Fundamentals of Clinical Trials - No Cost Library
Fundamentals of Clinical Trials - 5th Edition
Author(s): Lawrence M. Friedman; Curt D. Furberg; David L. DeMets; David M. Reboussin; Christopher B. Granger
Publisher: Springer, Year: 2015
Description:
This is the fifth edition of a very popular textbook on the methods of clinical trials, written by known leaders with long and detailed experience in all fields of clinical trials. Two others have joined the three contributors of the first four editions, who add considerable expertise. A Regulatory Issues Chapter was included and the Data Tracking Chapter was split into two and extended. Many examples of present-day clinical trials have been added. There's a lot of new information on adverse incidents, adherence, methodological problems, electronic data , data sharing and international trials.
This book is intended for a clinical investigator who is interested in the design and development of a procedure for a clinical trial. Researchers and clinicians who need to objectively review the literature of published clinical trials and determine the merits of each trial as well as the consequences for patient care and treatment are also of importance. To demonstrate the basics the authors use various examples of published clinical trials.
From describing the problem to the trial closeout, the text is arranged sequentially. In order to support the clinical trial investigator, one chapter is dedicated to each of the critical areas. This include pre-defining the empirical questions to be evaluated and acceptable outcome steps, deciding the organisational framework, calculating an sufficient sample size, defining the randomization process, implementing participant assessment intervention and visit schedules, creating an interim data and security monitoring plan, detailing the final study plan and re-specification.
Although a simple introductory statistics course is helpful in optimising this book's value, a researcher or practitioner with minimal statistical experience will still find most, if not all of the chapters understandable and helpful. Although the technical material has been held to a minimum, the principles and fundamentals discussed in this text which still make the statistician useful.
This book is intended for a clinical investigator who is interested in the design and development of a procedure for a clinical trial. Researchers and clinicians who need to objectively review the literature of published clinical trials and determine the merits of each trial as well as the consequences for patient care and treatment are also of importance. To demonstrate the basics the authors use various examples of published clinical trials.
From describing the problem to the trial closeout, the text is arranged sequentially. In order to support the clinical trial investigator, one chapter is dedicated to each of the critical areas. This include pre-defining the empirical questions to be evaluated and acceptable outcome steps, deciding the organisational framework, calculating an sufficient sample size, defining the randomization process, implementing participant assessment intervention and visit schedules, creating an interim data and security monitoring plan, detailing the final study plan and re-specification.
Although a simple introductory statistics course is helpful in optimising this book's value, a researcher or practitioner with minimal statistical experience will still find most, if not all of the chapters understandable and helpful. Although the technical material has been held to a minimum, the principles and fundamentals discussed in this text which still make the statistician useful.
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