Kurzbeschreibung There has been substantial growth in the use of data monitoring committees in clinical trials, particularly in the pharmaceuticals industry. This book details the operation of data monitoring committees and provides an authoritative guide to their establishment and responsibilities, serving as an invaluable guide for all those involved in clinical trials.
Aus dem Inhalt Introduction
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
