Data monitoring in clinical trials :
Ellenberg, Susan Smith,
Data monitoring in clinical trials : a practical perspective / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets. - Second edition. - xxii, 468 pages : illustrations - Statistics in practice . - Statistics in practice. .
Preceded by Data monitoring in committees in clinical trials : a practical perspective / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets. 2002.
Includes bibliographical references and index.
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 -- Legal considerations for DMCs.
9781119512653 (hardcover)
2018043881
Clinical Trials Data Monitoring Committees--organization & administration
Clinical Trials as Topic
Data Collection--methods
Clinical Trials Data Monitoring Committees--ethics
W 20.55.C5 / 2019
Data monitoring in clinical trials : a practical perspective / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets. - Second edition. - xxii, 468 pages : illustrations - Statistics in practice . - Statistics in practice. .
Preceded by Data monitoring in committees in clinical trials : a practical perspective / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets. 2002.
Includes bibliographical references and index.
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 -- Legal considerations for DMCs.
9781119512653 (hardcover)
2018043881
Clinical Trials Data Monitoring Committees--organization & administration
Clinical Trials as Topic
Data Collection--methods
Clinical Trials Data Monitoring Committees--ethics
W 20.55.C5 / 2019