Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)
Average customer rating: 5 out of 5 stars
  • Most complete reference on the topic
Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)
Shein-Chung Chow , and Jen-Pei Liu
Manufacturer: Wiley-Interscience
ProductGroup: Book
Binding: Hardcover

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  1. Fundamentals of Clinical Trials Fundamentals of Clinical Trials
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ASIN: 0471249858

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:

5 out of 5 stars 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
Clinical Trials in Oncology, Second Edition
Average customer rating: 5 out of 5 stars
  • Knowing What Works in Health Care
Clinical Trials in Oncology, Second Edition
Stephanie Green , Jacqueline Benedetti , and John Crowley
Manufacturer: Chapman & Hall/CRC
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Binding: Hardcover

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

ASIN: 1584883022

Book Description

Studies that are unimpeachably thorough, non-political, unbiased, and properly designed… These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present. The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now thoroughly up-to-date review of methods and issues related to clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the major pitfalls that are seemingly inherent in these processes. This edition includes a new section that describes recent innovations in Phase I designs. Another new section on microarray data examines the challenges presented by massive data sets and describes approaches used to meet those challenges. As always, the authors use clear, lucid prose and a multitude of real-world trials as examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Although the book focuses on cancer trials, the issues and concepts are important in any clinical setting. Clinical Trials in Oncology, Second Edition works to improve the mutual understanding by clinicians and statisticians of the principles of clinical trials and helps them avoid the many hazards that can jeopardize the success of a trial.

Customer Reviews:

5 out of 5 stars Knowing What Works in Health Care.......1999-12-15

I should begin by admitting that I had the opportunity to review this little masterpiece in manuscript. Good then, it's even better now.

It's good because it informs the reader, in sober prose, how to determine what works and what doesn't in medical practice, and what's safe and what isn't. It's good because it reveals what can go wrong when anecdotes ("it worked for me!") substitute for sound research as the basis for clinical practice. And it's good because it shows how serious are the consequences of even subtle failures to observe protocols in designing and carrying out clinical trials.

It is reassuring to read of the care and precautions advocated for government-sponsored research; it is accordingly unsettling to contemplate the pressure that commercial interests (drug companies, for-profit hospitals, equipment manufacturers) might bring on researchers to cut a few corners.

After reading "Clinical Trials" I came to appreciate that case studies, longitudinal studies, and retrospective questionnaires, so frequently hyped in the press and on television, are no substitute for actual well-designed and well-executed experiments. Because you and I are different, certainly genetically and probably in other essential ways, what helps you may well harm me. Only the proper application of statistics in designing clinical trials and in analyzing data from them can distinguish what's generally valuable from what's useless (however plausible and authoritatively touted it may be). Although the authors had the good taste to reject the aphorism, usually attributed to a nameless statistician, that "if experimentation be the queen of science, then statistics stands as the guardian of the royal virtue", its pithiness may give the reader the crucial insight into why alternative modes of research are untrustworthy.

Some readers may feel disheartened to learn the truth that many, probably most, promising therapies prove, when adequately tested, worthless, and some may feel in some fuzzy way that to accept this reality is cruelly to deny hope to those who need it badly. On the contrary, this book makes it clear that to offer false hope is the ultimate cruelty, for without experimentation there can be no knowledge, and without knowledge there can be no real hope.

Notwithstanding the slightly technical nature of this book (yes, there IS a chapter with mathematics), I recommend it highly for the general reader who is interested in such topics as personal health care, alternative medicine, managed care cost containment, and the like. Buy a copy for yourself, and, if you feel philanthropic, you might consider donating a copy to your health care provider. The world would be better if doctors' waiting rooms (like hotel rooms with their Gideon Bibles) all had a copy of "Clinical Trials in Oncology" available for patients' perusal.
Handbook of Statistics in Clinical Oncology, Second Edition
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    Handbook of Statistics in Clinical Oncology, Second Edition

    Manufacturer: Chapman & Hall/CRC
    ProductGroup: Book
    Binding: Hardcover

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

    ASIN: 0824723392

    Book Description

    A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a "¼good reference book for statisticians who will be designing and analyzing cancer trials." The second edition includes over 1000 references, more than forty world-renowned contributors, and 300 equations, tables, and drawings. During the five years since publication of the first edition, there has been an explosion in the technological capabilities supporting genomic and proteomic research, which are is now firmly implanted in clinical oncology. Reflecting these developments, the second edition contains a new section devoted to analyses of high-throughput data and bioinformatics. Previous chapters of the first edition have been revised to reflect current state of the art in their respective domains. The intended audience is primarily statisticians working in cancer and more generally, in any discipline of medicine. But oncologists too will find the material accessible and will benefit from a rudimentary understanding of the fundamental concepts laid forth in each chapter. Completely revised while keeping the features that made the first edition a bestseller, this is the best single source for up-to-date statistical approaches to research in clinical medicine. More than just an update of the handbook that became the gold standard, this second edition brings you fully into the genomic era of medicine.

    Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics)
    Average customer rating: 5 out of 5 stars
    • Clinical Trials: A Methodologic Perspective Second Edition
    • presents clinical trials issues and methodology clearly
    • The best start in clinical trial
    • Most up-to-date and thorough cover of Clinical Trials
    Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics)
    Steven Piantadosi
    Manufacturer: Wiley-Interscience
    ProductGroup: Book
    Binding: Hardcover

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    5. Analysis of Clinical Trials Using SAS: A Practical Guide Analysis of Clinical Trials Using SAS: A Practical Guide

    ASIN: 0471727814

    Book Description

    Learn rigorous statistical methods to ensure valid clinical trials

    This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions.

    The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and medical and statistical professionals involved in clinical trials. The Second Edition greatly expands its coverage, ranging from statistical principles to controversial topics, including alternative medicine and ethics. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First Edition will discover completely new chapters, including:

    Each chapter is accompanied by a summary to reinforce the key points. Revised discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge, and updated references are provided to direct readers to the most recent literature.

    This text distinguishes itself with its accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research. Readers learn to conduct clinical trials that produce valid qualitative results backed by rigorous statistical methods.

    Customer Reviews:

    5 out of 5 stars Clinical Trials: A Methodologic Perspective Second Edition.......2007-05-29

    This is an excellent book. It outlines the important issues of clinical trials well. It is understandable and thorough. A must for anyone who is interested in actually doing trials. Not a good book for a brief, superficial overview.

    5 out of 5 stars presents clinical trials issues and methodology clearly.......2000-09-07

    This book is very unique. Basic statistical concepts are clearly presented but only those concepts that are important in clinical trials. The author presents all the issues with clinical trials including ethical issues with some historical perspective. Principles of randomization and statistical design are clearly presented. It offers discussion of Bayesian techniques and meta-analyses, cross-over designs and group sequential methods (interim analyses). For statisticians doing clinical research like myself, this is a valuable reference source.

    5 out of 5 stars The best start in clinical trial.......2000-05-23

    The amount of knowledge and the scope of this book are the exact need for the first contact with clinical trials. Yet, it is not a simple or superficial text. Instead, it not only will guide the reader through the basics of trials (and there is so much that is not basic in it) but the author points the reader to hundreds of papers and books that are landmarks. I regard this book itself as one of these landmarks!

    5 out of 5 stars Most up-to-date and thorough cover of Clinical Trials.......1999-01-14

    Covers many aspects of trials (particularly facets of design and analysis)not yet covered by other books, eg randomisation with minimisation, and meta-analysis of trial results. Readable, applicable, practical, good references, well structured.
    Analysis of Clinical Trials Using SAS: A Practical Guide
    Average customer rating: 4.5 out of 5 stars
    • ideal book for those analyzing clinical trials
    • Overly complicated language
    • Comprehensive and thorough
    Analysis of Clinical Trials Using SAS: A Practical Guide
    Alex Dmitrienko , Geert Molenberghs , Christy Chuang-Stein , and Walter Offen
    Manufacturer: SAS Publishing
    ProductGroup: Book
    Binding: Paperback

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    4. Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics) Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)
    5. Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics) Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics)

    ASIN: 1590475046

    Book Description

    This comprehensive guide bridges the gap between modern statistical methodology and real-world clinical trial applications. Step-by-step instructions illustrated with examples from actual trials and case studies serve to define a statistical method and its relevance in a clinical trials setting and to illustrate how to implement the method rapidly and efficiently using the power of SAS software. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials, including analysis of stratified data, incomplete data, multiple inferences, issues arising in safety and efficacy monitoring, and reference intervals for extreme safety and diagnostic measurements. Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience compiled in this book. Numerous ready-to-use SAS macros and example code are included.

    Customer Reviews:

    5 out of 5 stars ideal book for those analyzing clinical trials .......2007-08-14

    I have previously reviewed a more recent book in the SAS series "Pharmaceutical Statistics using SAS: A Practical Guide" that Dmitrienko and Chuang-Stein also edited. Both books are very similar because they provide a variety of chapters by top experts in the field. Each chapter is well written and understandable to nonstatisticians who do clinical research as well as for statisticians who can use it as a reference and guide to the appropriate techniques to handle various common situations. I highly recommend this book to anyone who analyzes clinical trials data.

    3 out of 5 stars Overly complicated language.......2006-11-30

    Good history of methods with lots of citations. Not so good for practical application. Programming language is not fully explained and results are difficult to understand and reproduce. Limited output shown. I want Ron Cody to write an "applied statistics for clinical trials" workbook.

    5 out of 5 stars Comprehensive and thorough.......2006-08-24

    This is an excellent easy to follow book, from which both statisticians and interested medical professionals can greatly benefit, I believe, because I am working with both. It has helped me a lot in my graduate project on data analysis of laboratory animal trials.
    Bayesian Approaches to Clinical Trials and Health-Care Evaluation (Statistics in Practice)
    Average customer rating: 5 out of 5 stars
    • Bayes for Health Technology Assessment
    Bayesian Approaches to Clinical Trials and Health-Care Evaluation (Statistics in Practice)
    David J. Spiegelhalter , Keith R. Abrams , and Jonathan P. Myles
    Manufacturer: Wiley
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    Binding: Hardcover

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    4. Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics) Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)
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    ASIN: 0471499757

    Book Description

    READ ALL ABOUT IT!

    David Spiegelhalter has recently joined the ranks of Isaac Newton, Charles Darwin and Stephen Hawking by becoming a fellow of the Royal Society. Originating from the Medical Research Council’s biostatistics unit, David has played a leading role in the Bristol heart surgery and Harold Shipman inquiries.  

    Order a copy of this author’s comprehensive text TODAY! 

    The Bayesian approach involves synthesising data and judgement in order to reach conclusions about unknown quantities and make predictions. Bayesian methods have become increasingly popular in recent years, notably in medical research, and although there are a number of books on Bayesian analysis, few cover clinical trials and biostatistical applications in any detail. Bayesian Approaches to Clinical Trials and Health-Care Evaluation provides a valuable overview of this rapidly evolving field, including basic Bayesian ideas, prior distributions, clinical trials, observational studies, evidence synthesis and cost-effectiveness analysis.
    Covers a broad array of essential topics, building from the basics to more advanced techniques.


    Bayesian Approaches to Clinical Trials and Health-Care Evaluation is suitable for students and researchers in medical statistics, statisticians in the pharmaceutical industry, and anyone involved in conducting clinical trials and assessment of health-care technology.

    Download Description

    The Bayesian approach involves collecting data from past experience in order to reach conclusions about future events. Bayesian methods have become increasingly popular in recent years, notably in medical research. There are a large number of books on Bayesian analysis, but very few that cover clinical trials and biostatistical applications in any capacity. There is no book available that is introductory in nature and covers such a broad array of essential topics. This book provides a valuable overview of this rapidly evolving field, not only for statisticians in the pharmaceutical industry, but also to anyone involved in conducting clinical trials and HTA work. Comprehensive coverage of Bayesian methods in medical research