Clinical Trial Data Analysis Using R and SAS

Review of the First Edition

 

 

"The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."--Journal of Statistical Software

 

 

 

 

 

 

 

 

 

Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book's practical, detailed approach draws on the authors' 30 years' experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data.

 

 

 

 

 

 

 

 

 

What's New in the Second Edition

 

 

 

 

• Adds SAS programs along with the R programs for clinical trial data analysis.
• Updates all the statistical analysis with updated R packages.
• Includes correlated data analysis with multivariate analysis of variance.
• Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials.
• Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.

 

 

第一版評論：
「這本書的目標是填補發展中的統計方法與這些方法的應用之間的知識差距，作者成功地實現了這個目標，做得很好。我強烈推薦這本書...以例子為基礎的方法易於理解，使這本書成為許多生物統計方法的實用桌面參考。」-《統計軟體期刊》

《使用 R 和 SAS 進行臨床試驗數據分析，第二版》提供了對臨床試驗數據進行生物統計分析的詳細介紹，並使用 R 和 SAS 進行逐步實施。這本書的實用、詳細的方法來自作者在生物統計研究和臨床開發方面的30年經驗。作者使用適當的 R 套件和函數以及 SAS PROCS 逐步開發分析代碼，讓讀者能夠理解分析方法和 R、SAS 的實施，以便他們能夠使用這兩個流行的軟體包來分析自己的臨床試驗數據。

第二版的新內容包括：
- 添加了使用 SAS 程序進行臨床試驗數據分析的部分，並提供相應的 R 程序。
- 使用更新的 R 套件更新了所有統計分析。
- 包括相關數據分析和多變量方差分析。
- 將 R 和 SAS 應用於高血壓、十二指腸潰瘍、β 阻斷劑、家族性腺瘤性息肉症和乳腺癌試驗的臨床試驗數據。
- 詳細介紹了各種臨床試驗的生物統計方面，包括治療比較、時間至事件結束點、長期臨床試驗和生物等效性試驗。

Ding-Geng (Din) Chen, Ph.D., is a professor at the University of Rochester Medical Center. Dr. Chen has vast experience in

 

 

biostatistical research and clinical trial development and methodology. He has authored or co-authored more than 100 journal

 

 

 

 

publications on biostatistical methodologies and applications. He is also the co-author (with Dr. Peace) of Clinical Trial Methodology

 

 

 

 

and Clinical Trial Data Analysis Using R and a co-editor (with Drs. Sun and Peace) of Interval-Censored Time-to-Event Data: Methods

 

 

 

 

and Applications. He is a member of the American Statistical Association, chair for the STAT section of the American Public Health

 

 

 

 

Association, an associate editor of the Journal of Statistical Computation and Simulation, and an editorial board member of several

 

 

 

 

other journals.

 

 

 

 

 

 

 

 

 

Karl E. Peace, Ph.D., is the Georgia Cancer Coalition Distinguished Cancer Scholar, senior research scientist, and professor of

 

 

 

 

biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University. He is also an adjunct professor of

 

 

 

 

biostatistics at the VCU School of Medicine. Dr. Peace is a reviewer or editor of several journals, the founding editor of the Journal of

 

 

 

 

Biopharmaceutical Statistics, and a fellow of the American Statistical Association. He has authored or co-authored over 150 articles

 

 

 

 

and 10 books. He has received numerous awards, including the University System of Georgia Board of Regents' Alumni Hall of Fame

 

 

 

 

Award, the First President's Medal for outstanding contributions to Georgia Southern University, and distinguished meritorious service

 

 

 

 

awards from the American Public Health Association and other organizations. In 2012, the American Statistical Association created the

 

 

 

 

Karl E. Peace Award for Outstanding Statistical Contributions for the Betterment of Society.

 

 

丁耿（Din）陳博士是羅徹斯特醫學中心的教授。陳博士在生物統計研究和臨床試驗開發和方法論方面擁有豐富的經驗。他已經撰寫或合著了100多篇關於生物統計方法和應用的期刊文章。他還與Peace博士合著了《臨床試驗方法論和臨床試驗數據分析使用R》（Clinical Trial Methodology and Clinical Trial Data Analysis Using R），並與Sun博士和Peace博士共同編輯了《區間截獲時間事件數據：方法和應用》（Interval-Censored Time-to-Event Data: Methods and Applications）。他是美國統計學會的成員，是美國公共衛生協會統計學部門的主席，是《統計計算和模擬期刊》（Journal of Statistical Computation and Simulation）的副編輯，並是其他幾本期刊的編委會成員。

卡爾·E·皮斯博士是喬治亞癌症聯盟傑出癌症學者、高級研究科學家和喬治亞南方大學吉安·平·許公共衛生學院的生物統計學教授。他還是弗吉尼亞聯邦大學醫學院的生物統計學兼職教授。皮斯博士是幾本期刊的審稿人或編輯，是《生物製藥統計學期刊》（Journal of Biopharmaceutical Statistics）的創始編輯，也是美國統計學會的會士。他已經撰寫或合著了150多篇文章和10本書。他獲得了許多獎項，包括喬治亞大學系統理事會校友名人堂獎、對喬治亞南方大學的傑出貢獻的第一任校長獎章，以及美國公共衛生協會和其他組織頒發的傑出功績獎。2012年，美國統計學會設立了卡爾·E·皮斯傑出統計貢獻獎，以表彰對社會進步的優秀貢獻。