Book 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.
Customer Reviews:
Good overview so far.......2007-02-09
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.
Detailed introduction.......2005-08-02
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.
CONCISE MULTIDISCIPLINARY APPROACH.......2003-01-30
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 advanced or versatile researcher may complain that some of the information in it are too summarized.
Good intro textbook.......2003-01-04
I used this book for a class that I took last semester on clinical trial.
The authors do a good job of giving a good overview of the topics of interest, in particular: sample size calculation, use of DSMBs, trial design, choice of endpoints, randomization and issues in data analysis.
The chapters on sample size estimation and use of safety monitoring boards are quite heavy on the statistics. If you've never had an intro class in statistics, then these chapters may be way over your head.
There are a few topics that the authors didn't cover so well that I thought should have been more prominent: Choice of primary endpoints in FDA trials, general requirements of the FDA and regulatory information in general, the calculations of meta-analyses.
Overall I am quite happy with this book and will keep it on my shelf as a good reference.
A great introduction to clinical trials.......2001-08-17
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.
Average customer rating:
- The backwards book for biostatistics
- My Prof had trouble understanding the book!
- Poor layout
- Awesome Biostats Primer!
- Fundamentals of Biostatistics by Rosner
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Fundamentals of Biostatistics (with CD-ROM)
Bernard Rosner
Manufacturer: Duxbury Press
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ASIN: 0534418201 |
Book Description
FUNDAMENTALS OF BIOSTATISTICS (WITH CD-ROM) leads you through the methods, techniques, and computations necessary for success in the medical field. Every new concept is developed systematically through completely worked out examples from current medical research problems.
Customer Reviews:
The backwards book for biostatistics.......2007-03-23
At the time I was taking bio-statistics for my MPH at Harvard School of Public Health, a friend was taking a different class using this book. I ended up buying it, but only as a reference. Althought the material is all here, the organization is scrambled with theory intermixed with the example that starts the topic discussion - some may like this, but personally it drives me crazy. At the end of the semester, I had a wonderful grasp of statistics, and my friend was pulling his hair out. One real plus of this book is that the index includes the clinical examples that generate the discussion, so I do use this book as a reference for "like-problems".
My Prof had trouble understanding the book!.......2006-12-18
My prof had us buy this book for an intro stats class for grad school. She didn't know how good it would be, but thought it applied to our health policy program. This book was not very good. At one point even our prof said she did not like the book and thought the practice questions were unclear at times. Unless your prof forces you to use this book, I would look at easier books (this is not good for a basic stats class). We also used SAS and this book wasn't any help with that portion of the course. It was not worth the $110 price tag. If you are a prof looking for a stats book, please don't select this one (the price alone is crazy).
Poor layout.......2006-11-10
I was assigned this text for my biostatistics class. Unfortunately, it is a poorly designed textbook, as everything is 'backwards'. Rosner gives examples before he introduces the material; he derives formulas before giving the real equation to use.
The only good thing about the text are the summaries included on the CD-rom. I have decided to read these instead of the actual text, because they are straightforward and leave out extraneous material.
Awesome Biostats Primer!.......2006-02-01
I'm currently an undergraduate student at Univ. South Florida majoring in social work (BSW). I am also doing a math minor because I plan on going on to graduate school in a dual program, social work (MSW) and public health-biostatistics (MSPH).
Having read through the first five chapters (can't put the book down), I found this textbook gives just enough information on the subject matter without going into math theory. Afterall, biostatistics is an applied field not theoretical.
This is a perfect textbook to get primed in the field of biostatistics. I cannot wait to finish this text and learn more theory and history of the many facets that biostatistics has to offer as it relates to the behavioral sciences.
The one drawback about the book is that it does not offer much on how to use a statistical analysis software package, rather it assumes knowledge in this area and just provides the data sets used in the book. A supplimental workbook for this text on the after mentioned topic would be wonderful.
Fundamentals of Biostatistics by Rosner.......2005-11-17
This is an easy-to-read volume on the implementation of statistics for medicinal applications. The author describes the following:
- measures of location i.e. medium white blood counts
- properties of the standard deviation and special case analyses
- graphic methods
- laws of probability
- gynecological problems
- demographic problems and inference
- hypothesis testing and confidence interval analysis
- goodness of fit for regression problems
This work would have a wide audience of readers throughout the
medical world. It is priced reasonably for consumer-conscious
purchasers. The author provides a rendition geared to practitioners. Much of the work is crafted for technical
analysis by professionals , as opposed to theoretical mathematics. For instance, the volume is useful to confirm
medical hypotheses within predefined confidence intervals.
Some reviewers have indicated that the later part of the text
is complicated. For instance, the t-distribution and estimation
techniques may require a simpler explanation. In college, I took
nine reasonably rigorous courses in higher mathematics.
During those courses, I found that the Schaum's Outlines were
good in the areas of calculus, differential equations,
linear algebra, probability and statistical inference. Each
outline provided nearly 1000 solved problems with both theory
and practice explained comprehensively. Students of the Rosner
text would be helped immensely by the Schaum's Outline Series.
This acquisition is still quite good for the price charged.
Book Description
In recent years many introductory textbooks on clinical trial methodology have been published, some of which are excellent, in addition to a very extensive specialist literature. Nevertheless, here is a new book on methods and issues in clinical research. The objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research.
The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a condition capable of provoking such impairment over time, can be universally accepted as such (e.g. a cancer or a bone fracture) or perceived as such only by limited groups of individuals in a given cultural context (e.g. hair loss or weight gain). The course of the disease that ones wishes to change can be the one with no intervention or, more frequently, the one observed with the available treatment. The evaluation of the effect of a treatment on the course of a disease is a lengthy process, which progresses in increasingly complex stages.
A detailed coverage of the logistic, administrative and legal aspects of clinical research is outside the scope of this book. However, throughout the book we keep reminding the reader of these aspects because, as already mentioned, we firmly believe they have a crucial role in determining the success of a study. The history of clinical research is paved with relics of studies started with great pomp, riding great ideas and great hopes, which drowned miserably because of inadequate logistical preparation. In our experience, the excessive complexity of a clinical trial is the single most frequent cause of failure: the study is perfect on paper, but impossible to implement by patients and staff alike. The distance between the principal investigators and the reality of clinical research in its day-to-day practice is often the main cause of such disasters. We warmly encourage everyone involved in clinical research to get involved in the logistics of a study, learning from colleagues responsible for its practical conduct (clinical research associates, data managers, etc.) and to take part, in person, in the practical implementation of a trial before attempting to design a study protocol.
The book ends with a brief description of the drug development process and to the phases of clinical development.
Book Description
Statistical Monitoring of Clinical Trials: Fundamentals for Investigators introduces the investigator and statistician to monitoring procedures in clinical research. Clearly presenting the necessary background with limited use of mathematics, this book increases the knowledge, experience, and intuition of investigations in the use of these important procedures now required by the many clinical research efforts.
The author provides motivated clinical investigators the background, correct use, and interpretation of these monitoring procedures at an elementary statistical level. He defines terms commonly used such as group sequential procedures and stochastic curtailment in non-mathematical language and discusses the commonly used procedures of Pocock, O’Brien–Fleming, and Lan–DeMets. He discusses the notions of conditional power, monitoring for safety and futility, and monitoring multiple endpoints in the study. The use of monitoring clinical trials is introduced in the context of the evolution of clinical research and one chapter is devoted to the more recent Bayesian procedures.
From the reviews:
"The author has a wealth of experience in this area and this is demonstrated throughout the text with relevant poignant examples."
Short Book Reviews of the ISI, June 2006
Book Description
With continued progress in mapping and sequencing of the human genome, and increasing recognition of the role of genes in disease etiology, there is a need for a more sophisticated approach to the investigation of the causes of complex chronic diseases. This text integrates the principles, methods and approaches of epidemiology and genetics in the study of disease etiology. After a brief historical overview of genetics and epidemiology and their gradual rapprochement, the authors define the central theme of genetic epidemiology as the study of the role of genetic factors and their interaction with environmental factors in the occurrence of disease in populations. They describe fundamental research strategies of genetic epidemiology including population and family studies. Among the former are the study of the distribution of genetic traits and the role of nonspecific genetic indicators (such as inbreeding and admixture) in the occurrence of diseases. Among the latter are the analysis of familial aggregation of disease and its causes by epidemiologic methods as well as techniques of formal genetic analysis (variance components, segregation and linkage analysis). Finally, the authors discuss the increasing applications of genetic epidemiology in preventive medicine, public health surveillance, and the emerging ethical issues regarding use of genetic information in society.
Customer Reviews:
unique, comprehensive approach to genetic epidemiology.......2000-06-03
the authors present an epidemiologic approach to the study of genetic and environmental factors in health and disease. The book is comprehensive and lucid -- and captivatingly simple. I find myself going back to sections of the back even years after having read it the first time. One suggestion: the section on linkage analysis is, in my view, not easy to read and digest as the rest of the book. If you look for texts on linkage, other choices may serve you best. For everything else (on the epidemiologic approach to gene-environment interactions), I know of no better book. It should be integrated with a review paper or two on more recent techniques (TDT, case-triads, case-only studies) that have been developed after the publication of the book. This book is in my library to stay.
Difficult. Not a great stand alone textbook........1997-06-16
There are some useful nuggets for graduatre students, but this is a very difficult book to use as a primary textbook for learning methods. It is also somewhat out of date
Book Description
One of the most challenging issues for clinical trial investigators, sponsors, and regulatory officials is the interpretation of experimental results that are composed of the results of multiple statistical analyses. These analyses may include the effect of therapy on multiple endpoints, the assessment of a subgroup analysis, and the evaluation of a dose-response relationship in complex mixtures. Multiple Analyses in Clinical Trials: Fundamentals for Clinical Investigators is an essentially nonmathematical discussion of the problems posed by the execution of multiple analyses in clinical trials. It concentrates on the rationale for the analyses, the difficulties posed by their interpretation, easily understood solutions, and useful problem sets. This text will help clinical investigators understand multiple analysis procedures and the key issues when designing their own work or reviewing the research of others. This book is written for advanced medical students, clinical investigators at all levels, research groups within the pharmaceutical industry, regulators at the local, state, and federal level, and biostatisticians. Only a basic background in health care and introductory statistics is required. Dr. Lemuel A. Moyé, M.D., Ph.D. is a physician and Professor of Biometry at the University of Texas School of Public Health. He has been Co-Principal Investigator of two multinational clinical trials examining the role of innovative therapy in post myocardial infarction survival (SAVE) and the use of cholesterol reducing agents in post myocardial infarction survival in patients with normal cholesterol levels (CARE). He has authored over one hundred articles in journals such as the Journal of the American Medical Association, the New England Journal of Medicine, Statistics in Medicine, and Controlled Clinical Trials.
Average customer rating:
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Fundamentals of biometry
L. N Balaam
Manufacturer: Wiley
ProductGroup: Book
Binding: Paperback
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ASIN: 047004571X |
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Fundamentals of Biostatistical Inference (Statistics: a Series of Textbooks and Monogrphs)
Le
Manufacturer: CRC
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Binding: Hardcover
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ASIN: 0824786742 |
Book Description
A textbook for a one-semester graduate course in the mathematical foundations of biostatistics, the prerequisite being a year of undergraduate calculus, and a course in basic statistical or biostatistical methods. Annotation copyright Book News, Inc. Portland, Or.
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