Fundamentals of Clinical Trials
by Lawrence M. Friedman, David L. Demets, Curt D. Furberg
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This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis. This show more 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 from a variety of medical disciplines 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. show lessTags
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Member Reviews
In the past century, clinical research has grown dramatically as the number of questions about healthcare has increased. The current paradigm of evidence-based medicine describes the practice of prescribing medicines based on their tested strength instead of an individual’s limited experience. Of course, to make such judgments, a rich bed of research evidence needs to exist, and this book succinctly describes how such questions are investigated for eventual dissemination.
This book’s language is succinct and clearly intended for time-strapped researchers & physicians. It does not expand on or illustrate many of the concepts but presumes a high level of clinical knowledge among its readers. The audiobook version, which I listened to, show more is also abridged and does not contain contents of the full edition.
That said, it offers a comprehensive introduction to the topic. Indeed, I wonder whether re-listening to it might provide me with some benefits because I’m sure I missed a lot in its dense presentation. Even considered are newer topics like research designs besides a randomized clinical trial (the gold standard). The audiobook format provides a proper way to listen to-and-from work or during meal breaks. show less
This book’s language is succinct and clearly intended for time-strapped researchers & physicians. It does not expand on or illustrate many of the concepts but presumes a high level of clinical knowledge among its readers. The audiobook version, which I listened to, show more is also abridged and does not contain contents of the full edition.
That said, it offers a comprehensive introduction to the topic. Indeed, I wonder whether re-listening to it might provide me with some benefits because I’m sure I missed a lot in its dense presentation. Even considered are newer topics like research designs besides a randomized clinical trial (the gold standard). The audiobook format provides a proper way to listen to-and-from work or during meal breaks. show less
This is a good introduction to the methodological and ethical considerations relevant to clinical trials in human subjects. The text discusses such issues as study design, randomization, blindness, sample size, monitoring and assessment, and the reporting and interpretation of results. Although the text is technical, it is widely supplemented with examples from actual trials, and should be accessible to anyone with a background in medicine or academia.
A great introduction to clinical trials: This book is a very good place to start for those who want to learn about the design and analysis of clinical trials. However there is a heavy emphasis on statistics - a basic knowledge of stats is essential.
Clinical trials
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Lawrence M. Friedman is Marion Rice Kirkwood Professor of Law at Stanford University.
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2 Works 107 Members
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- Languages
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