(Statistics in Practice) 2nd Edition
by Susan S. Ellenberg (Author), Thomas R. Fleming (Author), David L. DeMets (Author)
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.
