Sample Size Calculations in Clinical Research
暫譯: 臨床研究中的樣本大小計算
Chow, Shein-Chung, Shao, Jun, Wang, Hansheng
- 出版商: CRC
- 出版日期: 2020-09-30
- 售價: $2,200
- 貴賓價: 9.5 折 $2,090
- 語言: 英文
- 頁數: 510
- 裝訂: Quality Paper - also called trade paper
- ISBN: 0367657767
- ISBN-13: 9780367657765
海外代購書籍(需單獨結帳)
相關主題
商品描述
Praise for the Second Edition:
"... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics
"This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." - Journal of the Royal Statistical Society
Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation.
Features:
- Compares the relative merits and disadvantages of statistical methods for sample size calculations
- Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages
- Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women's health
- Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches
This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.
商品描述(中文翻譯)
對於第二版的讚譽：
「...這是一本有用且全面的幾乎涵蓋所有可能樣本大小公式的彙編。強大的組織結構和精確定義的公式將幫助任何設計研究的研究者。」 - 《生物統計學》
「這本令人印象深刻的書包含了在各種情境下計算樣本大小的公式。對於定量、二元和事件發生時間的單樣本研究和雙樣本比較進行了全面的涵蓋，並針對檢驗相等性、非劣性和等效性提供了單獨的樣本大小公式。許多不太熟悉的主題也得到了涵蓋 ...」 - 《皇家統計學會期刊》
《臨床研究中的樣本大小計算，第三版》介紹了在臨床研究和開發的各個階段進行樣本大小計算的統計程序。這本書全面且統一地呈現了統計概念和實際應用，包括對當前和新興臨床問題、法規要求以及最近開發的樣本大小計算統計方法的良好平衡總結。
特點：
- 比較樣本大小計算的統計方法的相對優缺點
- 解釋樣本大小計算的公式和程序如何在各種臨床研究和開發階段中使用
- 提供來自幾個治療領域的實際案例，包括心血管醫學、中樞神經系統、抗感染醫學、腫瘤學和婦女健康
- 提供劑量反應研究、微陣列研究和貝葉斯方法的樣本大小計算
這一新版在各方面都進行了更新，包含許多新章節，並新增五個關於新興主題的章節：兩階段無縫自適應設計、集群隨機試驗設計、零膨脹泊松分佈、極低發生率的臨床試驗以及臨床試驗模擬。
作者簡介
Shein-Chung Chow, PhD, is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also an adjunct professor at Duke-National University of Singapore Graduate Medical School, an adjunct professor at North Carolina State University, and founding director of the Global Clinical Trial and Research Center in Tianjin, China. He is editor-in-chief of the Journal of Biopharmaceutical Statistics and editor-in-chief of the Chapman & Hall/CRC Biostatistics Series. He is the author or co-author of more than 250 papers and 24 books, including Adaptive Design Methods in Clinical Trials, Second Edition, Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, and Controversial Statistical Issues in Clinical Trials. A fellow of the ASA and member of the ISI, Dr. Chow has received the ASA Chapter Service Recognition Award, the DIA Outstanding Service Award, and the ICSA Extraordinary Achievement Award.
Dr. Lokhnygina is an Assistant Professor of Biostatistics and Bioinformatics at Duke University and a faculty member at Duke Clinical Research Institute. Her primary research interests are in statistical methods for multicenter clinical trials, particularly in application to cardiovascular and diabetes research.
作者簡介(中文翻譯)
周世忠博士是杜克大學醫學院生物統計與生物資訊系的教授。周博士同時也是新加坡國立大學杜克研究生醫學院的兼任教授、北卡羅來納州立大學的兼任教授，以及中國天津全球臨床試驗與研究中心的創始主任。他是《生物製藥統計期刊》的主編，以及Chapman & Hall/CRC生物統計系列的主編。他是超過250篇論文和24本書籍的作者或合著者，包括《臨床試驗中的自適應設計方法（第二版）》、《藥物和臨床開發中的自適應設計手冊》以及《臨床試驗中的爭議統計問題》。作為美國統計協會（ASA）的會士及國際統計學會（ISI）的成員，周博士曾獲得ASA分會服務表彰獎、DIA傑出服務獎和ICSA卓越成就獎。
洛赫尼基娜博士是杜克大學生物統計與生物資訊的助理教授，也是杜克臨床研究所的教職員。她的主要研究興趣在於多中心臨床試驗的統計方法，特別是在心血管和糖尿病研究的應用。
