Data monitoring committees in clinical trials : a practical perspective A Practical Perspective Statistics in Practice Series

There has been substantial growth in the use of data monitoring committees, particularly within the pharmaceutical industry. This book provides a guide to their establishment, purpose and responsibilities and provides a practical overview of data monitoring in clinical trials.

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