PDF Ebook Fundamentals of Clinical Trials

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Fundamentals of Clinical Trials

PDF Ebook Fundamentals of Clinical Trials

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Review

“This book aims to assist investigators in improving the quality of their clinical trials and protocols by discussing fundamental concepts with examples and in-depth review of the literature. … This is a valuable resource for students, clinicians, and researchers who are interested in designing a clinical trial or in critically appraising the published literature on clinical trials.” (Pooja Sethi, Doody’s Book Reviews, December, 2015)

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From the Back Cover

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book 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 authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives.Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.  This book has been successfully used for teaching courses in clinical trial methodology.  

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Product details

Hardcover: 550 pages

Publisher: Springer; 5th ed. 2015 edition (August 30, 2015)

Language: English

ISBN-10: 9783319185385

ISBN-13: 978-3319185385

ASIN: 3319185381

Product Dimensions:

6.2 x 1.3 x 9.4 inches

Shipping Weight: 1.8 pounds (View shipping rates and policies)

Average Customer Review:

4.7 out of 5 stars

10 customer reviews

Amazon Best Sellers Rank:

#272,047 in Books (See Top 100 in Books)

Excellent book to get a better understanding regarding clinical trials. Well written. I just need to get a general understanding of what constitutes an acceptable trial so I am not sure how the information will work for someone actually conducting a trial though.

VERY GOOD!!

Dry but thorough. A must for any clinician thinking of doing clinical trials.

Very useful even though I work in marketing research, not medicine.

Very clear and detailed. Great book.

Comprehensive coverage with latest updates on the subject.

Good book

good

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Fundamentals of Clinical Trials PDF

Fundamentals of Clinical Trials PDF