Original PDF Ebook – Data Monitoring Committees in Clinical Trials2nd EditionA Practical Perspective – 9781119512653

Original PDF Ebook – Data Monitoring Committees in Clinical Trials2nd EditionA Practical Perspective – 9781119512653

­The authoritative guide for Data Monitoring Committees–fully revised and updated_x000D_
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._x000D_
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._x000D_
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._x000D_
• Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees_x000D_
• Illustrates the types of challenging issues Data Monitoring Committees face in practical situations_x000D_
• Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations_x000D_
• Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research