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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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Bibliographic Details
Main Authors: Ellenberg, Susan Smith.
Group Author: Fleming, Thomas R.; DeMets, David L., 1944-
Published:
Literature type: Electronic eBook
Language: English
Series: Statistics in practice
Subjects:
Clinical trials.
Medical ethics committees.
Clinical Trials Data Monitoring Committees.
data collection.
MEDICAL > Laboratory Medicine.
Clinical Trials Data Monitoring Committees > organization and administration.
Data Collection > methods.
Biostatistics.
Electronic books.
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.

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