Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)

Book Description

Praise for the First Edition of Design and Analysis of Clinical Trials
"An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area."
-Statistical Methods in Medicine
A complete and balanced presentation now revised, updated, and expanded
As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH).
Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as:
* Clinical trials and regulations, especially those of the ICH
* Clinical significance, reproducibility, and generalizability
* Goals of clinical trials and target population
* New study designs and trial types
* Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities
Also, three entirely new chapters cover:
* Designs for cancer clinical trials
* Preparation and implementation of a clinical protocol
* Data management of a clinical trial
Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.

Customer Reviews:

Most complete reference on the topic.......2006-09-07

I own several books on clinical trials and this one is my favorite. It is biblical in its treatment of the topic and always seems to contain what my other books don't.

There are a few strengths that are particularly worth pointing out:
1) Makes many references to regulatory guidelines.
2) Excellent coverage of the various trial designs.
3) Good sample size chapter.
4) Several chapters on how to practically implement a trial.

Other options include:
-Piantodosi (Clinical Trials: methodologic perspective): my second favorite, not as comprehensive as Chow and Liu
-Freidman and DeMets (Fundamentals of Clinical Trials): a bit too superficial but very well written
-Pocock (Clinical trials: practical approach): a bit dated and superficial

The ELISA Guidebook (METHODS IN MOLECULAR BIOLOGY (PAPERBACK/SPIRAL))

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The ELISA Guidebook (METHODS IN MOLECULAR BIOLOGY (PAPERBACK/SPIRAL))
John R. Crowther
Manufacturer: Humana Press
ProductGroup: Book
Binding: Paperback

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ASIN: 0896037282

Book Description

John R. Crowther provides todayÃs premier practical guide to the understanding and application of ELISA. Updating and greatly expanding his widely appreciated earlier publication, ELISA Theory and Practice (1995), this important work introduces chapters on such major new topics as checkerboard titrations, quality control of testing, kit production and control, novel monoclonal antibodies, validation of assays, statistical requirements for data examination, and epidemiological considerations. With its numerous worked examples, detailed instructions, and extensive illustrations, The ELISA Guidebook offers a powerful synthesis of all the basic concepts and practical experimental details investigators need to understand, develop, and apply the new ELISA methodology successfully in day-to-day basic and clinical research.

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GALP Regulatory Handbook
Sandy Weinberg
Manufacturer: CRC
ProductGroup: Book
Binding: Hardcover

Quality Control | Management & Leadership | Business & Investing | Subjects | Books

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ASIN: 1566700256

Book Description

The GALP Regulatory Handbook is an easy-to-use manual to assist laboratories in applying the Good Automated Laboratory Practice guidelines published by the Environmental Protection Agency in 1990. The proliferation of computerized data collection has resulted in new problems of corruption, loss, and inappropriate modification in data provided to the EPA. The EPA published its GALP guidelines to aid laboratories replacing manual operations with computer technology. The eight chapters of this handbook provide a "how-to" framework for complying with those guidelines. The book looks at the extent and seriousness of those control issues for automated data collection systems, the intent of the GALPs in solving and preventing those problems, and the implementation guidelines that can help laboratory management maintain the compliance and quality that are fundamental to effective operation.

Group Sequential Methods With Applications To Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)

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clear coverage for practicing biostatisticians

Group Sequential Methods With Applications To Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)
Christopher Jennison
Manufacturer: Chapman & Hall/CRC
ProductGroup: Book
Binding: Hardcover

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Analysis of Clinical Trials Using SAS: A Practical Guide
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ASIN: 0849303168

Book Description

Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

Customer Reviews:

clear coverage for practicing biostatisticians.......2000-06-28

Advances in the theory of repeated significance testing in the 1980s and 1990s has made sequential methods practical by identifying stopping rules for data collected sequentially but in groups. This material is now used to plan interim analyses and both safety and efficacy group sequential trials for clinical trials. This text provides for the first time thorough coverage of these advances with suitable references to the literature.

It should be on the bookshelf of any biostatistician who conducts clinical trials for pharmaceutical or medical device companies.

Identifying Filamenytous Fungi: A Clinical Laboratory Handbook
Average customer rating:

Great resource for help in identifying fungi

Identifying Filamenytous Fungi: A Clinical Laboratory Handbook
Guy St-Germain
Manufacturer: STAR PUBLISHING COMPANY
ProductGroup: Book
Binding: Hardcover

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ASIN: 0898631777

Customer Reviews:

Great resource for help in identifying fungi.......2000-03-25

GREAT source for the Mycologist or student faced with the difficult task of correctly ID'ing fungi. All fungi are in alphabetical order by Genus and have illustrated color pictures of the structures and various clinical tests that will verify your ID. MUCH better than many other texts reccomended for the same purpose.

GLP Essentials: A Concise Guide to Good Laboratory Practice, Second Edition (5-pack_

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Glp Essentials: A Concise Guide to Good Laboratory Practice

GLP Essentials: A Concise Guide to Good Laboratory Practice, Second Edition (5-pack_
Milton A. Anderson
Manufacturer: Informa Healthcare
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Binding: Paperback

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Good Laboratory Practice: The Why and the How
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ASIN: 1574911384

Book Description

Concise and easy to follow, this book explains the implementation of Good Laboratory Practices. The second edition of a standard reference, GLP Essentials identifies and describes the required elements of managing a scientific study including its planning, performance, reporting, and monitoring. A brief, informative discussion of the historical development of GLPs and the rationale for establishing these requirements in the rapidly expanding scientific research and regulatory environment are also included. Written especially for readers involved in ensuring the integrity of their scientific documentation, this book is useful for group and individual training needs.

Customer Reviews:

Glp Essentials: A Concise Guide to Good Laboratory Practice .......2005-08-05

For the cost of this book, I expected something of value. This skinny little notebook is an example of pay-by-the-word. If you are looking for explanation of regulatory intent, critical inputs, and examples of methodology, this is not the book for you.

Duncan and Prasse's Veterinary Laboratory Medicine: Clinical Pathology

Average customer rating:

A continous list
Excellent book

Duncan and Prasse's Veterinary Laboratory Medicine: Clinical Pathology
Kenneth S. Latimer
Manufacturer: Iowa State Press
ProductGroup: Book
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ASIN: 0813820707

Book Description

Duncan and Prasse 's Veterinary Laboratory Medicine provides readers with an excellent overview of veterinary clinical pathology. The new edition retains its elegantly simple outline format and section organization (physiology, evaluation methods, disorders, and appropriate clinical cases), enabling readers to quickly identify key words, ideas and information in the text. Each chapter is followed by a current reference list, primarily from referred professional journals.The fourth editionapplies a problem-solving approach to interpretation of laboratory data.covers dogs, cats, horses, domestic ruminants, pigs, and companion birds.instructs veterinary students and practitioners in the proper interpretation of clinical laboratory data in order to form a list of differential diagnoses or to make a definitive diagnosis.emphasizes the mechanism or pathophysiology of the various abnormalities rather than specific diseases.adds and refines case studies to illustrate many of the concepts in interpretation of laboratory dataincludes excellent high resolution color photomicrographs and easy-to-understand tables and figures.Duncan and Prasse 's Veterinary Laboratory Medicine belongs in the library of every practitioner, technologist, and clinical laboratory as a quick reference guide. As a textbook, Duncan and Prasse 's Veterinary Laboratory Medicine is also an excellent beginning reference for students of veterinary medicine and veterinary technology

Customer Reviews:

A continous list.......2007-01-15

Altough complete, updated and deep covering most of the aspect of clinical pathology, exposition of the matter is done in the list form, like a "things to buy" note. It looks like a student's lesson note and the subject is not treated in the usual way a book does, as say with sensed phrases that correlate one to the next following a logical thread. It is more a manual than a book and it is something that is impossible to read one paragraph after the other, and even harder to remember. Anyway it carries a lot of useful information and helped me whenever i needed.

Excellent book.......2005-09-01

In my opinion, the best veterinary clinical pathology book. Great easy to read format. Consise, but providing more than just the basics. Great cases studies in the back that review topics.

Chemical Principles in the Laboratory (Brooks/Cole Laboratory Series for General Chemistry)

Average customer rating:

Good introductory chemistry lab book

Chemical Principles in the Laboratory (Brooks/Cole Laboratory Series for General Chemistry)
Emil Slowinski , Wayne C. Wolsey , and William L. Masterton
Manufacturer: Brooks Cole
ProductGroup: Book
Binding: Spiral-bound

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Succeed in chemistry with CHEMICAL PRINCIPLES IN THE LABORATORY! Clear, user-friendly, and direct, this lab manual provides you with the tools you need to successfully complete lab experiments and lab reports. Analyzing the data you observe in the lab sessions is easy with the Advance Study Assignments, found throughout the manual, that give you extra practice with processing data through sample questions.

Customer Reviews:

Good introductory chemistry lab book.......2000-02-26

This book uses removable pages as prelabs which were very good in giving a conceptual idea of the experiments before they were done. Also, there are good flowcharts, equations for every step of the reactions, and formulas to help do the problems. All data that needs to be recorded is clearly mentioned in a form format.

Handbook of Laboratory Distillation, With an Introduction to Pilot Plant Distillation (Techniques & Instrumentation in Analytical Chemistry)

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Handbook of Laboratory Distillation, With an Introduction to Pilot Plant Distillation (Techniques & Instrumentation in Analytical Chemistry)
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Clinical Chemistry: A Laboratory Perspective

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Clinical Chemistry: A Laboratory Perspective
Wendy, Ed. Arneson
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