This book summarizes the author's experience in serving on many data monitoring committees 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 -sponsored trials.
This book summarizes the author's experience in serving on many data monitoring committees 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 -sponsored trials.
Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.
Inhaltsangabe
Preface to the Second Edition. Introduction. Organization of a Safety Monitoring Program for a Confirmatory Trial. Meetings. Clinical Issues. Statistical Issues. Biases and Pitfalls. DMC Decisions. Emerging issues. Appendix.
Preface to the Second Edition. Introduction. Organization of a Safety Monitoring Program for a Confirmatory Trial. Meetings. Clinical Issues. Statistical Issues. Biases and Pitfalls. DMC Decisions. Emerging issues. Appendix.
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