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

Hardcover (Print)
Used and New from Other Sellers
Used and New from Other Sellers
from $57.48
Usually ships in 1-2 business days
(Save 59%)
Other sellers (Hardcover)
  • All (10) from $57.48   
  • New (5) from $117.58   
  • Used (5) from $57.48   

Overview

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.

Read More Show Less

Editorial Reviews

From the Publisher
"…essential reading for anyone establishing, joining or interacting with data monitoring committees…" (Journal of Clinical Research Practices, September 2007)

"...meets an important need...of interest to the broad spectrum of individuals ivolved in clinical trials..." (Controlled Clinical Trials)

"This wonderful addition to Wiley's 'Statistics in Practice' series is the definitive how-to-do-it manual for running a DMC.." (IRB: Ethics & Human Research , January/February 2003)

"…This is the sort of book that RECs need access to for reference…" (Bulletin of Medical Ethics, February 2003)

"…an excellent starting point …for anyone involved in setting up a data monitoring committee for a clinical trial…" (Short Book Reviews, April 2003)

"…an extremely useful addition…highly recommended…" (Statistical Methods in Medical Research, Vol.12, No.2, 2003)

"...highly recommended, perhaps even required, for those on DMC's...a book well written. I recommend it for library purchase." (The Statistician)

"......clearly required reading for scientists working on clinical trials..." (Good Clinical Practice Journal, Dec 2003)

"...would recommend it to any statistician in the pharmaceutical industry who has any dealing with DMCs..." (Pharmaceutical Statistics, Vol 2, 2003)

"There is very little to criticize about this book…[it] is well written, addressing philosophical, statistical and practical issues…" (Statistics in Medicine, 2004; 23)

“…well organized…invites the reader to go on…” (Statistical Methods in Medical Research, No.13 2004) 

Read More Show Less

Product Details

  • ISBN-13: 9780471489863
  • Publisher: Wiley
  • Publication date: 9/9/2002
  • Series: Statistics in Practice Series , #6
  • Edition number: 1
  • Pages: 208
  • Sales rank: 1,442,375
  • 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

Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star

(0)

4 Star

(0)

3 Star

(0)

2 Star

(0)

1 Star

(0)

Your Rating:

Your Name: Create a Pen Name or

Barnes & Noble.com Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & Noble.com that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & Noble.com does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at BN.com or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation

Reminder:

  • - By submitting a review, you grant to Barnes & Noble.com and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Noble.com Terms of Use.
  • - Barnes & Noble.com reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & Noble.com also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on BN.com. It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

 
Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)