Data monitoring in clinical trials : a practical perspective /

Bibliographic Details
Main Authors:	Ellenberg, Susan Smith (Author), Fleming, Thomas R. (Author), DeMets, David L., 1944- (Author)
Format:	eBook
Language:	English
Published:	Hoboken, NJ : John Wiley & Sons, Inc., 2019.
Edition:	Second edition.
Series:	Statistics in practice.
Subjects:	Clinical trials. Clinical Trials Data Monitoring Committees > organization & administration. Clinical Trials as Topic. Data Collection. Clinical Trials Data Monitoring Committees > ethics. Electronic books.
Online Access:	Connect to the full text of this electronic book

Table of 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
Legal considerations for DMCs.