Oncology Clinical Trials: Successful Design, Conduct and Analysis
暫譯: 腫瘤學臨床試驗:成功的設計、執行與分析

Wm. Kevin Kelly DO (Editor), Susan Halabi PhD (Editor), Richard Schilsky MD (Foreword)

  • 出版商: Demos Medical Publis
  • 出版日期: 2009-12-22
  • 售價: $7,100
  • 貴賓價: 9.5$6,745
  • 語言: 英文
  • 頁數: 450
  • 裝訂: Hardcover
  • ISBN: 1933864389
  • ISBN-13: 9781933864389
  • 無法訂購

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商品描述

Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial.

Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials.

Oncology Clinical Trials features:
  • A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology
  • Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives
  • Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis
  • Real-life examples from reported clinical trials included throughout
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商品描述(中文翻譯)

臨床試驗是新藥和設備在癌症檢測、監測、預防和治療方面進步的引擎。一個構思良好、設計周密且高效執行的臨床試驗可以產生改變臨床實踐的結果,將新的腫瘤學藥物和診斷工具推向市場,並擴展當代對癌症生物學的思考視野。相反,一個執行不佳的試驗對於推進該領域或指導臨床實踐幫助不大,消耗珍貴的臨床和財務資源,並挑戰研究人員與自願付出時間和努力以造福未來病人的志願者之間的倫理契約的有效性。本書《腫瘤學臨床試驗》由腫瘤科醫生、研究人員、生物統計學家、臨床研究管理者以及業界和FDA代表撰寫,為早期和資深的腫瘤學研究者提供了一本成功設計、執行和分析腫瘤學臨床試驗的綜合指南。

《腫瘤學臨床試驗》涵蓋了如何制定研究問題、選擇研究人群、I、II和III期試驗的研究設計、毒性監測、數據分析和報告、基因組學的使用、成本效益分析、系統性回顧和元分析等多個議題。書中還包括了許多在文獻中報導的臨床試驗實際缺陷的例子。本書從頭到尾討論臨床試驗,重點關注臨床試驗的開發、設計和分析中的實際案例。

《腫瘤學臨床試驗》的特色包括:
- 一個系統性的指南,涵蓋腫瘤學臨床試驗設計、執行、分析和報告的各個方面
- 來自腫瘤科醫生、研究人員、生物統計學家、臨床研究管理者以及業界和FDA代表的貢獻
- 腫瘤學試驗中的熱門話題,包括多臂試驗、元分析和自適應設計、基因組學的使用以及成本效益分析
- 書中包含的報導臨床試驗的實際案例