Data Monitoring Committees in Clinical Trials: A Practical Perspective / Edition 1

Data Monitoring Committees in Clinical Trials: A Practical Perspective / Edition 1

by Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets
     
 

ISBN-10: 0471489867

ISBN-13: 9780471489863

Pub. Date: 09/09/2002

Publisher: Wiley

The use of data monitoring committees within the pharmaceutical industry, often causes conflicts with clinical trials coordinators and uncertainty regarding regulatory compliance. This volume offers a practical approach to data monitoring.  See more details below

Overview

The use of data monitoring committees within the pharmaceutical industry, often causes conflicts with clinical trials coordinators and uncertainty regarding regulatory compliance. This volume offers a practical approach to data monitoring.

Product Details

ISBN-13:
9780471489863
Publisher:
Wiley
Publication date:
09/09/2002
Series:
Statistics in Practice Series, #6
Pages:
208
Product dimensions:
6.28(w) x 9.15(h) x 0.66(d)

Table of Contents

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

Index

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