Data and Safety Monitoring Committees in Clinical Trials
Through these positions, Dr. Chow provides technical supervision and guidance to project teams on statistical issues and presentations before partners, regulatory agencies or scientific bodies, defending the appropriateness of statistical methods used in clinical trial design or data analyses or the validity of reported statistical inferences. Chow identifies the best statistical and data management practices, organizes and leads working parties for development of statistical design, analyses and presentation applications, and participated on Data Safety Monitoring Boards in clinical research and development.
Full text of "Clinical Trial Methodology"
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New Releases. Description Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author's experience in serving on many data monitoring committees DMCs and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. Leading you through the types of reports for adverse events and lab values, the author presents the statistical requirements of data monitoring committees and gives advice on how statisticians can best interact with physician members of these committees.
He also shows how physicians think differently about safety data than statisticians, proving that both views are needed. Product details Format Hardback pages Dimensions x x Other books in this series.
Inference Principles for Biostatisticians Ian C. Add to basket. Cluster Randomised Trials Richard J. Biosimilars Shein-Chung Chow. Clinical Trial Methodology Karl E. Definitions Safety Data Deaths.
Sources of Bias. Review quote "I found this book very useful as a clinical biostatistician with little experience with serving on a DMC. But also biostatisticians with more experience in DMCs can profit from this book since it helps in evaluating their own performance. Though the book primarily focuses on pharmaceutical industry trials, it is almost equally useful for those working on investigator-initiated trials.
In summary, audiences ranging from novice clinical research practitioners to biostatisticians will find this comprehensive guide to data and safety monitoring committees a valuable addition. For someone new to the area, this text will provide a valuable introduction quickly and effectively.
Adaptive designs in clinical trials: why use them, and how to run and report them
At the same time, the presentation style will allow those with more knowledge to move through the material expeditiously, and they will also benefit. The material is presented in a very accessible format and is particularly well suited to new DMC members, or those considering such an opportunity. The material is very useful, the presentation is effective, and a strong recommendation is appropriate.
This book would be particularly useful for anyone who becomes a DSMC member for the first time or for sponsors so that they can have a greater understanding of the DSMC's role.