Data monitoring committees in clinical trials a practical perspective /
There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecti...
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Main Authors: | |
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Group Author: | ; |
Published: |
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Literature type: | Electronic eBook |
Language: | English |
Series: |
Statistics in practice
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Subjects: | |
Online Access: |
http://onlinelibrary.wiley.com/book/10.1002/0470854162 |
Summary: |
There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. |
Carrier Form: | 1 online resource (xiii, 191 pages) : illustrations. |
Bibliography: | Includes bibliographical references and index. |
ISBN: |
0470854154 9780470854150 0470854162 9780470854167 1280269995 9781280269998 |
Index Number: | R853 |
CLC: | R969.4 |
Contents: | Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- Regulatory considerations for the operation of data monitoring committees. |