A Manager's Guide to the Design and Conduct of Clinical Trials

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9780471788706: A Manager's Guide to the Design and Conduct of Clinical Trials

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

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

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.

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)

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

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Phillip I. Good (Information Research, CA )
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ISBN 10: 0471788708 ISBN 13: 9780471788706
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Descrizione libro John Wiley and Sons. Condizione libro: New. Brand New. Codice libro della libreria 0471788708

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Descrizione libro John Wiley Sons Inc, United States, 2006. Hardback. Condizione libro: New. 2nd Revised edition. Language: English . Brand New Book. 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. Codice libro della libreria AAH9780471788706

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Descrizione libro John Wiley Sons Inc, United States, 2006. Hardback. Condizione libro: New. 2nd Revised edition. Language: English . Brand New Book. 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. Codice libro della libreria AAH9780471788706

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Descrizione libro Wileyand#8211;Blackwell, 2006. HRD. Condizione libro: New. New Book. Shipped from UK in 4 to 14 days. Established seller since 2000. Codice libro della libreria FW-9780471788706

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Descrizione libro John Wiley & Sons Inc. Hardback. Condizione libro: new. BRAND NEW, A Managers' Guide to the Design and Conduct of Clinical Trials (2nd Revised edition), Phillip I. Good, 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. Codice libro della libreria B9780471788706

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Descrizione libro John Wiley Sons Inc, United States, 2006. Hardback. Condizione libro: New. 2nd Revised edition. Language: English . This book usually ship within 10-15 business days and we will endeavor to dispatch orders quicker than this where possible. Brand New Book. 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. Codice libro della libreria BZV9780471788706

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Descrizione libro Wiley-Liss, 2006. Hardcover. Condizione libro: Brand New. 2nd edition. 256 pages. 9.25x6.25x0.75 inches. In Stock. Codice libro della libreria __0471788708

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