需的統計概念有堅實的掌握。《隨機對照試驗統計方法手冊》以邏輯順序從頭到尾呈現這些統計概念，既可以作為課程的教科書，也可以作為隨機對照試驗統計方法的參考資料。
第一部分提供了現代隨機對照試驗的簡要歷史背景，並介紹了規劃、監控和分析隨機對照試驗的核心統計概念。第二部分描述了不同類型結果的分析統計方法及用於檢驗臨床問題統計假設的相關統計分佈。第三部分描述了一些最常用的隨機對照試驗實驗設計，包括規劃中所需的樣本大小估算。第四部分描述了用於中期分析的統計方法，以監控療效和安全性數據。第五部分描述了統計分析中的重要問題，如多重檢定、亞組分析、競爭風險以及針對縱向標記和臨床結果的聯合模型。第六部分針對設計和分析中的一些選定雜項主題進行探討，包括多重分配隨機化試驗、安全性結果分析、非劣性試驗、納入歷史數據以及替代結果的驗證。
作者簡介
KyungMann Kim is Professor of Biostatistics and Statistics and Director of Clinical Trials Program, Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison. He is a former associate editor of Biometrics and an elected Fellow of the American Statistical Association, the Society for Clinical Trials, and the American Association for Advancement of Science.
Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He is also an Adjunct Professor at the Hannover Medical School (Germany) and the Medical University Vienna (Austria). He is a former editor-in-chief of Statistics in Biopharmaceutical Research. a Fellow of the American Statistical Association, and a recipient of the Susanne-Dahms-Medal from the German Region of the International Biometric Society.
Ying Kuen (Ken) Cheung is Professor of Biostatistics and Associate Dean for Faculty in the Mailman School of Public Health at Columbia University. He is a recipient of the IBM Faculty Award on Big Data and Analytics. He is a Fellow of the American Statistical Association and a Fellow of the New York Academy of Medicine.
Lisa Hampson is a Director in Statistical Methodology at Novartis.
作者簡介(中文翻譯)
金京萬 (KyungMann Kim) 是威斯康辛大學麥迪遜分校生物統計學與統計學教授及臨床試驗計畫主任。他曾擔任Biometrics的副編輯，並且是美國統計協會、臨床試驗學會及美國科學促進會的當選院士。
法蘭克·布雷茲 (Frank Bretz) 是諾華公司 (Novartis) 的傑出定量研究科學家。他同時也是德國漢諾威醫學院及奧地利維也納醫科大學的兼任教授。他曾擔任Statistics in Biopharmaceutical Research的主編，是美國統計協會的院士，並獲得國際生物統計學會德國區域的蘇珊娜·達姆斯獎章 (Susanne-Dahms-Medal)。
張英權 (Ying Kuen (Ken) Cheung) 是哥倫比亞大學梅爾曼公共衛生學院的生物統計學教授及教職副院長。他獲得IBM大數據與分析教職獎 (IBM Faculty Award on Big Data and Analytics)。他是美國統計協會的院士及紐約醫學院的院士。
莉莎·漢普森 (Lisa Hampson) 是諾華公司 (Novartis) 統計方法學部的主任。
