Ellenberg / Fleming / DeMets Data Monitoring Committees in Clinical Trials

A Practical Perspective
1. Auflage 2002
ISBN: 978-0-470-85415-0
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 208 Seiten, E-Book

Reihe: Statistics in Practice

There has been substantial growth in the use of data monitoringcommittees in recent years, by both government agencies and thepharmaceutical industry. This growth has been brought about byincreasing recognition of the value of such committees insafeguarding trial participants as well as protecting trialintegrity and the validity of conclusions. This very timely bookdescribes the operation of data monitoring committees, and providesan authoritative guide to their establishment, purpose andresponsibilities.
* Provides a practical overview of data monitoring in clinicaltrials.
* Describes the purpose, responsibilities and operation of datamonitoring committees.
* Provides directly applicable advice for those managing andconducting clinical trials, and those serving on data monitoringcommittees.
* Gives insight into clinical data monitoring to those sitting onregulatory and ethical committees.
* Discusses issues pertinent to those working in clinical trials inboth the US and Europe.
The practical guidance provided by this book will be of use toprofessionals working in and/or managing clinical trials, inacademic, government and industry settings, particularly medicalstatisticians, clinicians, trial co-ordinators, and those workingin regulatory affairs and bioethics.

Autoren/Hrsg.

Ellenberg, Susan

Ellenberg, Susan S.

Fleming, Thomas R.

DeMets, David

Demets, David L.

Inhaltsverzeichnis

Introduction
Responsibilities of the Data Monitoring Committee and MotivatingIllustrations
Composition of a Data Monitoring Committee
Independence of the Data Monitoring Committee: Avoiding Conflictsof Interest
Confidentiality Issues Relating to the Data MonitoringCommittee
Data Monitoring Committee Meetings
Data Monitoring Committee Interactions with Other Trial Componentsor Related Groups
Statistical, Philosophical and Ethical Issues in DataMonitoring
Determining When a Data Monitoring Committee Is Needed
Regulatory Considerations for the Operation of Data MonitoringCommittees
Index