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This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting.
Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards.
This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous 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"-includethe following material:
* Should the trials be conducted?
* Put it in the computer and keep it there
* Staffing for success
* Designing trials and determining sample size
* Budgeting
* Recruiting and retaining patients and physicians
* Data management
* Monitoring the trials
* Data analysis
* After action review
* Exception handling
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 an indispensable resource.
Praise for the First Edition:
". . . readable, informative and at times witty . . . never stops being concise and well written . . . a book worth a read . . ."
-Statistics in Medicine
"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
"This book is must-have reading for anyone in the business . . ."
-Clinical Chemistry
- Sales Rank: #1381464 in Books
- Published on: 2006-04-21
- Original language: English
- Number of items: 1
- Dimensions: 9.60" h x .82" w x 6.50" l, 1.29 pounds
- Binding: Hardcover
- 272 pages
Review
"With this book in hand, people who manage the people who manage clinical trials can intelligently supervise their staff." (Journal of Clinical Research Best Practices, November 2007)
"…a useful tool for understanding the entire clinical trial process." (Journal of Biopharmaceutical Statistics, Vol. 17, Issue 3, 2007)
From the Back Cover
This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting.
Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards.
This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous 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"—includethe following material:
- Should the trials be conducted?
- Put it in the computer and keep it there
- Staffing for success
- Designing trials and determining sample size
- Budgeting
- Recruiting and retaining patients and physicians
- Data management
- Monitoring the trials
- Data analysis
- After action review
- Exception handling
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 an indispensable resource.
Praise for the First Edition:
". . . readable, informative and at times witty . . . never stops being concise and well written . . . a book worth a read . . ."
—Statistics in Medicine
"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
"This book is must-have reading for anyone in the business . . ."
—Clinical Chemistry
About the Author
Phillip Good, Ph.D., a graduate of UC Berkeley's statistics program, is the author of sixteen published books. He has 23 years of experience in the pharmaceutical and medical device industries, first with Upjohn, and then as an independent consultant. He has taught anatomy and biology, and has also served as Calloway Professor of Computer Science at the University of Georgia at Fort Valley. Dr. Good has lectured extensively throughout the world, including an appointment as traveling lecturer for the American Statistical Association.
Most helpful customer reviews
0 of 0 people found the following review helpful.
Not good quality. But
By Amazon Customer
This book was purchased new. However, the print is very light as if it were a photo copy. Not good quality. But, based on the other reviews, this is a common issue so I will keep the book instead of returning it for a better copy.
0 of 0 people found the following review helpful.
A must for managers in the pharma industry
By S. Horn
Awesome resource and guide. Big help in understanding what was going on in the field. Helped us improve our clinical trial planning process.
0 of 0 people found the following review helpful.
Looks like a photocopy with a cover
By MSS
The pages look like poor photocopies and the printing is very light. Not a very quality book. The content is ok.
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