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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.

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+++ Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics) save

Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics)

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"Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics)" Feature

Learn rigorous statistical methods to ensure valid clinical trials

This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions.

The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and medical and statistical professionals involved in clinical trials. The Second Edition greatly expands its coverage, ranging from statistical principles to controversial topics, including alternative medicine and ethics. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First Edition will discover completely new chapters, including:
* Contexts for clinical trials
* Statistical perspectives
* Translational clinical trials
* Dose-finding and dose-ranging designs


Each chapter is accompanied by a summary to reinforce the key points. Revised discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge, and updated references are provided to direct readers to the most recent literature.

This text distinguishes itself with its accessible and broad coverage of statistical design methods--the crucial building blocks of clinical trials and medical research. Readers learn to conduct clinical trials that produce valid qualitative results backed by rigorous statistical methods.