Product Description

A valuable new edition of the trusted, practical guide to managing data in clinical trials

Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided.

While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements.

Newly featured topics include:
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The growing availability of "off-the-shelf" solutions for clinical trials
*

Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry
*

The increasing use of the Internet in the collection of data and management of trials
*

Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines
*

Development of Standard Operating Procedures for the conduct of clinical trials

Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

Product Details

• Amazon Sales Rank: #727392 in Books
• Published on: 2007-08-15
• Original language: English
• Number of items: 1
• Binding: Hardcover
• 208 pages

Review
"The book is useful for anyone who wants to understand the entire process and how decision made at one stage can have profound affects on the next." (Journal of Clinical Research Best Practices, May 2006)

"...interesting and well-written...the book will be of most use in someone?s personal collection. I would most definitely recommend this book to a colleague.... I would also recommend this book as a course test." (Statistical Methods in Medical Research, Vol. 10, No. 1, 2001)

From the Publisher
From design plan to final analysis, this timely text covers every step of data management in clinical trials. Provides up-to-date information on the planning phase, use of computers and other technology, and training and education. Discusses how to implement Good Clinical Practice and incorporate alternative (and optimal) approaches. Explores differences in how trials are conducted for AIDS, cancer and other major diseases and contrasts European and American approaches. For trials of all sizes and scopes.

From the Back Cover

A valuable new edition of the trusted, practical guide to managing data in clinical trials

Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided.

While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements.

Newly featured topics include:

• The growing availability of "off-the-shelf" solutions for clinical trials

• Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry

• The increasing use of the Internet in the collection of data and management of trials

• Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines

• Development of Standard Operating Procedures for the conduct of clinical trials

Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

Customer Reviews

Not a good book and insane price
I don't think the author has enough experience in the Data Management field.

Out of Date
The methodologies described are out of date. The descriptions are inadequate.

Management of Data in Clinical Trials (Wiley Series in Proba
The authors gave an excellent overview af scientific skills used in the field of clinical research.