Statistical Design, Monitoring, and Analysis of Clinical Trials: Principles and Methods, 2/e (Hardcover)
暫譯: 臨床試驗的統計設計、監控與分析：原則與方法，第2版（精裝本）

《臨床試驗的統計設計與分析（第二版）》專注於臨床試驗的生物統計組成部分。這一新版在各方面都進行了更新，並新增了五個章節。

本書源自作者在過去15年中教授公共衛生和醫學學生、住院醫師及研究員的課程，展示了臨床試驗中的生物統計學如何整合多種基本科學原則和統計方法。本書首先介紹倫理和安全原則、核心試驗設計概念、樣本大小和檢定力計算的原則與方法，以及協方差分析和分層分析。接著，重點討論兩階段II期癌症試驗到III期群體序列試驗的序列設計和方法，涵蓋安全性監測、無效性和有效性。作者還討論了樣本大小重新估計和自適應群體序列程序的發展，解釋不同缺失數據過程的概念，並描述如何通過適當的多重插補來分析不完整數據。

本書反映了臨床試驗的學術研究、商業發展和公共衛生方面。它使學生對設計和分析各類試驗所涉及的概念和技術有多學科的理解。本書平衡的作業和課堂練習適合於（生物）統計學、流行病學、醫學、藥學和公共衛生的學生。

Weichung Joe Shih, PhD, has been tenured professor and chair of the Department of Biostatistics, Rutgers School of Public Health, Rutgers University, New Brunswick, New Jersey, and director of Biometrics Division at the Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey. He is an elected fellow of the American Statistical Association (1996) and an elected member of the International Statistical Institute (2001). Prior to joining academia, he spent his formative years (1982-1999) at Merck Research Laboratories, Rahway, New Jersey. He served in the Advisory Board of the US FDA for reviewing new drug applications, and was associate editor of professional journals, including　Statistics in Medicine,　Controlled Clinical Trials,　Clinical Cancer Research,　Statistics in Biopharmaceutical Research, and　Statistics in Bioscience. He pioneered in the field of sample size re-estimation for clinical trials, which has evolved into the field of adaptive designs. He also first advocated the use of consistency criterion for international bridging studies, which is now adopted by the ICH guidance for global multiregional clinical trials. He has collaborated extensively with physicians in various therapeutic areas and authored numerous papers in statistical methodology in clinical trials. His research interests include adaptive designs and missing data issues. He has been honored as professor emeritus of Rutgers University since July 2019.

Joseph Aisner, MD, is a professor of medicine and a professor of environmental and occupational medicine at the Robert Wood Johnson Medical School of Rutgers University, New Brunswick, New Jersey, director of Medical Oncology Unit at the Robert Wood Johnson University Hospital, New Brunswick, New Jersey, and co-leader of the Clinical Investigations Program at the Rutgers Cancer Institute of New Jersey. He has published extensively and has served on the editorial board of multiple journals, including Journal of Clinical Oncology, Cancer Therapeutics, Medical Oncology, Clinical Cancer Research, and Hematology-Oncology Today. He is a fellow of the American College of Physicians and the American Society of Clinical Oncology. He serves on and chairs several National Data Monitoring Committees, has served on multiple National Institutes of Health (NIH) Study Sections, and has headed two National Cooperative Cancer Study Groups. His research interests include cancer clinical trials and evaluation of therapeutic interventions.

施維忠博士，為羅格斯大學公共衛生學院生物統計學系的終身教授及系主任，並擔任羅格斯癌症研究所生物統計部的主任。他是美國統計學會的當選會士（1996年）及國際統計學會的當選成員（2001年）。在進入學術界之前，他在默克研究實驗室（Merck Research Laboratories）度過了他的成長歲月（1982-1999），該實驗室位於新澤西州拉威（Rahway）。他曾在美國食品藥品監督管理局（US FDA）的諮詢委員會中擔任新藥申請的審查委員，並擔任多本專業期刊的副編輯，包括Statistics in Medicine、Controlled Clinical Trials、Clinical Cancer Research、Statistics in Biopharmaceutical Research及Statistics in Bioscience。他在臨床試驗的樣本大小重新估算領域開創了先河，該領域已演變為適應性設計。他也首次倡導在國際橋接研究中使用一致性標準，該標準現在已被國際會議（ICH）指導方針採納，用於全球多區域臨床試驗。他與各種治療領域的醫生廣泛合作，並在臨床試驗的統計方法上發表了大量論文。他的研究興趣包括適應性設計和缺失數據問題。自2019年7月以來，他被授予羅格斯大學名譽教授的榮譽。

約瑟夫·艾斯納醫學博士，為羅格斯大學羅伯特·伍德·約翰遜醫學院的內科教授及環境與職業醫學教授，並擔任羅伯特·伍德·約翰遜大學醫院的醫療腫瘤科主任，以及羅格斯癌症研究所臨床研究計畫的共同負責人。他發表了大量研究成果，並在多本期刊的編輯委員會中任職，包括Journal of Clinical Oncology、Cancer Therapeutics、Medical Oncology、Clinical Cancer Research及Hematology-Oncology Today。他是美國內科醫師學會及美國臨床腫瘤學會的會士。他在多個國家數據監測委員會中擔任委員及主席，曾在多個國立衛生研究院（NIH）研究小組中任職，並領導過兩個國家合作癌症研究小組。他的研究興趣包括癌症臨床試驗及治療介入的評估。