Introduction -- Organization of a safety monitoring program for a confirmatory trial -- Meetings -- Clinical issues -- Statistical issues -- Bias and pitfalls -- Data monitoring committee decisions -- Emerging issues
Summary
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. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. Leading you through the types of reports for adverse events and lab values, the author presents the statistical requirements of data monitoring c
Bibliography
Includes bibliographical references (pages 155-166) and index
