Design and Analysis of Clinical Trials for Predictive Medicine
暫譯: 預測醫學的臨床試驗設計與分析
Matsui, Shigeyuki, Buyse, Marc, Simon, Richard
- 出版商: CRC
- 出版日期: 2020-12-18
- 售價: $2,550
- 貴賓價: 9.5 折 $2,423
- 語言: 英文
- 頁數: 404
- 裝訂: Quality Paper - also called trade paper
- ISBN: 0367738430
- ISBN-13: 9780367738433
-
相關分類:
Machine Learning
海外代購書籍(需單獨結帳)
商品描述
Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics--from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials.
The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving.
This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.
商品描述(中文翻譯)
《臨床試驗設計與分析：預測醫學的統計指導》提供了進行預測醫學臨床試驗的統計指導。它涵蓋了與開發分子診斷和治療相關的主要臨床研究階段的統計主題——從使用DNA微陣列識別分子生物標記到在隨機臨床試驗中確認其臨床效用。
現代臨床試驗的基礎在現代生物技術和基因組學的發展之前就已經奠定。許多疾病的藥物開發現在正轉向分子靶向治療。面對這一向個性化或預測醫學演變的重大突破，臨床試驗的設計和分析方法論也在不斷演變。
本書是為這一演變做出貢獻的首批嘗試之一，為未來預測醫學臨床試驗中使用適當的統計設計和方法奠定基礎。它是臨床生物統計學家、專注於預測醫學的研究人員、臨床研究者、轉化科學家以及研究生生物統計學學生的有用資源。
作者簡介
Shigeyuki Matsui is a professor in the Department of Biostatistics at Nagoya University Graduate School of Medicine in Japan. He is also a visiting professor at the Institute of Statistical Mathematics. Dr. Matsui has served as council and nominating committee member of the International Biometric Society. He is currently council of the Biometric Society of Japan (BSJ) and editor-in-chief of the Japanese Journal of Biometrics. He is the recipient of the 2014 Award from the BSJ. Dr. Matsui is also a frequent reviewer commissioned by government and advisor to pharmaceutical companies in Japan. He holds degrees in engineering from the Tokyo University of Science in Japan.
Marc E. Buyse is the founder of the International Drug Development Institute in Louvain-la-Neuve, Belgium and of CluePoints Inc. in Cambridge, Massachusetts. He is also an associate professor of biostatistics at Hasselt University in Belgium. He was president of the International Society for Clinical Biostatistics, president of the Quetelet Society, and fellow of the Society for Clinical Trials. He worked at the European Organization for Research and Treatment of Cancer in Brussels and at the Dana Farber Cancer Institute in Boston. He holds degrees in engineering and statistics from Brussels University, management from the Cranfield School of Management in the UK, and a doctorate in biostatistics from Harvard University.
Richard M. Simon is chief of the Biometric Research Branch at the National Cancer Institute in Bethesda, Maryland. He leads a multidisciplinary group of scientists developing and applying methods for the application of genomics to cancer therapeutics. Dr. Simon is the architect of BRB-ArrayTools software used for the analysis of microarray and digital expression, copy number, and methylation data. He is the recipient of the 2013 Karl E. Peace Award for Outstanding Statistical Contributions for the Betterment of Society and is the author or coauthor of more than 450 publications.
作者簡介(中文翻譯)
松井重幸是日本名古屋大學醫學研究所生物統計學系的教授。他同時也是統計數學研究所的訪問教授。松井博士曾擔任國際生物統計學會的理事及提名委員會成員。目前，他是日本生物統計學會（BSJ）的理事及《日本生物統計學期刊》的主編。他是2014年BSJ獎的獲得者。松井博士也是日本政府委託的常任審稿人及製藥公司的顧問。他擁有日本東京科學大學的工程學位。
馬克·E·布伊斯是比利時盧萬拉紐夫的國際藥物開發研究所及美國麻薩諸塞州劍橋的CluePoints Inc.的創始人。他同時也是比利時哈塞爾特大學的生物統計學副教授。他曾擔任國際臨床生物統計學會的會長、奎特萊特學會的會長，以及臨床試驗學會的研究員。他曾在布魯塞爾的歐洲癌症研究與治療組織及波士頓的達納法伯癌症研究所工作。他擁有布魯塞爾大學的工程學及統計學學位、英國克蘭菲爾德管理學院的管理學學位，以及哈佛大學的生物統計學博士學位。
理查德·M·西蒙是美國馬里蘭州貝塞斯達國家癌症研究所生物統計研究部的主任。他領導一個多學科的科學家團隊，開發並應用基因組學在癌症治療中的方法。西蒙博士是BRB-ArrayTools軟體的設計者，該軟體用於微陣列和數位表達、拷貝數及甲基化數據的分析。他是2013年卡爾·E·皮斯社會貢獻卓越統計貢獻獎的獲得者，並且是450多篇出版物的作者或合著者。
