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Binding: PaperbackDewey 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 Accessories:
Browse for similar items by category: Click to Display Editorial Review: Product Description: 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. Average Rating:
 Rating: - easy to read overview of clinical trialsIf you need a quick intro into trial design that is well written and easy to understand this is a great book. It served as a nice survey of the topic. Some ares are just detailed enough other will stimulate you to look further in a more authoritative book on the topic. This allows the reader to see the concept and get a good general understanding. I have enjoyed coming back to this book again and again as each chapter is very concise. Rating: - Good book to build your fundamentalsThis book does exactly what it says in the title. Get this if you are looking to get your basic fundamentals straight in the area of clinical trials. The best part of this book is the way the chapters are lined out and how the authors explain certain concepts based on their own practical experiences and illustrating from their own studies. You do not need to read the book in order. You can read the chapters for a specific topic and there is no continuity among them. And I mean this ... Read More Rating:  - Invaluable Information and Easy to ReadOne 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 farThis 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. 
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