Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice)
$84.24
Description
Book Synopsis: 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.
Details
Are you managing or conducting clinical trials? Is ensuring the safety and efficacy of your trials a top priority for you? Look no further than the authoritative guide, "Data Monitoring Committees in Clinical Trials: A Practical Perspective". This fully revised and updated second edition offers practical advice and a comprehensive overview of the establishment, purpose, and responsibilities of Data Monitoring Committees (DMCs). With the number of clinical trials on the rise, it's crucial to have a reliable system in place to monitor data on safety and efficacy.
With its emphasis on practicality, this book addresses challenging issues that DMCs face in real-world situations. From the composition and independence of DMCs to the statistical, philosophical, and ethical considerations, this guide covers it all. It even delves into determining when a DMC is needed, providing you with comprehensive foundational knowledge of clinical trial oversight.
Not only does this second edition provide recent examples to illustrate DMC principles, but it also reflects current developments and practices in clinical trial oversight. It covers the most up-to-date information on DMC policies, issues in monitoring trials using new designs, and recent trial publications. Plus, there's a new chapter addressing legal issues that affect DMC members, ensuring you have a well-rounded understanding of the topic.
Don't miss out on this must-have text for anyone engaged in DMC activities or involved in clinical trials. Whether you're a trial sponsor, clinical trial researcher, regulatory professional, or associated with clinical trials in academic, government, or industry settings, "Data Monitoring Committees in Clinical Trials: A Practical Perspective" is the guide you need to ensure the credibility and validity of your studies. Get your copy today and take your clinical trial management to the next level!
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