Data Monitoring Committees in Clinical Trials

Publisher : John Wiley & Sons

ISBN-13 : 0470854154

Page : 208 pages

Rating : 4.5/5 from 154 voters

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.

More Books:

Data Monitoring Committees in Clinical Trials
Language: en
Pages: 208
Authors: Susan S. Ellenberg
Categories: Mathematics
Type: BOOK - Published: 2003-01-17 - Publisher: John Wiley & Sons

There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This gr
Data and Safety Monitoring Committees in Clinical Trials
Language: en
Pages: 191
Authors: Jay Herson
Categories: Medical
Type: BOOK - Published: 2009-03-13 - Publisher: CRC Press

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author’s experience in servin
The Data Safety Monitoring Board - Module A
Language: en
Pages:
Authors: Kalman Dubov
Categories: Medical
Type: BOOK - Published: 2022-01-09 - Publisher: Kalman Dubov

A key function during clinical trials is the Data Safety Monitoring Board (DSMB). The board is composed of several experts who review the investigational trial
Data Monitoring Committees in Clinical Trials
Language: en
Pages: 496
Authors: Susan S. Ellenberg
Categories: Medical
Type: BOOK - Published: 2019-01-14 - Publisher: John Wiley & Sons

The authoritative guide for Data Monitoring Committees—fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceut
Data and Safety Monitoring Committees in Clinical Trials, Second Edition
Language: en
Pages: 241
Authors: Jay Herson
Categories: Mathematics
Type: BOOK - Published: 2016-12-19 - Publisher: CRC Press

Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I
Data and Safety Monitoring Committees in Clinical Trials
Language: en
Pages: 241
Authors: Jay Herson
Categories: Mathematics
Type: BOOK - Published: 2016-12-19 - Publisher: CRC Press

Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I
Data Monitoring in Clinical Trials
Language: en
Pages: 374
Authors: David L. DeMets
Categories: Medical
Type: BOOK - Published: 2006-06-22 - Publisher: Springer Science & Business Media

From the authors of "Fundamentals of Clinical Trials" which has sold over 15,000 copies world wide since its publication in 1998. No competition yet as the text
Fundamentals of Clinical Trials
Language: en
Pages: 361
Authors: Lawrence M. Friedman
Categories: Medical
Type: BOOK - Published: 1998 - Publisher: Springer Science & Business Media

The randomized control clinical trial has become the gold standard scientific method for the evaluation of pharmaceuticals, biologics, devices, procedures and d
Alzheimer's Disease Drug Development
Language: en
Pages: 387
Authors: Jeffrey Cummings
Categories: Medical
Type: BOOK - Published: 2022-03-31 - Publisher: Cambridge University Press

Provides a definitive overview of the complex ecosystem facilitating Alzheimer's Disease drug research and development. Demonstrates a drug's journey from in th
Handbook of Neuroemergency Clinical Trials
Language: en
Pages: 360
Authors: Wayne M. Alves
Categories: Science
Type: BOOK - Published: 2006-01-18 - Publisher: Elsevier

During the 1990’s, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of