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A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series)
 
 
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A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) [Hardcover]

Phillip I. Good (Author)
5.0 out of 5 stars  See all reviews (2 customer reviews)


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Hardcover, August 8, 2002 --  
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There is a newer edition of this item:
A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) 5.0 out of 5 stars (2)
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Book Description

0471226157 978-0471226154 August 8, 2002 1
This engaging and non-technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon-laden treatment of other books, A Manager’s Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks.
  • Offers an executive level presentation of managerial guidelines as
    well as handy checklists accompanied by extracts from submitted
    protocols
  • Includes checklists, examples, and tips, as well as a useful appendix on available software
  • Covers e-submissions and use of computers for direct data
    acquisition
  • Incorporates humorous yet instructive and true anecdotes to
    illustrate common pitfalls


Editorial Reviews

Review

"...readable, informative and at times witty...never stops being concise and well written...a book worth a read..." (Statistics in Medicine, Vol 23(3), 15 February 2004)

"The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." (Technometrics, Vol. 45, No. 1, February 2003)

"This book is must-have reading for anyone in the business..." (Clinical Chemistry, Vol. 49, No. 7, 2003)

From the Back Cover

The first practical guide to computer-assisted clinical trials written without use of technical jargon, A Manager’s Guide to the Design and Conduct of Clinical Trials provides a comprehensive primer for prospective managers covering every critical issue, including study design, organization, management, and analysis, as well as recruitment, reporting, software, and monitoring.

This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip I. Good incorporates humorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book’s three sections–"Plan," "Do," and "Check"–include the following material:

  • Staffing for success
  • Designing trials and determining sample size
  • Budgeting
  • Exception handling
  • Recruiting and retaining patients and physicians
  • Data management
  • Monitoring the trials
  • Data analysis and review

Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager’s Guide to be an indispensable resource.


Product Details

  • Hardcover: 248 pages
  • Publisher: Wiley-Liss; 1 edition (August 8, 2002)
  • Language: English
  • ISBN-10: 0471226157
  • ISBN-13: 978-0471226154
  • Product Dimensions: 9.5 x 6.4 x 0.9 inches
  • Shipping Weight: 1.2 pounds
  • Average Customer Review: 5.0 out of 5 stars  See all reviews (2 customer reviews)
  • Amazon Best Sellers Rank: #1,652,799 in Books (See Top 100 in Books)

More About the Author

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4 of 15 people found the following review helpful:
5.0 out of 5 stars Recommended Book, January 22, 2003
By A Customer
This review is from: A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) (Hardcover)
"The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." (Technometrics, Vol. 45, No. 1, February 2003)
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1 of 16 people found the following review helpful:
5.0 out of 5 stars Must-Have Reading, September 3, 2003
By A Customer
This review is from: A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) (Hardcover)
"This book is must-have reading for anyone in the business..." (Clinical Chemistry, Vol. 49, No. 7, 2003)
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Inside This Book (learn more)
First Sentence:
THE ESSENCE OF THE GUIDELINES presented here-start with your reports, enter the data directly into the computer, validate on entry, and monitor your results continuously-first appeared in a newsletter I edited in the mid 1980s. Read the first page
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
clinical research monitor, binary restenosis, ineligible patients, data entry software, medical monitor, regulatory liaison, case report forms, data management software, patient recruitment, treatment code, site coordinator, data entry screens, permutation tests, recurrent ischemia, research monitors, protocol violations
Key Phrases - Capitalized Phrases (CAPs): (learn more)
New York, United States, Financial Times, Raven Press
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