Data Monitoring Committees in Clinical Trials: A Practical Perspective

1. Auflage 2002
ISBN: 978-0-471-48986-3
Verlag: WILEY

Buch, Englisch, 208 Seiten, Format (B × H): 160 mm x 237 mm, Gewicht: 426 g

Reihe: Wiley Series in Statistics in

There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.

* Provides a practical overview of data monitoring in clinical trials.

* Describes the purpose, responsibilities and operation of data monitoring committees.

* Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees.

* Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees.

* Discusses issues pertinent to those working in clinical trials in both the US and Europe.

The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.

Autoren/Hrsg.

Ellenberg, Susan S.

Ellenberg, Susan

Fleming, Thomas R.

Fleming, Thomas

Demets, David L.

DeMets, David

Fachgebiete

• Mathematik | Informatik EDV | Informatik Daten / Datenbanken
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

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