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「电子书」Fundamentals of Clinical Trials 临床试验基础 PDF

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这是一本非常成功的临床试验方法学教科书的第五版,由在临床试验各领域具有长期而丰富经验的公认的领导者撰写。在前四版的三位作者的基础上,又有两位作者加入,他们增加了丰富的专业知识。与第四版相比,大部分章节都做了较大的修订。增加了一章关于监管问题的内容,数据监测一章被拆成两章并进行了扩充。增加了许多当代临床试验的例子。在不良事件、依从性、分析中的问题、电子数据、数据共享和国际试验等方面有很多新的材料。


本书的读者对象是对设计临床试验和制定方案感兴趣的临床研究人员。本书对于那些必须对已发表的临床试验文献进行批判性评价,并评估每项试验的优点以及对患者护理和治疗的影响的研究人员和从业人员也有价值。作者用大量已发表的临床试验实例来说明基本原理。


全书从定义问题到试验结束依次组织。每一个关键领域都有一章,以帮助临床试验研究者。这些领域包括预先明确要测试的科学问题和适当的结果测量方法,确定组织结构,估计足够的样本量,明确随机化程序,实施干预和访问计划以进行参与者评估,建立中期数据和安全监测计划,详细说明最终分析计划,并根据预先指定的目标报告试验结果。


虽然基本的统计学入门课程有助于最大限度地受益于本书,但统计学背景有限的研究人员或从业人员仍然会发现大部分甚至全部章节都是可以理解和帮助的。虽然技术性材料已被保持在最低限度,但统计人员可能仍然会发现本文所介绍的原则和基础知识是有用的。本书已成功地用于临床试验方法学课程的教学。 


This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials.


This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals.


The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives.


Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology.  


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