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Fundamentals of Clinical Trials
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Binding: Paperback
Dewey Decimal Number: 615.5072
EAN: 9780387985862
Edition: 3rd
ISBN: 0387985867
Label: Springer
Manufacturer: Springer
Number Of Items: 1
Number Of Pages: 361
Publication Date: 1999-12
Publisher: Springer
Studio: Springer
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Editorial Review:
The randomized control clinical trial has become the gold standard scientific method for the evaluation of pharmaceuticals, biologics, devices, procedures and diagnostic tests. This trial design has been successfully used in both therapeutic and disease prevention trials. It is superior to alternative designs by eliminating several sources of bias which exist in those designs. This role has evolved over the past three decades in a number of disease areas including cardiology, opthalmology, cancer and AIDS. While the specifics of using the randomized control design for a specific intervention and disease may differ, the basic fundamentals still apply in developing the study protocol and operational procedures. These fundamentals still apply in developing the study protocol and operational procedures. These fundamentals include identifying the specific questions to be tested and appropriate outcome measures, determining an adequate sample size, specifying the randomization procedure, detailing the intervention with visit schedules for subject evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and determining the organizational structure. This text is structured to address the fundamentals as the protocol for a clinical trial is being developed. A chapter is devoted to each of the critical areas of a protocol to aid the clinical trial researcher. The fundamentals described in this text are based on sound scientific methodology, statistical principles and years of accumulated experience by the three authors. Collectively, the authors have been active researchers in a broad area of clinical trials including cardiology, cancer, opthalmology, diabetes, osteoporosis, AIDS, women's health and screening tests. In these studies, the authors have served as members of the steering committee responsible for developing the protocol and as members of data and safety monitoring committees. The fundamentals were proposed in the first edition published in 1981 and have not changed substantially in the later editions. However, the number of examples illustrating the fundamentals has greatly expanded base on the collective experience of the authors. This text 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 test uses numerous examples of published clinical trials from a variety of medical disciples to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity. The text assumes that the readers have only a modest formal statistical background. A basic introductory statistics course is helpful in maximizing the benefit of the text. However, a researcher or practitioner with no statistical background would still find most, if not all the chapters understandable and useful.
Customer Reviews
Average Rating: 
Rating:  - Invaluable Information and Easy to Read
One of the biggest challenges most of us have in managing a complex clinical trial is in keeping all the complexity simple. Clinical Trials have gotten longer and the number of processes, regulations, and others involved in a typical trial process has increased too.
That's why I appreciate this books approach. What separates this book from the others that I've read is that it was written by individuals who really understand the challenges and nuances of a clinical trial from experience ... Read More
Rating: - Textbook!
Have no choice. It is required as textbook for my clinical trial course. So I suppose it is good without comparison with other clinical trial books.
Rating: - Good overview so far
This book has, so far, provided a nice overview of the steps associated with clinical trial design and management. The math is pretty basic, but they do think of a lot of softer issues that are important (e.g. adequate parking is essential to participant retention). The references are quite helpful. I have not finished the book, but expect the second half to retain the quality overview that I have seen in the first half.
Rating: - Detailed introduction
Comprehensive book. Requires good understanding of basic statistics and mathematics for some chapters. However without this, it is still a great book for a solid foundation on Clinical Trial design and conduct.
Rating: - CONCISE MULTIDISCIPLINARY APPROACH
The fact that this book was designed for researchers, who are involved in experimental (clinical) trials, makes the basic knowledge of statistics essential.
Using an interactive multidisciplinary approach to investigation, this handbook embraced all aspects clinical and paraclinical survey. It is very easy-to-follow, and divulges its methodology in concise manner. "Fundamentals of Clinical Trials" is one book that will help alleviate the rigorous chores of epidemiologists. However, an ... Read More
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