Single-Arm Phase II Survival Trial Design (Paperback)
暫譯: 單臂第二期生存試驗設計 (平裝本)

Wu, Jianrong

  • 出版商: CRC
  • 出版日期: 2023-07-24
  • 售價: $2,420
  • 貴賓價: 9.5$2,299
  • 語言: 英文
  • 頁數: 263
  • 裝訂: Quality Paper - also called trade paper
  • ISBN: 0367653494
  • ISBN-13: 9780367653491
  • 相關分類: 機率統計學 Probability-and-statistics
  • 海外代購書籍(需單獨結帳)

商品描述

Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software.

Key Features:

 

 

 

 

 

 

 

 

  • Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion.
  • Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint.
  • Illustrates trial designs by real clinical trial examples
  • Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.

商品描述(中文翻譯)

單臂第二期生存試驗設計提供了對於單臂第二期試驗設計中最常用方法的全面總結,特別是針對時間事件終點的設計。單臂第二期試驗是成功開發先進癌症藥物和治療的關鍵組成部分,尤其是在靶向治療和免疫治療中,時間事件終點通常是主要終點。大多數針對時間事件終點的單臂第二期試驗設計的檢驗統計量在商業軟體中並不可用。

主要特點:

- 全面涵蓋了單臂第二期試驗設計中最常用的時間事件終點方法。
- 提供有關第二期免疫治療試驗設計和以TTP比率為終點的第二期試驗設計的新材料。
- 通過真實臨床試驗範例來說明試驗設計。
- 包含書中提出的所有方法的R程式碼,便於進行簡單的樣本大小計算。

作者簡介

Jianrong (John) Wu is a professor in the Division of Cancer Biostatistics, Department of Internal Medicine, University of Kentucky; Biostatistics and Bioinformatics Shared Resource, Markey Cancer Center. Dr. Wu has more than 20 years' experience of designing and conducting cancer clinical trials at St. Jude Children's Research Hospital and Markey Cancer Center and has developed many novel statistical methods for designing and monitoring single-arm phase II and randomized phase III trial design with time-to-event endpoints.

作者簡介(中文翻譯)

Jianrong (John) Wu 是肯塔基大學內科系癌症生物統計學部的教授;同時也是 Markey 癌症中心的生物統計與生物資訊共享資源的成員。Wu 博士在聖猶達兒童研究醫院和 Markey 癌症中心擁有超過 20 年的癌症臨床試驗設計與執行經驗,並且開發了許多新穎的統計方法,用於設計和監控單臂第二期及隨機第三期試驗,特別是針對事件發生時間的終點。