Statistical Design and Analysis of Clinical Trials: Principles and Methods (Hardcover)

Weichung Joe Shih, Joseph Aisner

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商品描述

Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods.

Teach Your Students How to Design, Monitor, and Analyze Clinical Trials

 

The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, explain the concept of different missing data processes, and describe how to analyze incomplete data by proper multiple imputations.

Turn Your Students into Better Clinical Trial Investigators

 

This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students a multidisciplinary understanding of the concepts and techniques involved in designing and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

商品描述(中文翻譯)

《臨床試驗的統計設計與分析:原理與方法》專注於臨床試驗的生物統計學部分。本書是根據作者在過去15年中教授給公共衛生和醫學學生、住院醫師和研究員的課程所編寫,展示了臨床試驗中的生物統計學如何整合許多基本科學原理和統計方法。

本書首先介紹了倫理和安全原則、核心試驗設計概念、樣本大小和功效計算的原則和方法,以及共變數分析和分層分析。接著,重點介紹了連續設計和從二期癌症試驗到三期群組序列試驗的方法,包括監測安全性、無效性和效力。作者還討論了樣本大小重新估計和自適應群組序列程序的發展,解釋了不同缺失數據過程的概念,並描述了如何通過適當的多重插補方法分析不完整數據。

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。它使學生能夠多學科地理解設計和分析各種類型試驗的概念和技術。本書平衡的家庭作業和課堂練習適合統計學、流行病學、醫學、藥學和公共衛生等專業的學生。