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E-BOOK
Title Data monitoring committees in clinical trials : a practical perspective / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets.
Imprint Chichester, West Sussex, England ; Hoboken, NJ : J. Wiley & Sons, ©2002.

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 Internet  Electronic Book    AVAILABLE
Description 1 online resource (xiii, 191 pages) : illustrations
Series Statistics in practice
Statistics in practice (Chichester, England)
Statistics in practice.
Statistics in practice (Chichester, England)
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Print version record.
Subject Clinical trials.
Medical ethics committees.
Clinical Trials Data Monitoring Committees -- organization & administration.
Clinical Trials
Data Collection.
Genre Electronic books.
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.
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.
Other Author Fleming, Thomas R.
DeMets, David L., 1944-
Other Title Print version: Ellenberg, Susan Smith. Data monitoring committees in clinical trials. Chichester, West Sussex, England ; Hoboken, NJ : J. Wiley & Sons, ©2002 0471489867