Susan S. Ellenberg & Thomas R. Fleming 
Data Monitoring Committees in Clinical Trials 
A Practical Perspective

-The authoritative guide for Data Monitoring Committees—fully revised and updated

The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees.

Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight.

Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making.

* Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees

* Illustrates the types of challenging issues Data Monitoring Committees face in practical situations

* Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations

* Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research

* Expands treatment of current journal publications addressing DMC issues

Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.

Содержание

1 Introduction

2 Responsibilities of the Data Monitoring Committee and Motivating Illustrations

3 Composition of a Data Monitoring Committee

4 Independence of the Data Monitoring Committee: Avoiding Conflicts of Interest

5 Confidentiality Issues Relating to the Data Monitoring Committee

6 Data Monitoring Committee Meetings

7 Data Monitoring Committee Interactions with Other Trial Components or Related Groups

8 Statistical, Philosophical and Ethical Issues in Data Monitoring

9 Determining When a Data Monitoring Committee is Needed

10 Regulatory Considerations for the Operation of Data Monitoring Committees

11 Legal Considerations for DMCs

Об авторе

SUSAN S. ELLENBERG, PHD, is Professor of Biostatistics, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, USA.

THOMAS R. FLEMING, PHD, is Professor of Biostatistics and Statistics, Department of Biostatistics, School of Public Health, University of Washington, USA.

DAVID L. DEMETS, PHD, is Professor Emeritus and Founding Chair of the Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, USA.